Explore the medical device requirements currently available for Netherlands, organized by topic and linked to official sources.
Which claims, audiences, channels, approvals, and restrictions apply?
Suppliers of medical devices are prohibited from promising, offering or granting benefits (gunstbetoon) to promote sales, with statutory exceptions (e.g. participation costs, services, benefits of small value, discounts and rebates).
National advertising-adjacent restriction beyond MDR art. 7 (misleading claims).
Acting in violation of art. 7 of Regulation (EU) 2017/745 or art. 7 of Regulation (EU) 2017/746 (misleading claims) is a criminal offence in the Netherlands, punishable by imprisonment of at most two years or a fine of the sixth category; after two prior administrative fines for the same conduct it is punishable by up to six months' detention or a third-category fine.
Complemented by administrative fines up to the sixth category or 10% of annual turnover (Wmh art. 14).
What expires, what is retained periodically, and when must renewal start?
EU certificates issued by notified bodies are valid for the period they indicate, which may not exceed five years. On application by the manufacturer the validity of the certificate may be extended for further periods, each not exceeding five years, based on a re-assessment in accordance with the applicable conformity assessment procedures; any supplement follows the same rules.
Effective from 2021-05-26
Does the event require internal documentation, notice, prior approval, transfer, or a new application?
Changes to an existing notification (wijziging) and deregistrations (afmelding) are handled by Farmatec with a maximum processing time of 3 months; notifications already in NOTIS but not yet in EUDAMED can be mutated online in NOTIS until 27 November 2026, after which registration continues in EUDAMED.
· Effective until 2026-11-27
NOTIS mutation window ends 27 November 2026.
Which clinical or IVD performance evidence or study is required and accepted?
The Central Committee on Research Involving Human Subjects (CCMO) is the (sole) competent authority in the Netherlands for clinical investigations with medical devices and performance studies with IVDs and processes the notifications for these studies; the IGJ supervises compliance with the rules. IVDR performance studies must in many cases be notified to the CCMO (situation changed per 26 May 2022).
IGJ: 'De Centrale Commissie Mensgebonden Onderzoek (CCMO) is de (enige) bevoegde autoriteit' and processes notifications; WMO/Wmh art. 16 provide the legal framework.
A positive WMO opinion issued before 26 May 2021 for a clinical investigation under the old directives is treated as a positive opinion for scientific research with medical devices under the new regime, provided execution of the investigation had already commenced.
Overgangsrecht in the Wet medische hulpmiddelen.
Is the product a device, IVD, accessory, software, or borderline product locally?
A medical device is any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more specified medical purposes (diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability; investigation, replacement or modification of the anatomy or of a physiological or pathological process; or providing information by means of in vitro examination of specimens derived from the human body), and which does not achieve its principal intended action by pharmacological, immunological or metabolic means. Software intended for medical purposes is itself a device.
Effective from 2021-05-26
Which evidence, local deltas, formats, and signatures are required?
The technical documentation required to demonstrate conformity with the general safety and performance requirements must be drawn up in accordance with Annex II to Regulation (EU) 2017/745 (device description and general information, information supplied by the manufacturer, information on design and manufacture, general safety and performance requirements, benefit-risk analysis and risk management, product verification and validation) together with the post-market surveillance technical documentation of Annex III, and kept available to the competent authorities.
Effective from 2021-05-26
Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?
The Dutch notification duty falls on a manufacturer established in the Netherlands or on an authorised representative established in the Netherlands representing a non-EU manufacturer; importers and distributors have no national registration role.
IGJ names 'een in Nederland gevestigde gemachtigde van een niet-EU-fabrikant' as a notificatieplichtige.
Which establishment licences, importer permissions, and distribution controls apply?
Manufacturers, authorised representatives and importers must register through the electronic system (EUDAMED) and provide the Annex VI Part A Section 1 information before placing devices, other than custom-made devices, on the market, obtaining a Single Registration Number; where the conformity assessment procedure requires a notified body, the information must be supplied before applying to it. Importers additionally bear the general obligations of Art. 13 (verify CE marking and EU declaration of conformity, ensure storage and transport conditions, register complaints).
Effective from 2021-05-26
What regulator fee applies to this class, route, event, and date?
The Minister of VWS may charge the costs of activities carried out under Regulations (EU) 2017/745, 2017/746 and 2019/1020 to the person for whom they are performed; the amounts are set by ministerial regulation.
Legal basis for the national fees implemented in the Regeling medische hulpmiddelen (art. 3) and the Regeling tarief notificatie medische hulpmiddelen.
Which label and IFU elements, languages, symbols, and translation controls apply?
The information to be supplied by the manufacturer and the general summary (as required by the MDR/IVDR) must be drawn up in Dutch.
National language delta beyond MDR art. 10(11); adopted under Wmh art. 4(1).
By way of exception, the information may be drawn up in English if the device is intended to be used exclusively by a healthcare professional, on the condition that that professional has an adequate command of English.
Exception to the Dutch default of art. 1(1).
The information, documentation and field safety notice (e.g. under MDR art. 10(14) and art. 89(8)) must be drawn up in Dutch or English.
Broader language tolerance than the IFU default of art. 1(1).
Which current law, regulation, guidance, and transition provisions apply?
Wet medische hulpmiddelen (BWBR0042755, law of 24 October 2019) — competent authorities, supervision, tariffs, exemptions, enforcement
Besluit medische hulpmiddelen (BWBR0043470) — implant card, fillers, reprocessing of single-use devices
Regeling medische hulpmiddelen (BWBR0043450 / Staatscourant 2020, 24039) — language requirements, custom-made device lists, free-sale certificate, appointment of authorities, notification tariff amendment
IGJ states that only a few supplementary matters (supervision, IFU language) are nationally regulated.
Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?
Until all EUDAMED modules are functional, manufacturers send their reports on serious incidents, FSCA with field safety notice (FSN), periodic summary reports (PSUR) and trend reports to the IGJ via the secured email channel stated on the IGJ contact page.
Interim national channel; EUDAMED becomes the reporting point once fully functional.
Which current form, portal, account, and submission package must be used?
NOTIS (https://hulpmiddelen.farmatec.nl, login with eHerkenning level 2+) for national notifications, custom-made device registration, export-certificate applications and mutations; EUDAMED for actor/device registration from 28 May 2026; Article 59 MDR / Article 54 IVDR exemption applications by email to CIBGOntheffingenMedischeHulpmiddelen@minvws.nl; vigilance reports (MIR/FSCA forms) by email to meldpunt@igj.nl
NOTIS portal URL and login requirement stated on the Farmatec export page; notification/mutation flows on the Farmatec notifications page.
Which QMS, audit, inspection, and certificate scope is accepted or required?
Manufacturers must establish, document, implement, maintain, keep up to date and continually improve a quality management system that ensures compliance with the Regulation in the most effective manner and in a manner proportionate to the risk class and the type of device; the system covers design and manufacture through final inspection and is assessed by the notified body as part of conformity assessment (Annex IX Chapter I).
Effective from 2021-05-26
Which recall, FSCA, notice, and authority-coordination duties apply?
Field safety corrective actions (FSCA) with the field safety notice (FSN) are reported to the IGJ using the FSCA form, sent by email to meldpunt@igj.nl (as PDF attachment), until EUDAMED is fully functional.
Same interim channel as MIR incident reports.
The Minister of VWS is empowered to take the special measures for the protection of public health referred to in MDR art. 98(1) (and the IVDR equivalent), such as requiring recall or withdrawal of devices.
Article heading: 'Bijzondere maatregelen ter bescherming van de volksgezondheid'.
Which registration, notification, listing, reliance, or conformity route applies?
EUDAMED (mandatory from 28 May 2026 under Besluit (EU) 2025/2371) is the registration surface for devices; the national NOTIS system (Farmatec) continues for the Dutch notification duty, custom-made device registration, export certificates and mutations of existing notifications until 27 November 2026
Effective from 2026-05-28
Custom-made device registration stays in NOTIS (art. 2 Regeling medische hulpmiddelen).
The Netherlands maintains a national notification duty for devices and IVDs first placed on the market by a manufacturer or authorised representative established in the Netherlands, covering Class I devices, custom-made devices, system/treatment procedure packs and IVDs of all risk classes; notification is done via the Farmatec system (NOTIS). The duty rests on transition articles 24-25 of the Wet medische hulpmiddelen, which keep the notification articles of the old decrees in force until EUDAMED becomes operational.
Legal basis cited on the IGJ page: Wet medische hulpmiddelen, art. 24/25 (overgangsrecht keeping old Besluit medische hulpmiddelen / Besluit in-vitro diagnostica notification articles alive).
Which foreign decisions or evidence can be reused, with what effect and conditions?
Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.
Prior approval / evidence record
CE Mark (EU MDR)
Yes
Law No. 89/2014 as amended is built on the EU framework, so the CE certificate and the technical documentation behind it are the substance of the ABPM dossier rather than an optional extra. ABPM publishes no shorter period for CE-marked devices.
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
Conformity of a device with the essential requirements is confirmed by issuance of the CE marking document or, equally, by an FDA certification document; for CE the manufacturer follows the conformity procedure set in the technical rules adopted by Council of Ministers decision.
The original 2014 text accepted only CE marking; FDA certification was added by Law 21/2020 (in force 2020).
Prior approval / evidence record
CE Mark (EU MDR)
Yes
Usable as technical and QMS evidence in the dossier. Algeria requires its own registration decision and publishes no recognition route or origin-based reduction.
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
class-ii
Class II
medium
Declaration of Conformity
15
15
working-days
official-verified
Disposición ANMAT 9688/2019 (texto actualizado) — arts. 4–6 registration clocks, arts. 13/15/18 modification and transfer clocks
https://servicios.infoleg.gob.ar/infolegInternet/anexos/330000-334999/332646/texact.htm
2019-12-03
2026-08-29
6
12
months
4
7
months
No
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
EU CE Mark
Yes
Recognized for documentation
2-4 months
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
class-iv
Class IV
highest
Full Registration
110
110
working-days
official-verified
Disposición ANMAT 9688/2019 (texto actualizado) — arts. 4–6 registration clocks, arts. 13/15/18 modification and transfer clocks
https://servicios.infoleg.gob.ar/infolegInternet/anexos/330000-334999/332646/texact.htm
2019-12-03
2026-08-29
18
24
months
12
16
months
Yes
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
class-iii
Class III
high
Registration with clinical data
110
110
working-days
official-verified
Disposición ANMAT 9688/2019 (texto actualizado) — arts. 4–6 registration clocks, arts. 13/15/18 modification and transfer clocks
https://servicios.infoleg.gob.ar/infolegInternet/anexos/330000-334999/332646/texact.htm
2019-12-03
2026-08-29
12
18
months
8
12
months
Yes
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
A device that has no Armenian state registration can still be imported, but the import (conformity) certificate file must contain a document confirming that the device is authorised for use — state registration or free circulation — in its country of manufacture or in an IMDRF member country, or a reasoned reference to such a document, including a Declaration of Conformity with references to the relevant registers. This is the origin-country free-sale certificate requirement: a Turkish, Korean, Chinese or European exporter must produce its home-country registration/free-sale evidence (or an IMDRF-country equivalent) even though the device is not registered in Armenia. The document is mandatory paperwork; the Armenian expert organisation still examines the file and the Ministry of Health still decides.
Registration / free circulation in the country of manufacture, or in any IMDRF member country — US FDA, EU member states (CE), Japan PMDA, Korea MFDS, China NMPA, Canada, Australia, Brazil, Singapore, UK — evidenced by a registration certificate, free-sale certificate or a Declaration of Conformity with register references
Origin Country Evidence
Evidence Only
Import Control
Yes
Yes
Language: Armenian. Verbatim, Government Decree No. 429-Ն of 30.03.2023, Annex No. 2, para. 2(2)(a): "պետական գրանցում չունեցող բժշկական արտադրատեսակների համար՝ ա. բժշկական արտադրատեսակի արտադրող երկրում կամ Բժշկական արտադրատեսակների կարգավորող մարմինների միջազգային համաժողովի (IMDRF) անդամ երկրներում կիրառման թույլտվությունը (պետական գրանցումը, ազատ կիրառումը) հավաստող փաստաթուղթ կամ դրա վերաբերյալ փաստարկված տեղեկանք, այդ թվում՝ բժշկական արտադրատեսակների համապատասխանության հայտարարագիր (Declaration of Conformity) համապատասխան գրանցամատյանների հղումով". Translation: "for medical devices without state registration: a. a document confirming authorisation for use (state registration, free circulation) in the country of manufacture of the medical device or in member countries of the International Medical Device Regulators Forum (IMDRF), or a reasoned reference thereto, including a Declaration of Conformity for the medical device with reference to the relevant registers".
Prior approval / evidence record
EU CE marking under MDR/IVDR
Yes
An EU member state is an IMDRF member, so a CE-marked and EU-registered device meets the same simplified-route gate under Article 46(4); the CE certificate is not itself an Armenian marketing authorisation.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
Armenia registers medical devices under two national procedures: a general procedure and a simplified procedure. The simplified procedure applies to a device that is registered in a country that is a member of the International Medical Device Regulators Forum (IMDRF) or that is prequalified by the World Health Organization. IMDRF members include the United States (FDA), the EU member states (CE marking), Japan (PMDA), Korea (MFDS), China (NMPA), Canada, Australia, Brazil, Singapore and the United Kingdom, so a US FDA 510(k)/PMA clearance, an EU CE mark, a Japan PMDA approval and a Korea MFDS approval all satisfy the gate. The device is still registered in Armenia by the Armenian authority — the foreign registration opens the shortened procedure, it does not replace the Armenian certificate.
Registration in any IMDRF member country — US FDA 510(k)/PMA, EU CE marking under MDR/IVDR (any EU member state), Japan PMDA, Korea MFDS, China NMPA, Health Canada, Australia TGA, Brazil ANVISA, Singapore HSA, UK MHRA — or WHO prequalification of the device
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Language: Armenian. Verbatim, Article 46(4): "Սույն հոդվածի 3-րդ մասով սահմանված կարգի համաձայն՝ բժշկական արտադրատեսակները գրանցվում են ընդհանուր և պարզեցված ընթացակարգերով: Պարզեցված ընթացակարգը կիրառվում է բժշկական արտադրատեսակների շրջանառությունը կարգավորող մարմինների միջազգային համաժողովի (IMDRF) անդամ երկրում գրանցված կամ Առողջապահության համաշխարհային կազմակերպության նախաորակավորած բժշկական արտադրատեսակների համար:" Translation: "Under the procedure laid down by part 3 of this article, medical devices are registered under general and simplified procedures. The simplified procedure applies to medical devices registered in a member country of the International Medical Device Regulators Forum (IMDRF) or prequalified by the World Health Organization." Article 46 was amended by the Law of 5 December 2024 ՀՕ-502-Ն; the consolidated expression is the version in force from 31.05.2026.
Prior approval / evidence record
class-iii
Class III — ARTG inclusion
highest
Inclusion in the ARTG on overseas or TGA conformity assessment evidence
20
20
working-days
6
9
months
3
5
months
No
No
Yes
official-verified
TGA — processing your application for inclusion of a medical device: the decision is notified within 20 working days after the day the application fee was paid
https://www.tga.gov.au/products/medical-devices/application-and-market-authorisation/supply-medical-device/medical-device-inclusion-process/processing-your-application-inclusion-medical-device
2026-08-30
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
geo:aus
EU CE under MDR/IVDR
Evidence Reuse
facilitated
Product Marking
Yes
Yes
Prior approval / evidence record
class-iib
Class IIb — ARTG inclusion
high
Inclusion in the ARTG on overseas or TGA conformity assessment evidence
20
20
working-days
1.5
2
months
1
1.5
months
No
No
Yes
official-verified
TGA — processing your application for inclusion of a medical device: the decision is notified within 20 working days after the day the application fee was paid
https://www.tga.gov.au/products/medical-devices/application-and-market-authorisation/supply-medical-device/medical-device-inclusion-process/processing-your-application-inclusion-medical-device
2026-08-30
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
class-iia
Class IIa — ARTG inclusion
medium
Inclusion in the ARTG on overseas or TGA conformity assessment evidence
20
20
working-days
1
1.5
months
0.75
1
months
No
No
Yes
official-verified
TGA — processing your application for inclusion of a medical device: the decision is notified within 20 working days after the day the application fee was paid
https://www.tga.gov.au/products/medical-devices/application-and-market-authorisation/supply-medical-device/medical-device-inclusion-process/processing-your-application-inclusion-medical-device
2026-08-30
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
EU CE Mark
Yes
Abridged assessment route - major timeline reduction
30-50%
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
geo:aut
EU CE under MDR/IVDR
Single Market Validity
direct
Product Marketing
Yes
No
No
EU baseline confirmed via the European Commission CE-marking page (supporting context for the single-market validity edge).
Prior approval / evidence record
EU CE marking under MDR/IVDR
No
Same position: the recognition list approved by Cabinet Resolution No. 480 of 26 December 2023 is applied to medicinal products only, so a CE mark does not displace the national dossier and expertise.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
Registration of a medical device in Bahrain requires a Quality Assurance Certificate for the legal manufacturer, which is accepted in the form of a CE certificate under Directive 93/42/EEC, Regulation 2017/745, Directive 98/79/EC or Regulation 2017/746, or an FDA Certificate to Foreign Government (CFG), verified on the issuing body's website. The foreign approval is mandatory supporting paperwork for a local review that still runs in full, not a route that shortens it.
EU CE marking under MDD 93/42/EEC, MDR 2017/745, IVDD 98/79/EC or IVDR 2017/746; US FDA Certificate to Foreign Government (CFG)
Origin Country Evidence
Evidence Only
Premarket Review
Yes
Yes
Verbatim source passage: "Quality Assurance Certificate (QAC) - CE directives 93/42/EEC, 2017/745, 98/79/EC, 2017/746 or FDA Certificate to Foreign Government (CFG) for the Legal manufacturer with the address matching the artwork along with verification evidence ... Not applicable for class I non-sterile and Class A/others IVD."
Prior approval / evidence record
EU CE certificate under MDD 93/42/EEC, MDR 2017/745, IVDD 98/79/EC or IVDR 2017/746, or US FDA Certificate to Foreign Government
Yes
Mandatory supporting documentation for a local review that still runs in full, not a route that shortens it: the CE certificate or CFG is the Quality Assurance Certificate required for the legal manufacturer, and for class III and class D IVDs the EC Design Examination certificate or CFG is an additional class-specific dossier item.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
At renewal, Bahrain requires a Free Sale Certificate (FSC) or Certificate to Foreign Government issued by the regulatory authority of the country of origin or of a reference country (Registration Guideline 9.1, section 10 item 4). The guideline's glossary (item 14) defines reference countries as Saudi Arabia, USA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, New Zealand, France, Holland and Belgium, so a certificate from one of those authorities substitutes for an origin-country free-sale certificate. A Free Sale Certificate is also required on manufacturer acquisition (section 12).
Free Sale Certificate or Certificate to Foreign Government from the country of origin or from a reference country (Saudi Arabia, USA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, New Zealand, France, Holland, Belgium)
Origin Country Evidence
Evidence Only
Premarket Review
Yes
Yes
Verbatim source passages: "Free Sale Certificate (FSC) or Certificate to foreign government issued by the regulatory authority of the country of origin or a reference country." and "Reference countries: Saudi Arabia, USA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, New Zealand, France, Holland, Belgium."
Prior approval / evidence record
To obtain an NHRA classification letter, the applicant must supply a Free Sale Certificate or Registration Certificate issued by the competent authority of the country of origin or by one of the reference countries listed in the classification guideline (SFDA, USA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, New Zealand, France, Holland, Belgium), together with a recognised quality assurance certificate such as ISO 13485, CE mark or FDA.
Registration certificate or Free Sale Certificate from SFDA (Saudi Arabia), US FDA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, New Zealand, France, Holland or Belgium
Origin Country Evidence
Evidence Only
classification
Yes
Yes
Verbatim source passage: "1. Free Sale Certificate OR Registration Certificate issued from competent authority in country of origin classifies the product as a medical device. 2. Free Sale Certificate OR Registration Certificate issued from one of the following reference countries: (SFDA, USA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, Newzland, France, and Holland, Belgium.)."
Prior approval / evidence record
For class III medical devices and class D IVDs, Bahrain requires an EC Design Examination certificate or an FDA Certificate to Foreign Government for the legal manufacturer; the same document must be supplied for class IIb devices if available. The named foreign instrument is a mandatory class-specific dossier item, not a shortened review.
EC Design Examination certificate (EU notified body); US FDA Certificate to Foreign Government (CFG)
Origin Country Evidence
Evidence Only
Premarket Review
Yes
Yes
Verbatim source passage: "For class III medical devices as well as class D IVD's, an EC Design examination certificate or an FDA Certificate to Foreign Government (CFG) for the legal manufacturer is required along with verification evidence ... This document needs to be submitted for class IIB medical devices if available."
Prior approval / evidence record
EU CE Mark
Yes
Usable as supporting technical evidence on the same terms, with no recognition route and no published reduction.
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
Dossier must include regulatory status evidence: for Class C and D devices a Free Sale Certificate from any one of EU, USA, Canada, Australia and Japan plus an FSC from the country of origin; a conformity-assessment certificate or equivalent must also be submitted. (Class B: FSC from country of origin.)
Guideline s.4.7 accepts QMS/product certification or marketing authorization issued by a National Regulatory Authority/notified body outside Bangladesh; a Device Master File is required only where CE/US FDA approvals are not available.
Regulatory reference
The national production-inspection requirement is triggered differently where the devices are already in circulation in the USA or EU member states; the inspection case list excludes foreign class 1 devices (non-sterile) and treats sites previously declared only for US/EU-circulating or EAEU-registered devices separately.
Prior approval / evidence record
CE Mark (EU MDR)
Yes
Technical and QMS documentation can be reused, but Belarus runs its own state registration and publishes no recognition route for a CE certificate.
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
geo:bel
EU CE under MDR/IVDR
Single Market Validity
direct
Product Marketing
Yes
No
No
Loi du 22 décembre 2020 relative aux dispositifs médicaux is the Belgian implementing act; it sets the language regime, the FAMHP as competent authority, the distribution notification duty and the national vigilance channel, all of which sit on top of a valid CE certificate rather than replacing it.
Prior approval / evidence record
EU CE marking
No
No named-approval fast track exists. A CE certificate or ISO 13485 certificate is accepted as the quality-system evidence of numeral 2.3.1 of the device manual, not as an authorisation.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
A registration application for a class I, IIa, IIb or III medical device must include proof that the device is marketed in the country of the manufacturer or in one of the countries of the European Union — a 'Free Sale Certificate' or similar document. This is a mandatory documentary element of the dossier and is required alongside, not instead of, the EU conformity certificate.
Evidence of marketing in the manufacturer's country or in an EU member state (Free Sale Certificate or similar document)
Origin Country Evidence
Evidence Only
Premarket Review
Yes
Yes
Original (bs): as quoted. Translation: 'proof that the medical device is marketed in the country of the manufacturer or in one of the countries of the European Union'. The same requirement is repeated for in vitro diagnostic devices in Član 69. stav (1) tačka e), and restated by the Agency's current documentation list (30.10.2025) as '„Free Sale Certificate“ ili sličan dokument'.
Prior approval / evidence record
EU CE marking — EC certificate issued under Directives 90/385/EEC or 93/42/EEC
Yes
Law čl. 102(3) requires a manufacturer whose conformity is determined by a conformity-assessment body recognised in the EU to affix the CE marking recognised in BiH, and the Agency's Instruction of 6 February 2025 sets out the conditions and documentation for recognising an EC certificate issued under Directive 90/385/EEC or 93/42/EEC that was valid on 26 May 2021 and not withdrawn, including the MDR Annex VII application-and-contract evidence. Recognition is an administrative act of the Agency under čl. 100 and 101 of the Law and čl. 68 of the Pravilnik; it does not replace entry in the Register, which under Pravilnik čl. 65(8) is what confers the right to place the device on the market.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
Where the conformity of a medical device with the general and special requirements is determined by a conformity-assessment body recognised in the European Union, the manufacturer marks the device with the CE marking, and that marking is recognised in Bosnia and Herzegovina in place of the national BiH conformity marking. The CE route therefore replaces the national conformity-assessment and marking step, but the device must still be entered in the Register of medical devices kept by the Agency before it may be placed on the market.
EU CE Marking — conformity assessment determined by a body recognised in the EU; in practice an MDR (EU) 2017/745 certificate, or during the transition a legacy MDD 93/42/EEC / AIMD 90/385/EEC EC certificate that remains valid under MDR Article 120
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Original (bs): as quoted. Translation: 'By way of exception from paragraph (2) of this Article, a manufacturer of a medical device whose conformity with the general and special requirements is determined by a conformity-assessment body recognised in the EU must mark the medical device with the CE marking, which is recognised in BiH.' The same rule is repeated in the implementing Ordinance (Pravilnik, Član 38. stav (3)), which adds that the CE mark or certificate of conformity implies conformity with the requirements and directives of the European Union. Source bytes are the official gazette text as published in the legacy YUSCII-derived encoding used by „Službeni glasnik BiH“; the excerpt is normalised to standard Latin orthography (č/ć/š/ž/đ) without changing any wording.
Prior approval / evidence record
An EC certificate issued by an authorised body under Directives 90/385/EEC or 93/42/EEC from 25 May 2017, which was valid on 26 May 2021 and has not subsequently been withdrawn, remains in force beyond the end date printed on the certificate until 31 December 2027 for class III devices, implantable class IIb devices and AIMD devices, and until 31 December 2028 for the remaining class IIb devices, class IIa devices and class I devices placed on the market sterile or with a measuring function. The Agency accepts such certificates only where the manufacturer holds a signed MDR Annex VII written agreement with a notified body and confirms no significant change in design or intended purpose and no unacceptable risk.
Legacy EU EC certificate under MDD 93/42/EEC or AIMD 90/385/EEC extended by MDR (EU) 2017/745 Article 120
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Original (bs): as quoted. Translation: 'If an EC certificate was issued by an authorised body in accordance with Directives 90/385/EEC and 93/42/EEC from 25 May 2017 and was valid on 26 May 2021 (the start of application of the EU MDR Regulation) and has not subsequently been withdrawn, it remains in force after the end of the period stated on the certificate, up to the following dates: (a) 31 December 2027 — for class III devices, implantable class IIb devices ... and AIMD devices; (b) 31 December 2028 — for class IIb devices not covered by point (a), class IIa devices and class I devices placed on the market in a sterile state or with a measuring function.' The guidance cites Article 120 of Regulation (EU) 2017/745 and Pravilnik Član 68.
Prior approval / evidence record
EU MDR (Regulation (EU) 2017/745) notified-body certificate
Yes
The Agency's Instruction is expressly framed as the response to the EU's transition from the MDD/AIMD to the MDR and cites MDR Article 120, so an MDR certificate is recognised on the same basis as an EC certificate. Bosnia and Herzegovina is not an EU member and the MDR is not directly applicable; the certificate enters the national procedure as a conformity input.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
For in vitro diagnostic medical devices the registration dossier must contain a certificate of conformity with the directives and regulations of the European Union (CE marking certificate, EC certificate) — except for in vitro diagnostic devices on List D — together with the manufacturer's declaration of conformity against the European directive stating the list to which the device belongs. Class I (other) non-IVD devices are likewise exempt from the EC-certificate limb.
EU in vitro diagnostic certificate (CE marking certificate / EC certificate) under the EU IVD directives or IVDR
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Original (bs): as quoted. Translation: '(c) a certificate of conformity of the in vitro medical device with the directives and regulations of the European Union (CE marking certificate, EC certificate) or a certificate of conformity of the medical device, original or certified copy in the country of origin, except for in vitro medical devices on List D; (d) a manufacturer's declaration of conformity with the European directive for in vitro medical devices, stating exactly the list to which the device belongs (Declaration of conformity), original or certified copy in the country of origin'. Source bytes are the official gazette text as published in the legacy YUSCII-derived encoding used by „Službeni glasnik BiH“; the excerpt is normalised to standard Latin orthography (č/ć/š/ž/đ) without changing any wording.
Prior approval / evidence record
Since 26 May 2021 a manufacturer's declaration of conformity issued against Directive 93/42/EEC can no longer be regarded as a valid document for a Class I risk device and will not be accepted; a declaration of conformity complying with Regulation (EU) 2017/745 must be submitted to the Agency for applications filed after that date. Any significant change in the design or intended purpose of the device requires a fresh conformity assessment and consequently a new declaration of conformity.
EU MDR (EU) 2017/745 declaration of conformity; the legacy MDD 93/42/EEC declaration is no longer accepted
Origin Country Evidence
Evidence Only
Premarket Review
Yes
Yes
Original (bs): as quoted. Translation: 'After 26 May 2021, a manufacturer's declaration of conformity with the requirements of Directive 93/42/EEC cannot be considered a valid document, i.e. it will not be accepted. In relation to the said medical devices, for applications submitted to the Agency after 26 May 2021, a manufacturer's declaration of conformity in accordance with the requirements of Regulation (EU) 2017/745 must be submitted.'
Prior approval / evidence record
Stringent Regulatory Authority approval — ICH members (European Commission, US FDA, Japan MHLW/PMDA), ICH observers (Swissmedic, Health Canada) or an authority associated with an ICH member through a legally binding mutual recognition agreement (including Australia, Iceland, Liechtenstein and Norway)
No
The SRA definition in G01 s.3.1.26 is used for dossier and reference purposes rather than as an automatic grant: an SRA approval does not by itself confer a Botswana registration, and it benefits the applicant only through the abridged pathway's proof-of-reference-agency requirement, which is defined by the separate Reference Regulatory Authority concept.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
For a Class B, C or D general medical device, an existing approval from a Stringent Regulatory Authority, a BoMRA-recognised Reference Regulatory Authority, or WHO prequalification, together with a valid ISO 13485 certificate, qualifies the application for the abridged assessment pathway instead of full evaluation. Class B accepts one approval from an RRA, an SRA or WHO. Class C requires at least one SRA or WHO approval, plus at least three years on the market in an SRA jurisdiction and no safety issues in the previous three years. Class D requires approvals from at least two RRAs including one SRA, plus the same three-year marketing and safety conditions. The local application and the final BoMRA decision are retained in all cases.
Any Stringent Regulatory Authority (ICH member: European Commission, US FDA, Japan MHLW/PMDA; ICH observers: EFTA/Swissmedic, Health Canada; ICH-associated via MRA: Australia, Iceland, Liechtenstein, Norway) or a BoMRA-recognised Reference Regulatory Authority, or WHO (with valid ISO 13485 certification or equivalent)
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Effective from 2024-12-09
SRA is defined in the same guideline at s. 3.1.26 as an ICH member (European Commission, US FDA, MHLW/PMDA), an ICH observer (EFTA as represented by Swissmedic, and Health Canada), or an authority associated with an ICH member through a legally binding mutual recognition agreement (Australia, Iceland, Liechtenstein, Norway). China NMPA is NOT an SRA on that definition. RRA is defined at s. 3.1.25 by cross-reference to BoMRA policy 'Recognition and-or Reliance on Information on Medical Devices including IVDs from Regional and International Regulatory Agencies BOMRA-ER-MED-Policy No.1', which was not found published on the BoMRA site.
Prior approval / evidence record
For devices that are not on the interim register/listing, BoMRA's exemption guideline makes a foreign marketing authorisation a required piece of evidence: a copy or proof of the marketing authorisation issued by a relevant Reference Regulatory Authority, Singapore HSA, China NMPA (Class A and B only) or SAHPRA (Class A and B only), and/or a CE certificate issued by a European notified body under MDD 93/42/EEC, IVDD 98/79/EC, MDR (EU) 2017/745 or IVDR (EU) 2017/746, and/or proof of a WHO EUL or Prequalification acceptance letter. Approval places the device on an exempted list with a six-month validity.
Reference Regulatory Authorities recognised by BoMRA; Singapore Health Sciences Authority; China NMPA (Class A and B only); South African Health Products Regulatory Authority (Class A and B only); CE certificate from a European notified body under MDD/IVDD/MDR/IVDR; WHO EUL or WHO Prequalification acceptance letter
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Effective from 2023-04-01
Excerpt read from the OCR pass over BoMRA's scanned copy (download/98/exemptions/25635/...). In s. 5.5.1 the parenthetical '(Only for Class A & B medical devices)' is interleaved by the PDF's line order and applies to China NMPA and to SAHPRA; the wording has not been altered but the reading is flagged. BoMRA's own revision sheet records the addition of 'China National Medical Products Administration (Only for Class A & B medical devices)' at Issue 3.0 and 'by European notified bodies (Except Class A)' at Issue 2.0.
Prior approval / evidence record
EU CE Mark
No
Not an AREE under IN 290/2024 Art. 6
None
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
In at least one Ministry of Health procurement, equipment must comply with one of five named international safety standards — US FDA Standard, European Union CE MARK, Australian TGA Standard, Canadian CSA Standard or Japanese Standard. This is a tender technical requirement for the supply of equipment, not a market-authorisation recognition rule: it creates no registration pathway, shortens no review, and does not name Japan PMDA, Korea MFDS or China NMPA.
US FDA standard; EU CE Marking; Australian TGA standard; Canadian CSA standard; Japanese standard (named generically, not as PMDA approval)
Procurement Admission
Evidence Only
procurement
No
No
Verbatim from the tender document (44 pages, text layer, retrieved HTTP 200, 629,727 bytes): 'The equipment must comply to either one of the five international safety standards namely; US FDA Standard, European Union CE MARK, Australian TGA Standard, Canadian CSA Standard or Japanese Standard. The equipment must also comply with relevant AAMI Standards such as UL2601 and IEC601-1.' Searches of the document for 'PMDA', 'MFDS', 'NMPA', 'Korea' and 'China' return no matches, which is why the sourceApproval string does not name those authorities. The bounded claim recorded in value is deliberately limited to what this one procurement states.
Prior approval / evidence record
geo:bgr
EU CE under MDR/IVDR
Single Market Validity
direct
Product Marketing
Yes
No
No
EU-level source confirms the single-market validity of CE marking; national Bulgarian layer (ЗМИ registration for class I route, Bulgarian IFU, wholesale permits, vigilance) still applies as conditions state.
Prior approval / evidence record
EU CE Mark
No
Not recognized
None
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
CE Mark (EU MDR)
Yes
Chile requires ISP registration only for the controlled device families; for everything else the certificate supports importation rather than a registration decision. Where registration does apply, the ISP period does not vary with origin.
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
Hainan Boao Pilot Zone
Fast-track initial use with real-world data collection
4 months vs 3-5 years standard
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
EU CE Mark
Yes
Required as home country approval
Required documentation
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
class-iia
Class IIa
medium
Registration (NSO)
2
2
working-days
official-verified
Decreto 4725 de 2005 — INVIMA statutory review clocks (Arts. 21-22)
https://normograma.invima.gov.co/normograma/compilacion/docs/decreto_4725_2005.htm
2026-08-25
1
2
months
2
3
months
No
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
class-iib
Class IIb
high
Registration (RSO)
90
90
working-days
official-verified
Decreto 4725 de 2005 — INVIMA statutory review clocks (Arts. 21-22)
https://normograma.invima.gov.co/normograma/compilacion/docs/decreto_4725_2005.htm
2026-08-25
6
12
months
4
6
months
No
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
For imported devices, a certificate from the competent authority of the country of origin stating the product is authorized for production or marketing there is required; if the product is not used in the country of origin, a free-sale certificate from a reference country (EU, United States, Canada, Japan, Australia) or a country with a mutual recognition agreement is required instead.
Prior approval / evidence record
EU CE Mark
Yes
Reference-country origin under Decreto 3275/2009
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
CE Mark (EU MDR)
Yes
Accepted as evidence of conformity alongside the certificate of free sale. Decreto 38409-S art. 34.2 sets the same decision deadline for every class, so origin does not move it.
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
The device marketing-authorisation dossier must contain a certified copy of the conformity attestation obtained through the international procedures recognised by the AIRP. This is the operative foreign-approval document — a CE certificate or equivalent conformity attestation — and it is a mandatory attachment for every device to be homologated, not a fast-track key. The AIRP does not publish which international procedures it recognises, and the dossier still requires full technical documentation, a risk-management plan and an essential-requirements checklist.
EU CE marking / conformity attestation obtained under the international procedures recognised by the AIRP (the AIRP does not publish the list of recognised procedures)
Origin Country Evidence
Evidence Only
Premarket Review
Yes
Yes
French original. Translation: 'A certified copy of the conformity attestation obtained through the international procedures recognised by the AIRP.' The document is a scanned four-page AIRP procedure with no text layer; the passage was read by OCR of the official AIRP PDF at 200 dpi with Tesseract (fra). The identical dossier item appears in the UEMOA harmonised dossier annexes ('une copie certifiée de l'attestation de conformité obtenue suite aux procédures internationales reconnues par l'autorité compétente'), which corroborates the wording.
Prior approval / evidence record
EU CE marking / notified-body certificate
No
Not a substitute for the AIRP Autorisation de Commercialisation, but a certified copy of the attestation de conformité obtained through the international procedures recognised by the AIRP is a required item of the Ivorian dossier, so the CE technical file is reusable evidence.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
A device lawfully bearing CE marking under Regulation (EU) 2017/745 or Regulation (EU) 2017/746 may be placed on the Croatian market on the strength of that certificate. Croatia secures the implementation of the two Union regulations by the Zakon o provedbi Uredbe (EU) 2017/745 ... (NN 100/2018), which establishes the national competent authorities, the national procedural duties and the penalties, but creates no additional national product approval, no national certificate and no national re-assessment of the notified body's technical assessment.
EU CE Marking under MDR (EU) 2017/745 / IVDR (EU) 2017/746
Abridged Or Recognition Route
facilitated
Product Marketing
Yes
No
Croatian (source language). Verbatim: "Ovim se Zakonom osigurava provedba sljedećih uredbi Europske unije: – Uredbe (EU) 2017/745 Europskog parlamenta i Vijeća od 5. travnja 2017. o medicinskim proizvodima ... – Uredbe (EU) 2017/746 Europskog parlamenta i Vijeća od 5. travnja 2017. o in vitro dijagnostičkim medicinskim proizvodima ...". Translation: "This Act secures the implementation of the following European Union regulations: Regulation (EU) 2017/745 ... Regulation (EU) 2017/746 ...".
Prior approval / evidence record
CE Mark (EU MDR)
Yes
Registration in a country with an essential-principles programme opens proceder B and waives some test reports
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
A CE mark under Regulation (EU) 2017/745 (or 2017/746 for in vitro diagnostic medical devices) is the domestic route into Cyprus and is valid throughout the EU/EEA; CYMDA states that it has so far imposed no additional requirement beyond those provided for by Union and national legislation. What a CE holder still owes Cyprus is local: notify each device to CYMDA under Decree No. 7, ensure the importer is identified on the device, its packaging or an accompanying document, supply the information needed for safe and proper use in English and/or Greek (Greek mandatory for use by non-healthcare professionals), register in EUDAMED, and accept the market-surveillance and penalty powers under Law 225(I)/2022.
EU CE Marking under Regulation (EU) 2017/745 (MDR) for medical devices and Regulation (EU) 2017/746 (IVDR) for in vitro diagnostic medical devices
Abridged Or Recognition Route
facilitated
Product Marketing
Yes
No
Effective from 2025-11-06
Greek source, notice of 6 November 2025. Translation of the excerpt: 'the Competent Authority, responsible for market surveillance and the safety of medical devices in the Republic of Cyprus, and for supervising the application of the relevant Regulations, has so far not imposed any additional requirement beyond those provided for by Union and national legislation.' The excerpt supports the bounded claim that Cyprus itself adds nothing to the Union route; the CE mark's EU/EEA-wide effect rests on Regulation (EU) 2017/745 (source res-cy-mdr-2017-745).
Prior approval / evidence record
geo:cze
EU CE under MDR/IVDR
Single Market Validity
direct
Product Marketing
Yes
No
No
EU-level baseline confirming the edge; national obligations verified separately in this file.
Prior approval / evidence record
geo:dnk
EU CE under MDR/IVDR
Single Market Validity
direct
Product Marketing
Yes
No
No
Danish-language duties under BEK 1731/2025 § 3 still apply to CE-marked devices sold in Denmark.
Prior approval / evidence record
WHO Strict Authorities — US FDA, Health Canada, Japan NIHS, Australia TGA, EMA, Icelandic Medicines Agency, Norwegian Medicines Agency, Liechtenstein AML
Yes
Eligibility for the simplified registration procedure under Resolución No. 000004 on a Certificate of Free Sale plus a good-manufacturing-practices certificate from that authority, for new registrations and renewals of imported products; the remaining legal requirements still apply and DIGEMAPS retains the decision.
No published period: the MSP service listing shows 'Inmediatamente' rather than a number of days.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
An imported product that has previously been authorised by a WHO Strict Authority or by a regional reference regulatory authority (ARNr) of the PAHO/PARF network may be registered through the simplified procedure, evidenced by a Certificate of Free Sale and a Certificate of Good Manufacturing Practices issued by that authority, in addition to the other requirements of current legislation. Products that any of those authorities has refused to authorise are excluded from the simplified procedure.
WHO Strict Authorities: US FDA; Health Canada; Japan NIHS (National Institute of Health Science); Australia TGA; EMA; Icelandic Medicines Agency; Norwegian Medicines Agency; Liechtenstein (Amt für Lebensmittelkontrolle und Veterinärwesen). PAHO/PARF regional reference authorities (ARNr): ANMAT (Argentina), ANVISA (Brazil), CECMED (Cuba), INVIMA (Colombia), COFEPRIS (Mexico)
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Effective from 2016-04-01
Spanish. Source PDF is an image-only scan (Adobe 'Image Conversion Plug-in'); the passage below was read from the scan by OCR and OCR spacing artefacts were normalised. Original: "Productos importados que previamente hayan sido autorizados por Autoridades Estrictas (OMS) y/o de Autoridades Reguladoras de Referencia Regional (ARNr) de la Red Panamericana para la Armonización de la Reglamentación Farmacéutica (RED PARF/OPS), lo cual debe ser avalado mediante la presentación del 1. Certificado de Libre Venta y Certificado de Buenas Prácticas de Manufactura emitido por las referidas autoridades en adición a los demás requisitos establecidos en la legislación vigente." English: imported products previously authorised by WHO Strict Authorities and/or PAHO/PARF regional reference authorities, evidenced by the free-sale and GMP certificates issued by those authorities, in addition to the other requirements of current legislation. The recognised-authority list (TERCERO) names FDA, Health Canada, NIHS, TGA, EMA, the Icelandic and Norwegian medicines agencies and Liechtenstein as Strict Authorities, and ANMAT, ANVISA, CECMED, INVIMA and COFEPRIS as ARNr.
Prior approval / evidence record
CE Mark (EU MDR)
Yes
A device already registered in a reference country is what makes the ARCSA homologation route available, and the certificate of free sale plus that reference registration are the substance of the dossier. ARCSA publishes its periods per procedure, not per origin.
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Regulatory reference
EDA recognizes reference countries: EU member states plus Australia, Canada, Iceland, Ireland, Japan, New Zealand, Norway, Switzerland, United Kingdom and United States of America; devices from these countries get reduced documentation, while devices from non-reference countries need extra evidence.
Variation guideline v03 (res-eg-variations) lists the same set plus Croatia and Liechtenstein.
Regulatory reference
Japan is a reference country (Technical Committee decision of March 2011); the same registration procedures as EU classes I, IIa, IIb and III apply to Japanese classes I, II, III and IV respectively. Japanese documents and labelling must be translated into English (by the Japanese manufacturer or an accredited Egyptian translation office).
Effective from 2023-08-29
A parallel procedure exists for UKCA-marked devices (CAMD index, 07/2023 v02).
Prior approval / evidence record
EU CE Mark
Yes
A CE certificate and ISO 13485:2016 are the international quality certificates that open the GL.CAMD.002 route; Class I non-sterile devices are exempt from the CE requirement
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
For Estonia the CE marking route is not a foreign approval but the domestic route: Regulations (EU) 2017/745 and (EU) 2017/746 apply directly in Estonia and the Estonian Medical Devices Act does not apply where those regulations apply, so a device holding a valid MDR/IVDR conformity assessment enters the Estonian market through the Union route. Only the national residual duties attach: notification of first distribution (MSS § 26(4)), Estonian-language information (MSS § 16(3)-(5)), data submission to the MSA register (MSS § 29) and the Union registration duties.
EU CE marking under Regulation (EU) 2017/745 (MDR) or Regulation (EU) 2017/746 (IVDR)
Abridged Or Recognition Route
facilitated
Product Marketing
No
Yes
Effective from 2023-01-01
Estonian source. Verbatim: "(2) Käesolevat seadust ei kohaldata juhtudel, kui kohaldub Euroopa Parlamendi ja nõukogu määrus (EL) 2017/745, milles käsitletakse meditsiiniseadmeid, ... või Euroopa Parlamendi ja nõukogu määrus (EL) 2017/746 in vitro diagnostikameditsiiniseadmete kohta ning millega tunnistatakse kehtetuks direktiiv 98/79/EÜ ja komisjoni otsus 2010/227/EL (ELT L 117, 05.05.2017, lk 176–332)." Consolidated text RT I, 12.07.2025, 23, in force 01.10.2025–30.09.2026.
Prior approval / evidence record
In the low-risk device route (Class I non-IVD and Class A IVD), EFDA states that if the applicant submits a CE certificate, the free-sale certificate or marketing authorisation certificate is not mandatory. Otherwise the applicant must supply an original and valid free-sale or marketing authorisation certificate from the responsible regulatory authority where the device is marketable. This is a documentation substitution for the lowest-risk classes and does not shorten the substantive review.
EU CE certificate (including CE marking under MDR 2017/745 / IVDR 2017/746 or the predecessor directives)
Abridged Or Recognition Route
Evidence Only
Premarket Review
Yes
Yes
Effective from 2026-06-30
Verbatim: 'If the applicant submits a CE certificate, these certificates are not mandatory. Otherwise, the applicant should submit an original and valid free sale certificate or marketing authorization certificate issued by the responsible regulatory authority where the medical device is marketable, to attest that the device is marketable, without any restriction at their jurisdiction.'
Prior approval / evidence record
A medical device that already holds a marketing authorisation, registration certificate or free-sale certificate from one of the authorities EFDA lists as a Stringent Regulatory Authority can be filed on the SRA route (EFDA/GDL/046 §9.4). The applicant still submits the complete administrative and technical dossier required by the ordinary registration guidelines, but EFDA reviews it as a verification exercise focused on the genuineness of the submitted information rather than a de-novo assessment, so the application takes shorter processing time. EFDA keeps the right to conduct a full assessment and to request further information whenever it deems necessary.
US FDA marketing authorisation / registration certificate / free-sale certificate; Japan MHLW; Australia TGA; Singapore HSA; a competent authority of one of the 27 EU Member States (Directive 93/42/EEC, Directive 98/79/EC, MDR 745/2017, IVDR 746/2017); UK MHRA; Health Canada; South Korea MFDS
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Effective from 2026-06-25
Verbatim: 'At present, EFDA accepts the registration submissions as an SRA or prequalified products application if they're supported by one or more of the following document(s). 1. A Marketing Authorization certificate or registration certificate or free sale certificate issued by one of the following competent national regulatory authority: US Food and Drug Administration; Ministry of Health, Labour and Welfare, Japan; Trapeutic Goods Administration, Australia; Health Science Authority, Singapore; Competent Authorities from one of the 27 Member States of the European Union who are responsible in Europe for the oversight of Directive 93/42/EEC, Directive 98/79/EC, MDR 745/2017, IVDR 746/2017.; Medicine and Healthcare Products Regulatory Agency, UK; Health Canada, Canada; Ministry of Food and Drug Safety, South Korea'. The passage also states: 'The applicants should submit all documentation required for registration of medical devices through full assessment path way, but it takes shorter processing time as it will focus on verifiying genuinness of submitted information.' Typographical errors are reproduced as they appear in the source.
Prior approval / evidence record
Legacy Device Transition
Extended deadlines for MDD-certified devices
Until Dec 2027 (Class III) or Dec 2028 (others)
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
MDD CE Mark
Yes
Extended market access during transition
Until 2027-2028
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
geo:fin
EU CE under MDR/IVDR
Single Market Validity
direct
Product Marketing
Yes
No
No
Laki lääkinnällisistä laitteista 719/2021 is the Finnish act giving effect to MDR and IVDR. It names Fimea, sets the language duties and the national notification and vigilance obligations, none of which is a second conformity assessment.
Prior approval / evidence record
geo:fra
EU CE under MDR/IVDR
Single Market Validity
direct
Product Marketing
Yes
No
No
Ordonnance n° 2022-582 adapted the Code de la santé publique to MDR, and Décret n° 2026-299 recast its regulatory part. One national restriction genuinely narrows the edge rather than merely adding paperwork: Art. L5211-3-2 CSP prohibits reprocessing single-use devices, France having exercised the MDR Art. 17 opt-out, so a lawfully CE-marked reprocessed single-use device cannot be placed on the French market.
Prior approval / evidence record
For the three device-type categories that are registered under the Law on Medicines — dental material, invasive mechanical means of contraception, and means of diagnostics (test systems, allergens, reagents, sera) — the administrative dossier may carry, in place of a WHO-format Certificate of Pharmaceutical Product and in place of the GMP document or manufacturing licence that substitutes for it, an ISO certificate or an EC certificate of the product manufacturer, or a free sale certificate. This is origin-country documentary evidence: it is required paperwork for the national registration dossier, and the Georgian registration decision is still taken locally.
EU EC certificate of the product manufacturer; ISO certificate of the product manufacturer; or a free sale certificate — accepted in lieu of a WHO-format Certificate of Pharmaceutical Product
Origin Country Evidence
Evidence Only
Premarket Review
Yes
Yes
Language of source: English consolidated text on matsne.gov.ge. Verbatim: "d) a (original) CPP in the form recommended by the World Health Organization, and if it is not available – a document certifying that the pharmaceutical product has been manufactured according to the GMP (Good Manufacturing Practices) standard, or a pharmaceutical product manufacturing licence issued by an authorised body of the manufacturing country. In the case of dental material, an invasive mechanic means of contraception, or means of diagnostics, an ISO certificate or an EC certificate of the product manufacturer, or a free sale certificate may be submitted;"
Prior approval / evidence record
EU CE marking under MDR/IVDR
No
No recognition route for devices. An EC certificate of the product manufacturer is, however, expressly accepted in the administrative dossier of the three device-type categories registered under the Law on Medicines in place of a certificate of pharmaceutical product (Article 11^11(19)(d)), which is documentary relief rather than an approval. Georgia separately recognises EU technical regulations as such under Article 56(11) of the Product Safety and Free Movement Code.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
geo:deu
EU CE under MDR/IVDR
Single Market Validity
direct
Product Marketing
Yes
No
No
The Medizinprodukterecht-Durchführungsgesetz is the German implementing act: § 85 designates the authorities, § 4 sets the national notification duties fed into DMIDS, § 6 provides for national classification rulings and § 7 for a special national authorisation. None of these re-opens the conformity assessment behind the CE certificate.
Prior approval / evidence record
CE Mark (EU MDR)
Yes
A CE certificate is the technical dossier and QMS evidence behind a reliance submission, and supports a desk-review waiver of the QMS audit.
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
geo:grc
EU CE under MDR/IVDR
Single Market Validity
direct
Product Marketing
Yes
No
No
EOF publishes the national harmonisation decisions that sit alongside the EU regulations. One of them narrows the edge in substance: EOF decision 91092/01-09-2023 bars skin-applied products containing camphor or menthol that carry health claims from the Greek market, so a CE certificate does not settle market access for that group.
Prior approval / evidence record
Guatemala does operate a reliance route: Norma Técnica 77 versión 8-2023 homologates a Guatemalan health registration on a registration already granted by a WHO-listed authority of high maturity and performance (WLA/ACO, ML3+). Article 2 confines that route expressly to pharmaceutical specialities of chemical synthesis and to vaccines (biological and biotechnological). It does not reach medical devices or in vitro diagnostics.
Approval by a WHO-listed authority (WLA/ACO, maturity level 3 or above) — e.g. US FDA, EMA, Japan PMDA, Korea MFDS — for chemical-synthesis medicines and vaccines only
Abridged Or Recognition Route
none
Premarket Review
Yes
Yes
Spanish source (Guatemala). Translation: "Article 2. Scope of application. This Technical Norm applies to pharmaceutical specialities of chemical synthesis and vaccines (biological and biotechnological) that hold a Health Registration granted by high-maturity-and-performance Regulatory Authorities as defined by the World Health Organization (WHO), published in the official lists of the Department of Regulation and Control of Pharmaceutical and Related Products, hereinafter THE DEPARTMENT." The norm's own title is 'HOMOLOGACIÓN DEL REGISTRO SANITARIO DE MEDICAMENTOS Y VACUNAS'. Art. 4.3 of the same norm defines the WLA/ACO concept and states that authorities reaching at least general maturity level 3 (ML3) qualify.
Prior approval / evidence record
WHO-listed authorities of high maturity and performance (US FDA, EMA, Japan PMDA, Korea MFDS and others)
No
A foreign marketing approval is not among the NT-37 Art. 5.1 dossier items and opens no recognition route for devices. A Certificate of Free Sale from any competent origin-country authority is required paperwork, and a manufacturing-guarantee certificate from a named authority (FDA, DGKC, IFCC, ISO or a GMP certificate) satisfies one dossier item (NT-37 Arts. 5.1.5-5.1.6 and 6.12.6). The full local review still runs.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Regulatory reference
For EU approvals, MDACS accepts EU MDR certificates with Declaration of Conformity, or EU MDD certificates accompanied by an MDD extension declaration letter signed as per Regulation (EU) 2023/607 plus the associated DoC.
Reflects the EU MDR transition extension in HK reliance practice.
Regulatory reference
Pathway 2 accepts marketing approval documents from eight recognised jurisdictions (Chinese Mainland NMPA, USA FDA, EU, Canada, Japan, Singapore, South Korea MFDS, Australia TGA); for example the USA accepts 510(k), PMA or De Novo, and all model/code variants must be covered by the certificate.
A valid Certificate of Free Sale may be requested; certificates must remain valid during assessment (GN-02 clause 8.1).
Prior approval / evidence record
EU CE Mark
Yes
MDR certificates, or MDD certificates with a Regulation (EU) 2023/607 extension letter, satisfy D002; an EU ER or GSPR checklist may then replace the MD-CCL
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
geo:hun
EU CE under MDR/IVDR
Single Market Validity
direct
Product Marketing
Yes
No
No
Hungary states MDR direct applicability on its own regulatory page and names the two national implementing decrees, 4/2009 (III. 17.) EüM rendelet for devices and 8/2003 (III. 13.) ESzCsM rendelet for IVDs. Their content is notification and registration, not re-assessment.
Prior approval / evidence record
Iceland is not an EU member state. The EU route exists in Iceland because the EEA Joint Committee took MDR (EU) 2017/745, IVDR (EU) 2017/746 and Regulation (EU) 2020/561 up into the EEA Agreement (Decisions No 288/2019 and 301/2019 of 13 December 2019, and No 90 of 18 June 2020) and the Icelandic parliament then gave them the force of law by Article 2 of Act No. 132/2020, with the EEA adaptations. The practical consequence is that a CE-marked device lawfully placed on the EEA market may be placed on the Icelandic market and that the substantive obligations are the Union text as adapted, not a separate Icelandic regime.
EEA incorporation of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 (EEA Joint Committee Decisions No 288/2019, No 301/2019, No 90/2020)
Single Market Validity
direct
Regional Harmonisation
No
No
Effective from 2021-05-26
Icelandic. edgeType reuses the established token single_market_validity because the effect is single-market validity; the distinct mechanism recorded here is the EEA treaty incorporation itself (regulatoryLayer regional_harmonisation), which matters to a filer because the citation to give a regulator is the EEA Joint Committee decision read with the national lögfesting, and because the same route extends to all EEA states rather than only to Iceland.
Prior approval / evidence record
Notified body certificate under Regulation (EU) 2017/745 issued in any EEA State
Yes
The certificate and the CE marking it supports are valid for the Icelandic market without any Icelandic recognition step, and no Icelandic authority re-examines the conformity assessment. This is the practical reliance route into Iceland, and the reason Lyfjastofnun operates no national approval of its own.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
A device that carries CE marking under MDR (EU) 2017/745 or IVDR (EU) 2017/746 and a valid EU declaration of conformity may be placed on the Icelandic market and put into service without any Icelandic pre-market approval, registration of the device, or conformity assessment. Iceland applies the same MDR/IVDR text as the EU/EEA single market, so the notified-body certificate is the market-access decision; Iceland runs no parallel review and issues no national device approval of its own.
EU CE under MDR/IVDR (notified-body certificate plus EU declaration of conformity per MDR Annex IV)
Single Market Validity
direct
Product Marketing
No
No
Effective from 2021-05-26
Icelandic. 'Áður en lækningatæki er sett á markað, selt eða tekið í notkun er skylt að CE-merkja tækið í samræmi við nánari fyrirmæli reglugerðanna og það ferli sem sett er fram í IX.–XI. viðauka með reglugerðunum.' marketAccessStrength is written as 'direct' rather than the round's 'facilitated' because no local route exists at all: there is nothing for the CE mark to shorten, and the registry already uses 'direct' with single_market_validity for the other EEA/EFTA states (Norway, Liechtenstein) and the EU member states. 'facilitated' would understate the position and imply a residual Icelandic review.
Prior approval / evidence record
class-a
Class A
low
Registration
45
45
days
official-verified
CDSCO Medical Devices Rules, 2017 (G.S.R. 78(E))
https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/m_device/Medical%20Devices%20Rules%2C%202017.pdf
2026-08-25
6
9
months
3
5
months
No
Yes
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
EU CE Mark
Yes
A free sale certificate from an EU country triggers the same Rule 36(3) waiver of clinical investigation. The EU is not named in the Rule 63(1) proviso, so a no-predicate device still needs the MD-27 route.
None published — the saving is the clinical investigation, not the clock
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
Where a free sale certificate has been issued by the national regulatory authority of Australia, Canada, Japan, an EU country, the United Kingdom or the United States, the import licence is granted without carrying out clinical investigation.
Effective from 2018-01-01
G.S.R. 174(E): for the words 'or the United States of America' the words 'United Kingdom or the United States of America' shall be substituted.
Prior approval / evidence record
EU CE Mark
Yes
Supports the Certificate of Free Sale and the technical evidence in the CSDT, but Kemenkes publishes no shorter period for it
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
PMK 5/2026 Pasal 58(4) requires a Minister-issued izin edar for importing medical devices and PKRT, subject to the specified exceptions. It does not establish whether an abridged or reliance assessment is available in obtaining that local permit.
Effective from 2026-05-04
The former wording incorrectly inferred absence of reliance from a local permit requirement.
Prior approval / evidence record
class-c
Class C
high
Full Registration
30
30
working-days
official-verified
Kemkes Regalkes — evaluation guideline Annex 8 service-standard clocks
https://regalkes.kemkes.go.id/informasi_alkes/Indonesia%20Guideline%20for%20Evaluation%20of%20Medical%20Device%20and%20IVD%202020.pdf
2026-08-25
4
6
months
No
Yes
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
class-d
Class D
highest
Full Registration
45
45
working-days
official-verified
Kemkes Regalkes — evaluation guideline Annex 8 service-standard clocks
https://regalkes.kemkes.go.id/informasi_alkes/Indonesia%20Guideline%20for%20Evaluation%20of%20Medical%20Device%20and%20IVD%202020.pdf
2026-08-25
5
7
months
Yes
Yes
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
class-b
Class B
medium
Registration
30
30
working-days
official-verified
Kemkes Regalkes — evaluation guideline Annex 8 service-standard clocks
https://regalkes.kemkes.go.id/informasi_alkes/Indonesia%20Guideline%20for%20Evaluation%20of%20Medical%20Device%20and%20IVD%202020.pdf
2026-08-25
4
6
months
No
Yes
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
EU CE Mark
Yes
Origin-market evidence expected in practice; no Iraqi instrument on a reachable source grants an abridged period for it
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
geo:irl
EU CE under MDR/IVDR
Single Market Validity
direct
Product Marketing
Yes
No
No
Re-verified on the Commission CE-marking page; national operator registration and vigilance channels in Ireland are recorded as separate facts.
Regulatory reference
A device registered, or approved for marketing and actually marketed, in a 'recognized state' (מדינה מוכרת) is registered in the Israeli register for a period not exceeding the period it may be marketed in that state, capped at 5 years from Israeli registration. Recognized states are listed in the First Addendum to the law — 21 states including the US, UK, Germany, France, Italy, Spain, the Netherlands, Belgium, Ireland, Denmark, Sweden, Finland, Norway, Iceland, Greece, Portugal, Austria, Switzerland, Australia, Canada and New Zealand (no single 'EU' entry: member states are listed individually).
First Addendum list per the official Sefer HaChukim text of the law held from gov.il.
Regulatory reference
Health Canada medical device licences are among the accepted reference approvals for AMAR registration (listed in the official registration guidelines alongside FDA, CE and TGA); Canadian registrations in principle have no expiry, so a validity of 5 years from the submission date is entered in the approvals table when filing.
Health Canada listed as accepted approval per the AMAR registration guidelines PDF.
Regulatory reference
Pilot: for register registration, MDR CE certificates issued by notified bodies from non-recognized states (accredited by the EU under MDR) are recognized; the pilot has been extended until 31.12.2026, after which ministry policy will be examined in light of its results.
· Effective until 2026-12-31
Regulatory reference
Where registration relies on European approvals extended under EU transition rules, the Israeli register validity is based on the extension granted under the European regulation; the expiry date entered in the application (per new EU rules, e.g. 31.12.2027 or 31.12.2028) must follow those conditions.
Confirms the baseline EU-CE reliance edge.
Regulatory reference
US FDA marketing authorizations (e.g. 510(k)) are primary reference evidence; like other no-expiry approvals, 510(k) clearances are assigned 5-year validity from the submission date in the approvals table. Where EU and US classifications differ, the FDA classification takes precedence, provided the product meets the conditions of the chosen track.
Confirms the baseline US-FDA reliance edge.
Prior approval / evidence record
EU CE Mark
Yes
A recognized-state CE certificate puts a Class I device on the declaration track and an EU Class IIa device or IVDD Self Test / IVDR class B on fast track 1, in both cases with four months of marketing in the recognized state. EU Class IIb and IVDD LIST B / IVDR class C need the CE certificate plus a second independent authority for fast track 2.
Declaration track is up to 48 hours and fast track 1 up to 45 working days, against the 120-day regular-track target
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
geo:ita
EU CE under MDR/IVDR
Single Market Validity
direct
Product Marketing
Yes
No
No
Decreto legislativo 5 agosto 2022, n. 137 is the Italian MDR adaptation, with D.Lgs. 138/2022 doing the same for IVDR. The national layer is registration in the Ministry of Health device database plus the Italian language duties, neither of which revisits the CE decision.
Prior approval / evidence record
EU CE Mark
No
ISO 13485 applicable to Ordinance 169; no abridged Japanese period
2-4 months prep
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
EU CE Mark
Yes
The أسس adopt the EU directives by reference for the class axis, and the annexes require the CE certificate and a free-sale certificate from the country of origin
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
CE Mark (EU MDR)
Yes
Technical and QMS documentation can be reused, but the EAEU route requires its own national expertise. The 70 and 110 working-day service periods in Order ҚР ДСМ-10 do not change with origin.
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
CE Mark (EU MDR)
Yes
Opens the reliance route inside fast track, which replaces the 24-month FIFO review with a 90-day one
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
The medical device registration guideline recognizes marketing clearances from eight listed reference regulatory agencies: Australia TGA, Health Canada, EU Notified Bodies (MDD/AIMDD/IVD Directive certificates), Japan MHLW, US FDA (510(k) or PMA), Ireland HPRA, Saudi Arabia SFDA and Swissmedic. US FDA 510(k)-exempt products do not qualify for the abridged route. Approvals from EU and TGA count as independent reference approvals only if the devices were reviewed and approved by those agencies themselves and not registered on the basis of a Mutual Recognition Agreement (MRA).
Prior approval / evidence record
US FDA approval and the EU route — a CE certificate from an EU-authorized notified body
Yes
Two of the recognised reference authorities for the Abridged Review Pathway and the first two entries in the class B/C/D dossier's product verification and validation list; an accelerated assessment that still runs under Kuwaiti requirements and post-market obligations, with the acceptance decision reserved to the Administration.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
A CE mark under Regulation (EU) 2017/745 (or 2017/746 for IVDs) is the domestic route into Latvia and is valid throughout the EU/EEA. Once the Latvian notification procedure is complete, the notifier is entitled to place the device on the Latvian market without any decision or approval of the State Agency of Medicines; the agency publishes the notification data and the procedure is then deemed complete. What remains are local obligations: a manufacturer without an EU establishment must designate a sole authorised representative, and a distributor established in Latvia must be entered in the LATMED database before making devices available.
EU CE Marking under Regulation (EU) 2017/745 (MDR) for medical devices and Regulation (EU) 2017/746 (IVDR) for in vitro diagnostic medical devices
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
No
Effective from 2023-08-23
Latvian source; translation: '12. The persons referred to in paragraph 9 of these Regulations, after completion of the notification procedure, are entitled to place the medical device on the market of the Republic of Latvia without a decision or approval of the agency.' The excerpt supports the bounded claim that Latvia issues no separate national approval for a CE-marked device; the EU/EEA-wide validity of the CE mark rests on Regulation (EU) 2017/745 itself (source res-lv-mdr).
Prior approval / evidence record
The extended MDR transitional periods run only for devices covered by a certificate issued under Directive 90/385/EEC or Directive 93/42/EEC, or whose pre-2021 declaration of conformity did not require a notified body. As at 15 September 2026 the extended dates are 31 December 2027 for all class III devices and class IIb implantable devices other than certain well-established technologies, and 31 December 2028 for other class IIb devices, class IIa devices and class I devices placed on the market sterile or with a measuring function. A US FDA, Japan PMDA, Korea MFDS or China NMPA approval confers no transitional benefit because it is not a Directive certificate.
none
No Reliance Route
none
Premarket Review
No
Yes
Effective from 2023-03-20
English source. The excerpt is quoted from the amending act; the inserted text uses the defined terms of Regulation (EU) 2017/745 / 93/42/EEC / 90/385/EEC and names no third-country approval.
Prior approval / evidence record
The Lebanese assessment of an implantable device does not address the clinical-evaluation aspects at all: the MOPH health technology unit explicitly relies on the work already carried out by the regulatory authorities of the GHTF countries. A device whose clinical evidence was assessed by the FDA, an EU notified body, Health Canada, the TGA or Japan therefore does not have that clinical evidence re-reviewed in Lebanon.
Regulatory authorities of the GHTF countries (US FDA, EU member states, Health Canada, Australia TGA, Japan MHLW/PMDA)
Assessment Report Reliance
facilitated
Premarket Review
Yes
Yes
Effective from 2013-11-01
Source language French. Original: "Les aspects relatifs à l'évaluation clinique ne seront pas abordés en faveur d'une exploitation des travaux déjà effectués par les autorités réglementaires dans les pays de la GHTF." Translation: "The aspects relating to clinical evaluation will not be addressed, in favour of making use of the work already done by the regulatory authorities in the GHTF countries."
Prior approval / evidence record
To obtain authorisation to place a medical device on the Lebanese market the device must conform to at least one of the regulations in force in Canada, Australia, Japan, the United States or an EU member state. An FDA, CE, Health Canada, TGA or Japan approval is therefore the conformity basis on which the Lebanese file is admitted rather than a starting point for a fresh assessment. The device must in addition satisfy Lebanese standards where such standards exist.
US FDA 510(k)/PMA; EU CE marking (notified-body certificate plus manufacturer declaration of conformity); Health Canada; Australia TGA; Japan MHLW/PMDA
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Effective from 2013-11-01
Source language French. Original: "Pour obtenir l'autorisation de mise sur le marché libanais, le dispositif médical doit être conforme à au moins une des réglementations en vigueur dans les pays suivants: Canada, Australie, Japon, Etats Unies, pays membres de l'union européenne. Le dispositif médical doit, par ailleurs, satisfaire les exigences des normes libanaises quand elles existent." Translation: "To obtain authorisation to place on the Lebanese market, the medical device must conform to at least one of the regulations in force in the following countries: Canada, Australia, Japan, United States, member states of the European Union. The medical device must, moreover, satisfy the requirements of Lebanese standards where they exist."
Prior approval / evidence record
A registration application must be accompanied by at least one of a closed menu of conformity documents: the US FDA approval (510(k) or PMA) or an FDA certificate for foreign governments; a CE marking certificate issued by a notified body plus the manufacturer's declaration of conformity; a safety certificate issued by a competent authority of Australia, Canada or Japan or other IMDRF countries; a certificate of conformity to Lebanese standards issued by the Industrial Research Institute; or — for products originating outside the EU, USA, Canada, Australia and Japan — an ISO 13485 quality-system certificate. A manufacturer's authorisation for the local distributor is required in all cases.
US FDA 510(k)/PMA and FDA certificate for foreign governments; EU CE marking certificate plus declaration of conformity; safety certificates of Australia TGA, Health Canada, Japan and other IMDRF member authorities; Lebanese IRI certificate
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Effective from 2013-11-01
Source language French. The excerpt is the contiguous run at the head of the list; the list continues on the next page, past a running header, with the CE and IMDRF bullets, quoted here separately: "o Certificat de marquage CE délivré par un organisme notifié (nom et numéro de l'organisme notifié doivent figurer d'une façon claire) ainsi que la déclaration de conformité faite par le fabricant. o Certificat garantissant la sécurité du dispositif délivré par l'une des autorités compétentes des pays suivants: Australie, Canada ou Japon et autres pays de l'IMDRF. o Certificat de conformité aux normes libanaises délivré par l'institut de recherche industriel (IRI) le cas échéant." Translation of the excerpt: "The registration application must be accompanied by at least one of the following documents: the approval of the US FDA administration (510(k) or PMA certificate); a US FDA certificate for foreign governments." Translation of the continuation: "a CE marking certificate issued by a notified body (notified body name and number must appear clearly) together with the declaration of conformity made by the manufacturer; a certificate guaranteeing the safety of the device issued by one of the competent authorities of the following countries: Australia, Canada or Japan and other IMDRF countries; a certificate of conformity to Lebanese standards issued by the industrial research institute (IRI), where applicable."
Prior approval / evidence record
US FDA (510(k)/PMA approval or approval letter), European Union (conformity certificate issued by the manufacturer and by EU-notified bodies), Swiss, Australian, Canadian or Japanese competent health authorities (conformity certificate)
Yes
Accepted and in practice required for an implantable device: Decision 455/1 Art. Six lists them as the conformity documents that go into the registration file — a European-standards certificate from the manufacturer and EU-notified bodies, an FDA marketing approval or approval letter, or a conformity certificate from the health authorities of Switzerland, Australia, Canada or Japan — and Decision 1506/1 Art. Four requires a GHTF/IMDRF free-sale certificate on top. The Ministry's service records for sterile instruments and laboratory reagents require FDA evidence for US-origin goods and CE evidence for European ones. The benefit is documentary, not a shortened clock: none of the instruments publishes an abbreviated examination period, and the registration certificate is still issued on the Health Technology Unit's advice to the Minister.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
geo:lie
EU CE under MDR/IVDR
Single Market Validity
direct
Product Marketing
Yes
No
No
Effective from 2021-05-26
Prior approval / evidence record
geo:ltu
EU CE under MDR/IVDR
Single Market Validity
direct
Product Marketing
Yes
No
No
HSL Art. 59-1(1) permits on the Lithuanian market only devices conforming to Regulation (EU) 2017/745 (or, for IVDs, the technical regulation later replaced by references to Regulation (EU) 2017/746); national law adds only registration/notification, language and vigilance duties — it creates no separate national approval.
Prior approval / evidence record
geo:lux
EU CE under MDR/IVDR
Single Market Validity
direct
Product Marketing
Yes
No
No
Confirmed on the Luxembourg CA website; national conditions (registration, language, vigilance) still apply.
Prior approval / evidence record
CE Mark (EU MDR)
Yes
Usable as supporting technical evidence. Administrative Regulation 11/2026 sets the 5, 70 and 100 working-day periods by class, not by origin.
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
Special-access-type authorisations are not eligible for the verification route, including US FDA EUA / Expanded Access / HDE, EU exceptional use authorisations, UK MHRA exceptional use, Health Canada SAP / Interim Orders, Japan compassionate use and emergency regulatory pathway, TGA SAS / Authorised Prescriber / emergency exemptions, HSA Special Access Routes, and Thai FDA section 27 non-commercial exemptions.
Prior approval / evidence record
class-b
Class B
medium
Registration
30
30
working-days
official-verified
MDA/GD/0070 — registration submission guide, cl. 6.4 turnaround
https://www.mda.gov.my/index.php/documents/ukk/3766-final-medical-device-registration-submission-guide-for-conformity-assessment-by-way-of-verification-process-and-submission-of-application-in-medc-st-second-edition
2026-08-25
3
6
months
3
6
months
No
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
For Great Britain: UKCA marking; for Northern Ireland: EC certificates (and UKNI together with EC certificates) from recognised EU NB approval types qualify for the verification route.
Prior approval / evidence record
class-c
Class C
high
Registration
30
30
working-days
official-verified
MDA/GD/0070 — registration submission guide, cl. 6.4 turnaround
https://www.mda.gov.my/index.php/documents/ukk/3766-final-medical-device-registration-submission-guide-for-conformity-assessment-by-way-of-verification-process-and-submission-of-application-in-medc-st-second-edition
2026-08-25
3
6
months
3
6
months
No
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
Devices holding at least one qualifying approval from MDA-recognised authorities may use CAB conformity assessment by way of verification instead of full assessment: EU Notified Bodies (specified MDR/IVDR and legacy directive certificates), Japan MHLW (Ninsho/Shonin), Australia TGA (ARTG), Health Canada (licence), US FDA (510(k)/PMA), UK MHRA (UKCA for GB; EC/UKNI certificates for Northern Ireland), Singapore HSA (SMDR registration), Thailand FDA (Class 2-3 notified / Class 4 licensed device certificates).
Replaces the list formerly in MDA Circular Letter No. 1/2025 Annex 1; Second Edition (13 October 2025) added HSA and Thai FDA.
Prior approval / evidence record
class-d
Class D
highest
Full Registration
30
30
working-days
official-verified
MDA/GD/0070 — registration submission guide, cl. 6.4 turnaround
https://www.mda.gov.my/index.php/documents/ukk/3766-final-medical-device-registration-submission-guide-for-conformity-assessment-by-way-of-verification-process-and-submission-of-application-in-medc-st-second-edition
2026-08-25
3
6
months
3
6
months
Yes
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
EU CE Mark
Yes
Accepted as reference-country evidence supporting the conformity assessment, but the MDA publishes no shorter period for it
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
Specified EC certificates issued by EU Notified Bodies (MDR Annex IX Ch. I & III / Annex XI Part A; IVDR Annex IX Ch. I & III / Annex X + XI; and legacy 93/42/EEC, 90/385/EEC, 98/79/EC certificates) qualify for the verification route, mapped to the corresponding Malaysian class.
Prior approval / evidence record
CE marking under Regulation (EU) 2017/745 (MDR) or Regulation (EU) 2017/746 (IVDR) is not a foreign approval in Malta — it is the domestic route. A device that complies with the applicable Union Regulation may be placed on the Maltese market without any Maltese pre-market review of the device, because Member States may not refuse, prohibit or restrict the making available of a compliant device on their territory. The device does not need to be re-certified, re-registered or re-approved in Malta. Local obligations still attach to the entities and to the presentation of the device: the Maltese economic operator must register with the Malta Medicines Authority, appoint a registered Medical Device Registered Person, enter the devices in the national medical device database, and label in English or Maltese.
EU CE Marking under MDR (Regulation (EU) 2017/745) / IVDR (Regulation (EU) 2017/746)
Single Market Validity
direct
Product Marketing
No
No
Effective from 2021-05-26
The quoted free-movement clause is the Union rule that makes a CE-marked device directly placeable in Malta; the operator-side conditions listed here come from the Maltese instrument and the Authority's own guidance, and are recorded as separate facts.
Prior approval / evidence record
Vía regulatoria abreviada — ARR equivalence (COFEPRIS-04-050)
The single reliance route since the DOF Acuerdo of 18 July 2025, which took effect 30 working days after publication and abrogated every individual equivalence agreement issued between 2012 and June 2025 — the separate FDA, Swissmedic, European Commission, Health Canada, TGA and WHO prequalification acuerdos no longer exist. COFEPRIS now recognises the decision of any Reference Regulatory Authority from a country sitting on the IMDRF Management Committee, and MDSAP full membership for GMP certificates. The dossier drops to an administrative-legal section plus technical information under RIS Art. 31.
Resolution within a maximum of 30 working days
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
EU CE Mark
Yes
The European Union sits on the IMDRF Management Committee, so it became a Reference Regulatory Authority under the July 2025 Lineamientos
Resolution capped at 30 working days
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
A device that holds CE marking reaches the Moldovan market through the notification-and-registration route and not through a national conformity assessment. AMDM's Administrative Procedure of 08.09.2026 states that devices may be placed on the market, made available, put into service and used only if they have been notified and registered by the manufacturer or its authorised representative in the State Register of Medical Devices (RSDM); the applicant notifies AMDM before placing the device on the market and files the dossier electronically in the authorised representative's personal cabinet. The CE certificate substitutes the conformity-assessment step, but the national notification-and-registration step is still mandatory and is performed by AMDM as the competent authority. Because the instrument does not issue a market authorisation - the registration of CE-marked devices is expressly stated not to be the issuance of a permissive act - the Agency retains only the power to reject a dossier, not to grant or refuse a marketing authorisation on conformity grounds.
EU CE marking - a valid CE/EU certificate of conformity issued under Regulation (EU) 2017/745 (MDR) or Regulation (EU) 2017/746 (IVDR), or a legacy MDD 93/42/EEC / AIMD 90/385/EEC EC certificate
Abridged Or Recognition Route
facilitated
Product Marketing
Yes
Yes
Romanian source. Point 19 reads: 'Potrivit art. 7 alin. (2) din Legea nr. 102/2017 ... solicitantul notifică AMDM până la introducerea pe piață a dispozitivelor medicale care dețin marcajul CE'. Source page is Romanian. Excerpt reproduces the published wording verbatim with runs of whitespace collapsed to single spaces (the site's markup inserts line breaks inside sentences); no wording was altered.
Prior approval / evidence record
EU CE marking under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR)
Yes
AMDM states that medical devices bearing the CE marking are placed on the market by way of the registration procedure, so the CE marking is the conformity input to the national route and there is a dedicated notification and registration procedure for it; the Agency describes the framework introduced by Ordinul nr. Rg04-264 din 08.09.2026 as aligned with the relevant European framework, including Regulations (EU) 2017/745 and (EU) 2017/746. Moldova is an EU candidate state and not a member, the MDR is not directly applicable, and the CE marking does not remove the entry in the State Register.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
FDA 510(k)/PMA, EU CE marking, Japan PMDA, Korea MFDS, China NMPA or any other foreign device approval
No
Mongolia recognises none of them and names none of them. Art. 33.2 requires the Agency to take into account that the device has been placed on the market in its country of manufacture, Order A/136 §3.6 permits the foreign risk grade to be considered, and Annex Two §§3.9.5 and 3.10.5 require a marketing authorisation or free-sales certificate — but no authority, country or reference list appears anywhere in the Law, in Order A/206 or in Annex Two, the foreign element is evidence of origin-country market placement rather than a recognised authorisation, no clock is shortened, and the Medical Devices Council still takes the decision.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
A foreign document, or the CE mark, is directly recognised in Montenegro if it was issued by a notified body of the European Union, or if it was affixed to the device in accordance with the harmonised technical regulation of the European Union. Direct recognition is conditional on the foreign technical regulation providing at least the same level of protection of safety, health, environment and consumers as the corresponding Montenegrin technical regulation, and on the requirements the foreign conformity-assessment body has to meet not being laxer than the Montenegrin ones. A recognition decision is valid until the foreign document expires, or at most three years from its issue if no expiry is stated.
EU CE Marking issued by an EU notified body (prijavljeno tijelo) under the EU harmonised technical regulation
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Effective from 2022-08-10
Verbatim Član 6: "Inostrana isprava, odnosno CE znak se direktno priznaje u Crnoj Gori ako je izdata od strane prijavljenog tijela Evropske unije, odnosno ako je postavljen na medicinsko sredstvo u skladu sa harmonizovanim tehničkim propisom u Evropskoj uniji." Član 5 st. 1 sets the two equivalence conditions; Član 8 st. 2-3 sets validity. Translation: a foreign document, i.e. the CE mark, is directly recognised in Montenegro if issued by an EU notified body or affixed in accordance with the EU harmonised technical regulation. Source language: Montenegrin.
Prior approval / evidence record
Recognition of a conformity document and of the CE mark issued by a conformity-assessment body that has no seat in Montenegro is carried out by the Institute within the medical-device registration procedure; exceptionally, the Institute may issue a recognition decision on the request of the manufacturer or its authorised representative.
EU CE Marking / EC certificate of conformity issued by a conformity-assessment body established outside Montenegro (in practice an EU notified body)
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Effective from 2024-10-01
Verbatim: "Priznavanje isprave o usaglašenosti i CE znaka iz st. 2 i 3 ovog člana koje je izdalo tijelo za ocjenjivanje usaglašenosti koje nema sjedište u Crnoj Gori, vrši Agencija u postupku registracije medicinskog sredstva. Izuzetno od stava 4 ovog člana, Agencija može da izda rješenje o priznavanju inostrane isprave ili CE znaka i na zahtjev proizvođača, odnosno ovlašćenog predstavnika proizvođača." Translation: recognition of a conformity document and CE mark issued by a conformity-assessment body not seated in Montenegro is done by the Agency in the registration procedure; exceptionally the Agency may issue a recognition decision on the manufacturer's/authorised representative's request. Source language: Montenegrin.
Prior approval / evidence record
For a Class I device that keeps the same risk class under MDR (EU) 2017/745 and therefore needs no notified body, the Institute accepts placement on the Montenegrin market only if the device is compliant with MDR (EU) 2017/745. A declaration of conformity issued under Directives 93/42/EEC or 90/385/EEC is not considered a valid document, and such devices may not be distributed in Montenegro.
EU CE Marking under MDR (EU) 2017/745
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Effective from 2025-06-18
Verbatim: "Medicinska sredstva I klase rizika koja su klasifikovana kao medicinska sredstva I klase rizika i u skladu sa zahtjevima EU Regulative 2017/745 ... nakon 26.05.2021. godine mogu se staviti na tržište i u upotrebu na teritoriji Crne Gore samo ukoliko su usaglašena sa zahtjevima EU Regulative 2017/745. Ukoliko naprijed navedena medicinska sredstva ne posjeduju Deklaraciju o usaglašenosti koja je usklađena sa EU Regulativom 2017/745 neće moći da se distribuiraju u Crnoj Gori, a Institut Deklaracije o usaglašenosti koje su izdate u skladu sa Direktivama 93/42 EEC i 90/385 EEC ne može smatrati validnim dokumentom." Source language: Montenegrin. Notice is based on MDR Art. 120 and the Law on Medical Devices; updated 18.06.2025.
Prior approval / evidence record
For in vitro diagnostic devices that were "other IVD" under Directive 98/79/EC and are Class A under IVDR (EU) 2017/746 — i.e. needing no notified body — a declaration of conformity issued under Directive 98/79/EC is no longer a valid document after 26 May 2022 and will not be recognised by the Institute; the declaration of conformity must comply with IVDR (EU) 2017/746. Legacy IVDD certificates that were valid on 26 May 2022 and not withdrawn may keep devices on the market at the latest until 31 December 2027, subject to the IVDR Art. 110(3) conditions.
EU CE Marking under IVDR (EU) 2017/746
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Effective from 2025-06-18
Verbatim: "Nakon 26.05.2022. godine, Deklaracija o usaglašenosti izdata u skladu sa zahtjevima Direktive 98/79 EC ne može se smatrati validnim dokumentom, te takva Deklaracija neće biti priznata u postupcima koji se vode pred Institutom za ljekove i medicinska sredstva. Deklaracija o usaglašenosti mora biti u skladu sa zahtjevima Regulative EU 2017/746." and "... in vitro dijagnostičko sredstvo može biti u prometu najkasnije do 31.12.2027. godine". Source language: Montenegrin.
Prior approval / evidence record
EU CE marking under Regulation (EU) 2017/745 (MDR)
Yes
A declaration of conformity or EC certificate issued by an EU manufacturer or an EU-notified body is recognised as the conformity input in the CInMED registration procedure under the Pravilnik o priznavanju inostranih isprava i CE znaka, and it lowers the fee line for devices that would otherwise be registered without an EU conformity document. It does not remove the national registration, and CInMED no longer accepts declarations issued under the MDD/AIMD that are not aligned with Regulation (EU) 2017/745.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
An EC certificate of conformity issued under the former MDD/AIMD directives that was valid on 26 May 2021 and has not been withdrawn remains valid after the date printed on it only until 31 December 2027 for Class III, implantable Class IIb (with listed exceptions) and AIMD devices, and until 31 December 2028 for the remaining Class IIb, Class IIa and Class Is/Im devices.
EU CE Marking — legacy MDD/AIMD EC certificates (MDR Art. 120 transition)
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Effective from 2025-06-18
Verbatim: "Ukoliko je Sertifikat o usaglašenosti – EC sertifikat izdat od strane ovlašćenog tijela u skladu sa predhodno važećim direktivama važio na dan 26.05.2021. godine i nije naknadno povučen, ostaće na snazi i nakon datuma isteka navedenog na sertifikatu i to do sljedećih datuma: a. 31.12.2027. godine – za medicinska sredstva III klase rizika, IIb koja su implantabilna (izuzetak su šavovi, klipsevi, zubni ispuni, ortodontski aparati, zubne nadoknade, zavrtnji, klinovi, ploče, žice, igle, kopče i konektori), AIMD medicinska sredstva. b. 31.12.2028. godine – za medicinska sredstva IIb klase rizika koja nijesu obuhvaćena tačkom a., IIa klase rizika i I klase rizika koja se stavljaju na tržište u sterilnom stanju ili su sa mjernom funkcijom." Source language: Montenegrin.
Prior approval / evidence record
For imported medical devices the registration dossier's technical part is lighter than for locally manufactured devices: under arrêté n° 2855-15 art. 2, 1) b) the technical pieces for an imported device of any class are the manufacturer's declaration of conformity to the essential requirements (or equivalent requirements), the draft labelling and, where applicable, draft instructions for use, and a sale-model sample or prototype; the technical documentation with a conformity check-list, the corresponding standards and the internal documents relied on — a mandatory item for locally manufactured devices under art. 2, 2) b) — is not a filing item but may be requested from the establishment during the evaluation of the device's clinical data. The AMMPS checklist (footnote 5 to item 10) restates this as 'la documentation technique n'est pas obligatoire' for imported devices and adds that clinical data must be supplied for class III. This documentary lightening is keyed to the device's imported status, not to a named reference authority; for classes Is, Im, IIA, IIB and III the imported device must in any event file the origin-country competent-authority certificate (CE, FDA, CVL or equivalent), so in practice that certificate plus the declaration of conformity and, for classes IIA–III, an ISO 13485 certificate stand in for the technical file. The 120-day review clock and the national decision are unchanged.
EU CE marking certificate; US FDA attestation; or origin-country marketing authorisation / certificat de vente libre (CVL) equivalent — the certificate that made the device registrable in its origin country
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
French original footnote (5) to dossier item 10. Translation: '(5) For imported DMs: the technical documentation is not mandatory, only the clinical data have to be supplied for class III DMs'. The waiver is an administrative-practice rule on the AMMPS's official dossier form, not a provision of loi 84-12 or décret 2-14-607; it is therefore bounded to the dossier item it annotates.
Prior approval / evidence record
A medical-device registration application must include a certificate issued by the competent authority of the country of origin: an EU CE marking certificate, an 'FDA' attestation, a marketing-authorisation / free-sale certificate (CVL), or an equivalent. The item is mandatory for risk classes IIA, IIB and III and for sub-classes Is and Im of class I. It does not shorten the Moroccan review: the device is still registered nationally and the certificate sits alongside the national dossier.
EU CE marking certificate; US FDA attestation; or an origin-country marketing authorisation / certificat de vente libre (CVL) or equivalent issued by the competent authority of the country of origin
Origin Country Evidence
Evidence Only
Premarket Review
Yes
Yes
French original. Translation: '4- CE marking certificate or "FDA" attestation or marketing authorisation (CVL) or equivalent issued by the competent authorities in the country of origin (for DM belonging to risk classes IIA, IIB and III and sub-classes Is and Im of class I)'. Checklist Réf. DE ER DM/01, édition 9, date d'application 30/01/2025. The checklist is the AMMPS's own official dossier form; the same list is re-issued on each edition.
Prior approval / evidence record
EU CE marking certificate
No
Mandatory dossier item 4 for classes Is, Im, II A, II B and III, with a CE design-examination certificate additionally required for class III. It does not shorten the review: the device is still registered nationally by the AMMPS, and the AMMPS recognition framework covers medicines and vaccines only.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
CE Mark (EU MDR)
Yes
Usable as technical and QMS evidence in the import dossier. Myanmar has no Medical Device Act and DFDA publishes no recognition route, so a CE certificate carries no defined standing beyond the documents it supplies.
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
CE Mark (EU MDR)
Yes
Neither required nor rewarded. WAND is a sponsor notification rather than an assessment: Medsafe does not review the device before it goes on the database, so there is no decision for a foreign approval to influence. The certificate matters as evidence the sponsor holds behind the notification.
None — there is no review period to shorten
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
CE Mark (EU MDR)
Yes
Usable as supporting technical evidence. The NAFDAC 2025 guidelines publish no reduced period for CE-marked devices; the only shortened route is the WHO-listed-authority one.
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
EU CE marking — a certificate of EC conformity issued by a notified body
Yes
A device that holds a certificate of EC conformity follows the abridged documentation route in чл. 7 of the 151/2010 rulebook (declaration of conformity, EC certificate, EN ISO 13485 certificate, free-sale certificate, insurance policy and representation contract) instead of the full quality, safety and efficacy dossier required by чл. 8, and чл. 22 of the same rulebook ties the register entry's validity to the validity of the certificate. It does not remove the national register entry: чл. 131 of the Law still requires the device to be entered in MALMED's register, and чл. 119 ст. 3 governs the EC mark on the device. A declaration under the MDD or AIMD is not converted into a certificate under Regulation (EU) 2017/745 by this route, because North Macedonia is not an EU/EEA member state and does not apply that Regulation.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
North Macedonia recognises conformity assessment performed through institutions recognised in the European Union. A device whose conformity is assessed by a notified body recognised in the European Union is marked with the EC mark, and the Agency accepts the resulting EC certificate or the manufacturer's EC declaration of conformity in place of full quality, safety and efficacy data. Where the device holds an EC certificate the registration dossier is the short documentary set in Article 7 of the 151/10 rulebook; where it does not, Article 8 requires the full administrative dossier plus quality, safety and efficacy data and an Agency opinion on efficacy, with risk analysis for class IIb, III, AIMD and List A/B IVDs. CE marking does not by itself confer market access: the device must still be entered in the national register of medical devices by decision of the Agency.
EU CE marking — EC certificate of conformity issued by a notified body recognised in the European Union, or (for class I devices and general IVDs) the manufacturer's European EC declaration of conformity
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Macedonian. Article 118(1) states the two permitted conformity-assessment routes: 'со оцена на сообразноста преку институции препознаени во Европската унија, односно соодветно тело за оцена на сообразноста или преку тела овластени од страна на министерот за здравство'. Article 119(3): 'медицинско средство, чија сообразност со општите и посебните услови е проценето од тело за оцена на сообразноста, односно од нотифицирано тело препознаено во Европската унија, е означено со ЕC ознака.' marketAccessStrength is 'facilitated' and not 'direct' because the recognised certificate opens a shortened documentary route only; the Agency retains and exercises its own registration decision.
Prior approval / evidence record
geo:nor
EU CE under MDR/IVDR
Single Market Validity
direct
Product Marketing
Yes
No
No
CA treats Norway as part of the single EU/EEA market: registration (not approval) is the national act; MDR/IVDR are Norwegian law via the EEA Agreement (Lov om medisinsk utstyr § 1).
Regulatory reference
Product verification/validation section accepts the origin-jurisdiction certificate: for EU-route devices CE/EC certificate, full quality assurance or design examination certificate (Class D adds TSE-free certificate if biological); for US-route devices 510(k) or PMA (Class D adds AATB certificate if from US and biological).
GD5 mirrors this for IVDs (CE certificate, Full/Production Quality Assurance, Type Examination; US route PMA/510K).
Prior approval / evidence record
CE Mark (EU MDR)
Yes
A conformity certificate and a certificate of free sale from the country of origin are what the dossier is built on. The published service period does not change with origin.
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
The device's risk classification should be according to the jurisdiction of the country of origin; the application must state the regulatory jurisdiction the device follows: KSA (MDMA), USA, EU, Canada, Australia, Japan, or Others.
Presentation slide states 'Risk Classification ( It should be according to the country of origin jurisdiction)'.
Regulatory reference
Rule 67 names the reference countries and schemes whose market authorisations DRAP relies on: USA, Japan, Australia, Canada, Austria, Belgium, Denmark, France, Germany, Ireland, Italy, Netherlands, Norway, Spain, Sweden, Switzerland and United Kingdom, or devices pre-qualified by the World Health Organization, or CE marked by conformity assessment bodies (CABs) notified in the NANDO database under the relevant European directive for medical devices, subject to evidence and supporting documents.
Effective from 2018-01-16
Regulatory reference
Under rules 15(2) and 15(3), devices registered by the authorities of the rule 67 countries are exempt from inspection of manufacturing units abroad irrespective of where the manufacturing unit is located, and devices pre-qualified by the WHO or CE marked by NANDO-notified conformity assessment bodies are likewise exempt from foreign inspection, subject to evidence and supporting documents.
Effective from 2018-01-16
Prior approval / evidence record
CE Mark (EU MDR)
Yes
Free-sale certificate and ISO 13485 evidence satisfy the technical-criterion documentary requirements
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
A device that has no Paraguayan sanitary registration may be imported for compassionate use where it has been authorised by a foreign reference regulatory agency included in the annual official list under Ley N° 7256/2024, and is required to treat a patient or group of patients urgently as determined by the treating specialist or the MSPBS. The route is an import authorisation, not a registration.
Authorisation by a foreign reference regulatory agency included in the Listado Anual Oficial under Ley N° 7256/2024 (2026 list: US FDA, EU Commission/EMA, Japan MHLW/PMDA, Korea MFDS, ANMAT, ANVISA, ISP and others)
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Effective from 2025-06-30
Source language: Spanish. Translation: 'Medicines or medical devices Registered by a Regulatory Authority: Medicines or medical devices that have been authorised by a foreign reference regulatory agency included in the official annual list pursuant to Law N° 7256/2024 or its updates, that do not have a sanitary registration issued by DINAVISA and that are required to treat a patient or group of patients urgently, determined by the treating specialist physician, or the Ministry of Public Health and Social Welfare.' Art. 12 (OCR renders it 'Artículo 129') sets the resolution in force from 30 June 2025.
Prior approval / evidence record
For IVDs, DINAVISA decides within 30 business days for products manufactured nationally or in a country of Annex I, within 45 business days for products manufactured outside Annex I but registered and commercialised in an Annex I country (which must additionally file the foreign registration certificate and free-sale certificate), and within 120 business days for other imports. Annex I names high-surveillance and adequate-surveillance authorities and the full MERCOSUR members; the United States and Japan are on it and Korea is not.
Sanitary registration and free-sale certificate in force in an Annex I country — high-surveillance authorities (Germany, Austria, Belgium, Canada, Denmark, Spain, United States, France, Israel, Italy, Japan, Netherlands, United Kingdom, Sweden, Switzerland) or adequate-surveillance authorities (Australia, Chile, Cuba, Finland, Hungary, Ireland, Luxembourg, Mexico, Norway, New Zealand); Annex I also lists full MERCOSUR members (Argentina, Brazil, Paraguay, Uruguay) and PAHO/WHO reference authorities
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Source language: Spanish. Translation of the quoted Annex I heading and entries: 'Countries with High and Adequate Sanitary Surveillance Authorities (Law 3283/07 Article 11)' / 'Countries with high sanitary surveillance regulatory authorities: Germany, Austria, Belgium, Canada, Denmark, Spain, United States, France, Israel, Italy, Japan, Netherlands, United Kingdom, Sweden and Switzerland.' / 'Full MERCOSUR members: Argentina, Brazil, Paraguay and Uruguay.' The excerpt is taken from the resolution's own Annex I; Art. 6 supplies the 30- and 45-business-day clocks.
Prior approval / evidence record
The Listado Anual Oficial that Res. 226/2024 Art. 8(a) incorporates by reference does name US FDA, the European Commission (DG SANTE)/EMA, Japan MHLW/PMDA and Korea MFDS — but every entry's stated 'Alcance' is medicamentos and/or vacunas. No listed authority, and no separate list entry, is scoped to dispositivos médicos, so on the published instrument the simplified device route is not anchored to any device-scoped reference authority.
none
International Listing
none
Premarket Review
Yes
Yes
Effective from 2026-05-01
Source language: Spanish. Translation of the quoted entries: 'United States: US FDA. Scope: Medicines and vaccines.' / 'European Commission (DG SANTE); European Medicines Agency (EMA); National Regulatory Authorities. Scope: Medicines and vaccines.' / 'Republic of Korea: Ministry of Food and Drug Safety (MFDS). Scope: Medicines and vaccines.' / 'Japan: Ministry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices Agency (MHLW/PMDA). Scope: Medicines' and a second Japan entry 'Pharmaceuticals and Medical Devices Agency (PMDA). Scope: Vaccines'. The resolution is dated 'de mayo de 2026'; the day glyph is illegible in the scan and is not reproduced. effectiveFrom is the month of signature only.
Prior approval / evidence record
A class II, III or IV medical device already authorised by an authority of a country on the Listado Anual Oficial (emitted under Ley N° 7256/2024 Art. 3) or by an authority with a published bilateral recognition agreement enters the 'Proceso simplificado de Registro Sanitario' instead of full integral analysis. The applicant still files every Art. 6 requirement and still needs a Paraguayan registration, but DINAVISA re-examines only items b), c), d), g) and h) of Art. 6 rather than the whole dossier.
Any marketing authorisation issued by an authority of a country on the Listado Anual Oficial — the 2026 list (Resolución DINAVISA N° 182/2026) names US FDA, European Commission (DG SANTE)/EMA and EU national authorities, Japan MHLW/PMDA, Korea MFDS, Singapore HSA, Indonesia BPOM, ANMAT, ANVISA and ISP — each entry stated as scoped to medicamentos and/or vacunas
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Effective from 2024-09-16
Source language: Spanish. Translation: 'Applications for registration of products classified by DINAVISA as class II, III and IV medical devices that are authorised by authorities of the countries on the Annual Official List emitted in Resolución DINAVISA N° 148/2024 and its updates, as well as those Regulatory Authorities with which bilateral agreements for the recognition of authorisations exist, which so provide, published on the DINAVISA website, shall be subject to the simplified Sanitary Registration Process.' OCR of the two-column official PDF was normalised: 'Clase l' rendered as 'Clase II' and 'N*148/2024' as 'N°148/2024'.
Prior approval / evidence record
EU CE marking / EU notified body certificate
No
The European Commission (DG SANTE), EMA and EU national authorities appear in the Listado Anual Oficial with an Alcance of medicamentos and vacunas; a CE certificate is accepted as quality-system evidence under Art. 6(a) but does not replace Paraguayan registration.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
Class II, III and IV in-vitro diagnostic products already authorised and commercialised in countries regulated by PAHO/WHO reference regulatory authorities, by authorities of IMDRF Management Committee member countries, or by authorities with bilateral agreements with DINAVISA enter the Proceso Simplificado de Registro Sanitario (PSR). DINAVISA has 15 business days to validate and decide, and approval follows by positive silence if no report is issued.
PAHO/WHO reference regulatory authorities; authorities of IMDRF Management Committee member countries (the IMDRF committee includes US FDA, EU, Japan PMDA/MHLW, Health Canada, TGA, ANVISA, China NMPA, Korea MFDS, Singapore HSA and UK MHRA); authorities with bilateral agreements with DINAVISA
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Effective from 2024-01-30
Source language: Spanish. Translation of the operative part of Art. 2: 'Applications for sanitary registration of In Vitro Diagnostic Products ... that are authorised and commercialised in countries regulated by: PAHO/WHO Reference Regulatory Authorities; Regulatory Authorities of member countries of the Committee of the International Medical Device Regulators Forum - IMDRF; Regulatory Authorities with which bilateral agreements with DINAVISA exist, shall be subject to the Simplified Sanitary Registration Process (PSR).' and 'DINAVISA shall have a term of 15 (fifteen) business days to validate the required documentation and decide thereon. Once the term has elapsed with no report from DINAVISA, the application shall be approved.' Article numbering confirmed by reading the page image of the official PDF.
Prior approval / evidence record
class-iii
Class III
high
Registration
66
66
working-days
official-verified
DIGEMID TUPA (D.S. 011-2026-SA) — device procedure attention periods
https://cdn.www.gob.pe/uploads/document/file/10349703/8409411-tupa-parte-2.pdf
2026-08-25
6
12
months
4
7
months
No
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
class-iv
Class IV
highest
Full Registration
66
66
working-days
official-verified
DIGEMID TUPA (D.S. 011-2026-SA) — device procedure attention periods
https://cdn.www.gob.pe/uploads/document/file/10349703/8409411-tupa-parte-2.pdf
2026-08-25
8
15
months
5
8
months
Yes
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
For free-sale certificate and related evidence purposes, the high-vigilance countries are France, Netherlands, UK, USA, Canada, Japan, Switzerland, Germany, Spain, Australia, Denmark, Italy, Norway, Belgium and Sweden.
D.S. 018-2019-SA subsequently added Austria to this list (as shown on DIGEMID's normas-legales repository).
Prior approval / evidence record
class-ii
Class II
medium
Registration
44
44
working-days
official-verified
DIGEMID TUPA (D.S. 011-2026-SA) — device procedure attention periods
https://cdn.www.gob.pe/uploads/document/file/10349703/8409411-tupa-parte-2.pdf
2026-08-25
4
8
months
3
5
months
No
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
EU CE Mark
Yes
Accepted where the certificate of free sale comes from one of the eleven EU or EFTA states on the high-surveillance list. A CE certificate from a notified body in a member state outside that list does not by itself carry the same standing.
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
País de Alta Vigilancia Sanitaria (art. 9 D.S. 016-2011-SA): United States, Canada, Japan, Australia, Switzerland, South Korea, United Kingdom, Germany, France, Netherlands, Spain, Italy, Belgium, Portugal, Ireland, Austria, Hungary, Denmark, Norway, Sweden
Yes
The Peruvian route to relying on a foreign approval is documentary, not procedural. A certificate of free sale or a GMP certificate issued by a high-surveillance authority is accepted directly, and if the issuing authority appears on the Resolución Directoral 169-2014-DIGEMID list the document does not need an apostille. Everything else still goes through DIGEMID certification.
None published — the TUPA period is set by class, not by origin
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
EU CE Mark
Yes
Supports the Certificate of Free Sale and the CSDT technical evidence, but the Philippine FDA publishes no shorter period for it
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
class-d
Class D
highest
Full Registration
180
180
days
official-verified
FDA Philippines AO 2018-0002 — statutory evaluation clocks
https://elibrary.judiciary.gov.ph/thebookshelf/showdocs/10/89924
2026-08-25
9
18
months
6
10
months
Yes
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
class-b
Class B
medium
Registration
80
80
working-days
official-verified
FDA Philippines Citizen’s Charter 2025 — CDRRHR total processing times
https://www.fda.gov.ph/citizen-charter-cdrrhr-2025/
2026-08-25
4
9
months
3
5
months
No
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
class-c
Class C
high
Registration
180
180
days
official-verified
FDA Philippines AO 2018-0002 — statutory evaluation clocks
https://elibrary.judiciary.gov.ph/thebookshelf/showdocs/10/89924
2026-08-25
6
12
months
4
7
months
No
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
geo:pol
EU CE under MDR/IVDR
Single Market Validity
direct
Product Marketing
Yes
No
No
The Ustawa z dnia 7 kwietnia 2022 r. o wyrobach medycznych is the Polish implementing act: it designates URPL, sets the Polish language rules, the national registers and the advertising regime. It adds duties around a CE-marked device rather than conditioning its market access on a Polish decision.
Prior approval / evidence record
geo:prt
EU CE under MDR/IVDR
Single Market Validity
direct
Product Marketing
Yes
No
No
Decreto-Lei n.º 29/2024, as amended by Decreto-Lei n.º 118/2025, executes MDR in Portugal and gives INFARMED its mandate, the notification regimes and the language rules. Registration duties for IVDs additionally survive under the directive-era Decreto-Lei n.º 189/2000.
Regulatory reference
IMD registration requires notarized CE or FDA certificates from the country of origin listing the reference numbers of the devices being registered.
Regulatory reference
For MoPH technical evaluation of medical equipment in a healthcare facility, each device must be supported by an original FDA/CE certification or an equivalent approval.
Prior approval / evidence record
geo:rou
EU CE under MDR/IVDR
Single Market Validity
direct
Product Marketing
Yes
No
No
Ordonanța de urgență nr. 46/2021 implements MDR and OUG nr. 137/2022 implements IVDR. Both designate the competent authority, set the Romanian language rules and require entry in the national database; neither creates a Romanian conformity decision.
Prior approval / evidence record
CE Mark (EU MDR)
Yes
Technical and QMS documentation can be reused, but the EAEU route requires its own expertise at VNIIMT and its own Russian-language dossier. Roszdravnadzor publishes no reduced period for CE-marked devices.
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
Rwanda FDA operates an abridged assessment procedure for medical device registration. Abridged assessment is defined as a limited independent assessment of specific parts of the dossier, taking into account prior assessment (dossier review and/or independent performance evaluation) and inspection outcomes from WHO prequalification or any National Regulatory Authority the Authority deems competent. The cover letter template for an abridged application (Appendix 1 of DHT/GDL/024) requires the applicant to confirm that the product dossier submitted is the same in all aspects as the product registered with the relevant SRA, WHO PQ and EAC. The statutory basis is Article 16 of the device registration regulations, which allows the Authority to rely on regulatory decisions of regional, international and other stringent regulatory authorities for product market authorisation. For devices under abridged assessment, QMS compliance of the manufacturing site is confirmed by desk review rather than an on-site inspection, although the Authority may still conduct an on-site inspection if necessary.
US FDA; EU CE marking under MDR 2017/745 / IVDR 2017/746 or the predecessor directives; Japan PMDA/MHLW; Korea MFDS; and any other authority the Rwanda FDA deems competent under the SRA concept, where the product is registered with that authority as an SRA; WHO Prequalification; EAC registration
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Effective from 2025-11-01
Verbatim (Glossary 2): "'Abridged assessment' a limited independent assessment of specific parts of the dossier, or regulatory submission of data for suitability of use under local conditions and regulatory requirements, taking into account prior assessment (including dossier review and/or independent performance evaluation) and inspection outcomes from WHO prequalification or any National Regulatory Authority (NRA) deemed by the Authority as competent to inform the latter in its decision." Verbatim (application form): 'I confirm that the Product Dossier information submitted is the same in all aspects as the product registered with the relevant SRA, WHO PQ and EAC (Only for Abridged Applications)'.
Prior approval / evidence record
FDA 510(k) / PMA, EU CE marking, Japan PMDA, Korea MFDS
Yes
Handled through the SRA concept rather than by a substitute approval; the Rwandan registration and certificate are still issued by Rwanda FDA and the reliance decision is discretionary.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
Rwanda FDA's Guidelines on Reliance for Regulatory Decision-Making (ODG/RAHC/GDL/001 Rev 3) apply to all types of medical products and to registration, marketing authorisation, GMP/GCP inspections, clinical trials, vigilance, post-marketing surveillance and laboratory testing. For marketing authorisation the Authority may apply reliance where the product has been evaluated and listed as a WHO Prequalified Product (including the WHO PQ collaborative registration procedure), approved by stringent regulatory authorities, registered by WHO Listed Authorities (WLAs) or WHO transitional Listed Authorities (category B), recommended by continental or regional harmonisation initiatives such as EMA and the East African Community through joint dossier assessments, or registered by an ML3 functioning regulatory authority holding a memorandum of understanding with Rwanda FDA. The reliance pathway for marketing authorisation is stated to take 90 working days excluding clock stops.
WHO Prequalification and the WHO PQ Collaborative Registration Procedure; Stringent Regulatory Authorities; WHO Listed Authorities and WHO transitional Listed Authorities (category B); EMA and EAC joint dossier assessments; ML3 authorities holding an MoU with Rwanda FDA
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Effective from 2024-02-14
Verbatim (5.1): 'The Authority may apply reliance procedures for granting Marketing Authorization in the following situations: a) The product should have been evaluated and listed as a WHO Prequalified Product including the WHO PQ collaborative registration procedure between WHO and the Authority. b) The product should have been approved by Stringent regulatory authorities. c) The product should have been registered by a WHO listed Authorities (WLAs) and WHO transitional Listed Authorities (B category). d) The product should have been recommended by Continental and Regional regulatory harmonization initiatives and networks such as EMA and EAC, through the Joint Dossier Assessments e) The product should have been registered by ML3 functioning regulatory Authorities having Memorandum of Understanding (MoU) with Rwanda FDA.' Verbatim (Scope): 'These Guidelines cover reliance activities regarding all types of medical products and regulatory activities using reliance approaches.'
Prior approval / evidence record
EU CE Mark
No
GHTF route canceled Jan 2022
None
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
EU CE marking / notified-body certificate
No
Not a substitute for ARP registration, but the technical file, the déclaration de conformité and the test reports behind a CE certificate are the same evidence the ARP requires for the enregistrement dossier.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
CE Mark (EU MDR)
Yes
ALIMS registration is EU-aligned and rests on the CE certificate, but the 30-day decision period in Art. 52 of the Law on Medical Devices is the same whatever the origin.
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
An ALIMS decision recognising a foreign document or CE mark is valid until the expiry of the validity term set in the foreign document; if the foreign document sets no expiry term, the recognition decision is valid at most three years from issuance. Recognition is refused if the foreign document does not meet the equivalence conditions of bylaw Art. 4.
Consolidated bylaw text
Prior approval / evidence record
class-c
Class C
high
IBR/Expedited/Full Route
0
220
working-days
official-verified
HSA fees and turnaround time for medical devices
https://www.hsa.gov.sg/medical-devices/fees/
2026-03-26
2026-08-13
6
12
months
0.03
0.03
months
No
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
class-b
Class B
medium
IBR/Expedited/Full Route
0
160
working-days
official-verified
HSA fees and turnaround time for medical devices
https://www.hsa.gov.sg/medical-devices/fees/
2026-03-26
2026-08-13
3
9
months
0.03
0.03
months
No
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
Two reference approvals (any two of US FDA, EU Notified Body, Health Canada, Australia TGA, Japan MHLW)
Yes
At Class B this is the IBR trigger and registration is granted on submission. At Class C and D it is the ECR-2 or EDR trigger.
Class B immediate against 160 working days; Class C 120 against 220; Class D 180 against 310
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
EU CE Mark
Yes
Qualifies for the abridged route on the same terms, but only via the specific EC certificate routes HSA lists — a self-declared Class I CE mark does not count, and neither does a reference-agency Class I or Class II exempt classification.
Class B 100 working days against 160; Class C 160 against 220; Class D 220 against 310
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
EU notified body certificates qualify as reference approvals: MDR Annex IX/XI-A, IVDR Annex IX, and legacy directive certificates (93/42/EEC, 98/79/EC) as specified on HSA's registration overview page.
Confirms baseline reliance edge; certificate annexes quoted from overview page.
Prior approval / evidence record
class-d
Class D
highest
IBR/Expedited/Full Route
180
310
working-days
official-verified
HSA fees and turnaround time for medical devices
https://www.hsa.gov.sg/medical-devices/fees/
2026-03-26
2026-08-13
9
18
months
6
12
months
Yes
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
geo:svk
EU CE under MDR/IVDR
Single Market Validity
direct
Product Marketing
Yes
No
No
Zákon č. 362/2011 Z. z. is the Slovak law of record, with §§ 110, 110a and 110b carrying the device provisions ŠÚKL applies. The national step is notification to ŠÚKL, not approval.
Prior approval / evidence record
geo:svn
EU CE under MDR/IVDR
Single Market Validity
direct
Product Marketing
Yes
No
No
The Zakon o medicinskih pripomočkih (ZMedPri-1), Uradni list RS 40/25, in force since 19 June 2025, is the Slovenian implementation act for MDR, IVDR and Regulation 2022/123. It sets competent authorities, language rules, registrations and supervision.
Prior approval / evidence record
CE Mark (EU MDR)
Yes
A CE certificate is the technical dossier and QMS evidence SAHPRA works from on the reliance pathways.
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
EU CE Mark
No
No direct recognition
None
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
geo:esp
EU CE under MDR/IVDR
Single Market Validity
direct
Product Marketing
Yes
No
No
Real Decreto 192/2023 regulates devices and Real Decreto 942/2025 regulates IVDs. Spain layers two national duties on a CE-marked device that are easy to miss: entry in the Registro de comercialización (RECOPS) and a prior operating licence for the establishment placing the device on the market.
Regulatory reference
For general medical devices, registrations from USA, UK, Australia, Canada, Japan, Norway, Switzerland and all EU member countries are considered under the reliance pathway; for IVD medical devices the same list applies plus Singapore.
Prior approval / evidence record
geo:swe
EU CE under MDR/IVDR
Single Market Validity
direct
Product Marketing
Yes
No
No
Confirmed with a national official source: approvals from other geographic regions cannot replace CE marking for Sweden.
Prior approval / evidence record
geo:che
EU CE under MDR/IVDR
Unilateral Recognition
Direct With Local Obligations
Product Marketing
No
No
Switzerland unilaterally recognises the CE label: a device lawfully CE-marked under the EU system may be placed on the Swiss market without a separate Swiss conformity-assessment or authorisation step, subject to local obligations (CH-REP, actor and device registration, languages, vigilance, market surveillance).
Recognition is unilateral following the lapse of the mutual recognition agreement; Swissmedic states it 'follows what is specified for the European Union (EU) system of compliance assessment and certification'.
Prior approval / evidence record
EU CE Mark (MDR)
Yes
Full recognition - immediate Swiss market access
Immediate
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
Unilateral recognition of EU/EEA certificates
The device chapter of the EU-Switzerland MRA has not applied since 26 May 2021 and has not been restored; Switzerland instead recognises EU/EEA notified-body certificates one-way under MepV Art. 25(4), which is why a CH-REP and Swiss labelling are still required
No second conformity assessment
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Regulatory reference
Certificates issued by bodies designated under EU law and established in an EU or EEA state that are not recognised through an international agreement are treated as equivalent to certificates of Swiss designated bodies, provided it is credibly demonstrated that the applied conformity assessment procedures satisfy Swiss requirements and the body has qualifications equivalent to those required in Switzerland.
Also underpins the legacy-transition option to apply to an EU/EEA notified body (Arts. 100-101 MedDO).
Prior approval / evidence record
class-i
Class I
low
Self-declaration (no conformity assessment body)
0
0
days
official-verified
Medizinprodukteverordnung (MepV, SR 812.213), Stand 1. Juli 2026 — Art. 23 conformity assessment by reference to EU MDR, Art. 25(4) equivalence of EU/EEA notified-body certificates
https://www.fedlex.admin.ch/eli/cc/2020/552/de
2026-07-01
2026-08-29
3
5
months
1
2
months
No
No
No
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
EU CE Mark (MDD)
Yes
Recognized until certificate expiry
Immediate
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
EU CE Mark Recognition
Full recognition of EU CE marked devices until 2028
Immediate market access
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
QSD Abbreviated Pathway
Abbreviated QMS review for USA/EU/Japan manufacturers
2-3 months faster
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
class-ii
Class II
medium
Registration
140
140
days
official-verified
TFDA people’s application handling-period table (FDA器字第1151604804號) — Class I 80, Class II 140, Class III 200 calendar days
https://www.fda.gov.tw/tc/newsContent.aspx?cid=3&id=31695
2026-08-17
2026-08-29
9
14
months
6
9
months
No
Yes
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
EU CE Mark
Yes
Fast-track pathway
2-4 months
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
class-iii
Class III
highest
Registration with clinical data
200
200
days
official-verified
TFDA people’s application handling-period table (FDA器字第1151604804號) — Class I 80, Class II 140, Class III 200 calendar days
https://www.fda.gov.tw/tc/newsContent.aspx?cid=3&id=31695
2026-08-17
2026-08-29
12
18
months
8
11
months
Yes
Yes
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
CE Mark (EU MDR)
Yes
Usable as supporting technical evidence. The TMDA Compendium sets one 20-45 working-day service standard per class and publishes no origin-based reduction.
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
geo:tha
EU CE under MDR/IVDR
Abridged Review
facilitated
Product Marketing
Yes
Yes
12
Page states the history condition verbatim: อย่างน้อย 1 ปีขึ้นไป.
Prior approval / evidence record
EU CE Mark
Yes
Supports the Certificate of Free Sale and the CSDT technical evidence, but the Thai FDA publishes no shorter period for it
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
class-3
Class 3
high
Registration
250
250
days
official-verified
Thailand Ministerial Regulation B.E. 2563 — statutory review clocks (ข้อ ๕-๖)
https://medical.fda.moph.go.th/media.php?id=478924090456023040&name=กฏกระทรวงการแจ้งรายการละเอียดและการการออกใบรับแจ้งรายการละเอียดผลิตหรือนำเข้าเครื่องมือแพทย์ พ.ศ. 2563.pdf
2026-08-25
4
5
months
No
Yes
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
class-2
Class 2
medium
Registration
250
250
days
official-verified
Thailand Ministerial Regulation B.E. 2563 — statutory review clocks (ข้อ ๕-๖)
https://medical.fda.moph.go.th/media.php?id=478924090456023040&name=กฏกระทรวงการแจ้งรายการละเอียดและการการออกใบรับแจ้งรายการละเอียดผลิตหรือนำเข้าเครื่องมือแพทย์ พ.ศ. 2563.pdf
2026-08-25
4
5
months
No
Yes
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
class-4
Class 4
highest
Full Registration
300
300
days
official-verified
Thailand Ministerial Regulation B.E. 2563 — statutory review clocks (ข้อ ๕-๖)
https://medical.fda.moph.go.th/media.php?id=478924090456023040&name=กฏกระทรวงการแจ้งรายการละเอียดและการการออกใบรับแจ้งรายการละเอียดผลิตหรือนำเข้าเครื่องมือแพทย์ พ.ศ. 2563.pdf
2026-08-25
4
5
months
Yes
Yes
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
For a device conforming to European Union legislation, ANMPS accepts the EU conformity certificate as the conformity evidence in its device technical dossier: for class I devices a valid ISO 13485 certificate issued by a certification body, and for every other class a CE certificate of conformity issued under Regulation (EU) 2017/745 according to the device's risk class. Only CE certificates issued by notified bodies notified to the European Commission (listed on NANDO) are accepted. Where no valid MDR certificate exists, ANMPS accepts instead the written agreement with a notified body under Annex VII, section 4.3, second paragraph of Regulation (EU) 2017/745, or a notified-body confirmation letter under Regulation (EU) 2023/607 — Tunisia expressly tracks the EU's own MDR-transition extension.
EU CE marking — CE certificate of conformity under Regulation (EU) 2017/745 issued by a NANDO-listed notified body; or a valid ISO 13485 certificate for class I devices; or, where no valid MDR certificate exists, an Annex VII §4.3 written agreement with a notified body or a notified-body letter under Regulation (EU) 2023/607
Origin Country Evidence
Evidence Only
Premarket Review
Yes
Yes
Effective from 2026-03-02
French original. Translation: 'f.1. The European Community conformity certificate (CE), for devices conforming to European legislation — For class I devices: a valid ISO 13485 certificate of conformity issued by a certification body. — For all other devices: a CE certificate of conformity according to the risk class of the device and the requirements of Regulation 2017/745. Note: only CE certificates issued by notified bodies notified to the European Commission (listed on the NANDO site) will be accepted.' and 'f.2. Case of absence of a valid CE certificate of conformity under MDR — A copy of the written agreement in accordance with Annex VII, section 4.3, second paragraph, of Regulation (EU) 745/2017 signed between the manufacturer and the notified body, or a letter from the notified body confirming the status of a formal application, the written agreement between the manufacturer and the notified body and the appropriate surveillance under Regulation (EU) 2023/607.' The document is dated 26.02.2026 with application from 02/03/2026. Retrieved as full raw text; portail.anmps.tn refuses direct TCP connections from this network (curl and WebFetch both return connection-refused / HTTP 000 on ports 80 and 443), so the document was read through a text-extraction fetch of the same URL.
Prior approval / evidence record
EU CE certificate of conformity (Regulation (EU) 2017/745, NANDO-listed notified body)
No
Mandatory dossier evidence for every class except class I, and the regime the ANMPS guide names as the benchmark; where no valid MDR certificate exists the agency accepts an Annex VII §4.3 written agreement with a notified body or a notified-body letter under Regulation (EU) 2023/607. It does not replace the Tunisian AMC, which the ANMPS issues after its own avis technique or analyse.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
CE Mark (EU MDR)
Yes
The Tıbbi Cihaz Yönetmeliği transposes EU MDR essentially verbatim, so a CE certificate from an EU notified body is directly usable for the ÜTS filing and there is no separate Turkish product approval to shorten. One divergence matters going forward: from 25 February 2027 the EU notified body issuing that certificate is capped at 170 days by Regulation (EU) 2026/977, while a Turkish-designated body issuing the same certificate stays uncapped because Turkey has not transposed it.
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
geo:tur
EU CE under MDR/IVDR
Customs Union Free Circulation
Direct With Local Obligations
Product Marketing
No
No
Confirmed from the Turkish regulation itself: devices must bear the CE mark (Madde 20) and importers/distributors verify CE marking and the EU declaration of conformity (Madde 13(2)/14).
Regulatory reference
TİTCK duyuru 2026/KKB-1 (04.05.2026, Medical Device Registration and Coordination Department) announces that use of the EUDAMED database system has become mandatory and sets out the effect on UTS certificate and device registration processes.
Announcement verified on the official TİTCK activity-area page; the duyuru detail page itself was not reachable (404) from the research environment.
Regulatory reference
Devices conforming to harmonized standards (or relevant sections) whose reference numbers have been published in the Official Journal of the European Union are presumed to conform to the Regulation's requirements covered by those standards.
Prior approval / evidence record
EU CE Mark
Yes
An EC certificate is one of the accepted conformity certificates for the same mandatory document slot, with an EC declaration of conformity acknowledgement required in addition.
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
Uganda treats recognised-country certification as an eligibility gate, not merely as evidence. DAR/GDL/028 s. 4.11 states that devices not certified by any of the recognised countries will be examined and may be exempted from recognised-country certification only if they are class A; for other classes the recognised-country or CE certification is a must. The recognised countries are the United States (FDA clearance/approval), Canada, Japan (MHLW clearance/approval) and Europe. For Europe the certificate required scales with class: full quality assurance / EC Type Examination Certificate for class B and C, and full quality assurance / EC Design Examination Certificate for class D, and the notified body must itself be approved by European health authorities.
US FDA clearance/approval; Canada clearance/approval; Japan MHLW clearance/approval; Europe EC quality-system certification with an EC Type Examination Certificate (class B and C) or EC Design Examination Certificate (class D) issued by a notified body approved by European health authorities
Eligibility Gate
facilitated
Premarket Review
Yes
Yes
Effective from 2020-08-14
Excerpt is a contiguous verbatim run from s. 4.11 with the class-by-class European detail joined by [...]. edgeType 'eligibility_gate' is reused from the existing vocabulary (1 prior use) rather than inventing a token: the mechanism is that recognised certification is a precondition for classes B-D, which is what that token means. marketAccessStrength is 'facilitated' rather than 'evidence_only' because holding the certificate changes which applications can be accepted at all, not just how much paperwork is filed. There is an internal tension in the source between s. 4.11 (certification is a must for classes B-D) and s. 4.12.3 (Track 3 for products with no certification to any listed quality system standard); both are recorded, and the tension is stated in conditions rather than resolved by assumption.
Prior approval / evidence record
A device already licensed in one of the IMDRF founding-member countries goes into Track 1, which NDA describes as an expedited review with shortened registration timelines whose evaluation process is abridged by the foreign approval. The applicant does not re-submit the full technical dossier: Track 1 requires a covering attestation, abbreviated product and manufacturer details, a notarized copy of the IMDRF-country licence, a Certificate of Analysis confirming compliance to an accepted quality system standard, evidence of repeat sales in the country of manufacture, product samples where practicable, and a completed submission checklist. The approval recognised is the one listed for the country in DAR/GDL/028 Table 2.
Australia: TGA GMPALS licence or CE mark; Canada: appliance licence; European Union: CE mark; Japan: MHLW appliance licence; United States: FDA 510(k) letter
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Effective from 2020-08-14
Excerpt joins the s. 4.12.1 heading with items (d) and (e) of the same list and with Table 2 verbatim, separated by [...]. NDA's Medical Devices page restates the same mechanism in its own words for the customer question: 'Foreign manufacturers entering the Ugandan market can leverage their existing approvals in recognized reference markets (Australia, Canada, European Union countries, Japan, and the United States) with expedited reviews and shortened registration timelines.' That page sentence is the supporting source's contribution and is why this is not marked source-backed-partial.
Prior approval / evidence record
Licence or approval from an IMDRF founding-member country — Australia, Canada, the European Union, Japan, the United States
Yes
Track 1: an abridged evaluation in which the foreign approval carries the technical assessment, with a much smaller submission (attestation, abbreviated product and manufacturer details, notarized copy of the licence, Certificate of Analysis to an accepted quality-system standard, evidence of repeat sales and product samples where practicable). It is an expedited review with shortened registration timelines, but NDA publishes no number for the shortening and the final decision remains NDA's.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
Recognised-country certification or CE certification — an eligibility gate for classes B, C and D
Yes
DAR/GDL/028 §4.11 makes certification from a recognised country (United States, Canada, Japan, Europe) or CE certification mandatory for classes B, C and D: devices not certified by any recognised country will be examined and may be exempted from the requirement only if they are class A. The European certificate required scales with class — full quality assurance or EC Type Examination Certificate for classes B and C, and full quality assurance or EC Design Examination Certificate for class D, from a notified body approved by European health authorities. This is a gate, not a fast track: it conditions eligibility and shortens nothing by itself.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Regulatory reference
EU MDR has applied in Northern Ireland since 26 May 2021 and EU IVDR since 26 May 2022; CE marking is required for the Northern Ireland market, with the UKNI indication additionally required where a UK notified body performed the mandatory conformity assessment. GB-based manufacturers selling into Northern Ireland must appoint an EU or Northern Ireland-based authorised representative, and NI devices must be registered with MHRA (custom-made devices within 28 days of being made available on the NI market).
Effective from 2021-05-26
Regulatory reference
CE-marked general medical devices certified under the MDD/AIMDD can be placed on the Great Britain market up until the sooner of certificate expiry or 30 June 2028; CE-marked IVDs under the IVDD are accepted up until the sooner of certificate expiry or 30 June 2030, with MHRA registration and (for overseas manufacturers) a UK responsible person.
· Effective until 2030-06-30
Refines baseline '2028-06-30 or 2030-06-30 depending on CE route': MDD/AIMDD = 2028-06-30, IVDD = 2030-06-30.
Prior approval / evidence record
International Reliance (draft legislation, not in force)
Stand-alone route giving a Certificate of International Reliance to devices already authorised by the FDA, Health Canada or the TGA, without UKCA marking; the EU is deliberately excluded pending the separate CE-recognition decision
Not quantified — the draft fixes no review period
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Regulatory reference
Devices CE marked under EU Regulation 2017/745 (MDR) or 2017/746 (IVDR) can be placed on the Great Britain market up until 30 June 2030, with MHRA registration and (for overseas manufacturers) a UK responsible person.
· Effective until 2030-06-30
gov.uk consultation on indefinite recognition of CE-marked devices ran Feb/Mar 2026 (policy paper).
Prior approval / evidence record
CE Mark Recognition (Transition)
EU CE marks accepted during transition period
Immediate market access
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
class-i
Class I
low
Self-declaration (no approved body)
0
0
days
official-verified
The Medical Devices Regulations 2002 (SI 2002/618, as amended) — reg. 16(1) and 29(1) 60-day clinical investigation notice, and the 210-day Secretary of State opinion on ancillary medicinal substances
https://www.legislation.gov.uk/uksi/2002/618
2026-08-29
0.5
1
months
2
3
weeks
No
No
No
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
EU CE Mark
Yes
Full recognition during transition (until 2027-2030)
Months → Weeks
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
CE Mark (EU MDR)
Yes
Ukraine still runs the old EU directives rather than MDR, and Law No. 1207 as amended for martial law lets a CE-marked device onto the market on that basis, so the CE certificate is the route rather than an accelerant. No provision puts a period on the conformity assessment either way.
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
CE Mark (EU MDR)
Yes
Uruguay works from the certificate of free sale and the technical dossier behind the CE certificate. The MSP period is set by the procedure, not by where the device was approved.
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
EU CE Mark
No
Clinical data can be leveraged
Indirect
Maintained reference · planning ranges remain estimates · reviewed 2026-08-25
Regulatory reference
FDA does not recognize regulatory authorizations from other countries (for example EU CE marking under MDR/IVDR): any device imported or marketed in the US must independently meet the applicable FDA requirements (registration, listing, 510(k)/PMA, QMS, labeling, US agent, MDR, inspections).
Regulatory reference
Devices registered by the following are registered in Uzbekistan by the recognition route: US FDA; EU bodies authorized to issue CE conformity certificates; EMA (EU); PMDA (Japan); MFDS (Republic of Korea); MHRA (United Kingdom). Foreign certificates are verified against the issuing regulator's official registers/website; if not verifiable through open sources they must be apostilled or consularly legalized.
Effective from 2026-02-26
WHO-prequalified IVDs registered in cooperation with WHO get a separate 60-working-day route.
Prior approval / evidence record
CE Mark (EU MDR)
Yes
Reference-jurisdiction registration is the trigger for the recognition route below; on the ordinary route the CE dossier is reused but the Annex-1 periods are unchanged.
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
class-c
Class C
high
Circulation number registration (Ministry of Health)
45
45
days
official-verified
Nghị định 98/2021/NĐ-CP on the management of medical devices (as amended by Decrees 07/2023, 96/2023, 04/2025) — Art. 28 declaration for Class A/B and Art. 32 appraisal periods for Class C/D
https://vanban.chinhphu.vn/?pageid=27160&docid=204442
2022-01-01
2026-08-29
4
5
months
10
10
working-days
No
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
EU CE Mark
Yes
Serves the same role as a US clearance in the dossier, with no recognition route and no published reduction.
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Regulatory reference
Decree 98 contains a dedicated provision (Art. 36) on handling medical devices with foreign elements involving organizations such as the EU and ASEAN; full provision text not extracted.
Prior approval / evidence record
class-d
Class D
highest
Circulation number registration (Ministry of Health)
45
45
days
official-verified
Nghị định 98/2021/NĐ-CP on the management of medical devices (as amended by Decrees 07/2023, 96/2023, 04/2025) — Art. 28 declaration for Class A/B and Art. 32 appraisal periods for Class C/D
https://vanban.chinhphu.vn/?pageid=27160&docid=204442
2022-01-01
2026-08-29
4
5
months
10
10
working-days
Yes
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
Origin Country Evidence
Evidence Only
Disclosure of marketing approval in a SADC state, WHO Prequalification, US FDA approval, CE marking, or approval in any IMDRF member state
ZAMRA's device application form requires the applicant to disclose its foreign approvals: it must list the SADC states where the medical device has obtained marketing approval, attaching documentation, and state whether the device is WHO prequalified, US FDA approved, CE marked or approved in any IMDRF member state, attaching valid documentation. A separate dossier item requires documentary proof of registration of the product in other countries, specifically those in the SADC region. None of these approvals, however, gives a shortened or substitute route in the guidelines: the non-IVD guideline states only that an application 'shall be evaluated on a first come first serve basis unless expedited evaluation has been authorised by the Authority', and neither the non-IVD nor the IVD guideline provides that a WHO, FDA, CE or IMDRF approval triggers that authorisation or replaces any part of ZAMRA's assessment. An FDA or CE holder therefore still files the full ZAMRA dossier and obtains a Zambian marketing authorisation on ZAMRA's own evaluation. This is disclosure and evidence, not reliance.
Product Marketing
Yes
Yes
Effective from 2024-06-21
Verbatim from Annex I: 'List the SADC states where the medical device has obtained marketing approval (Attach documentation)' and 'Is the device WHO prequalified, US FDA approved, CE Marked or approved in any IMDRF member state? If so attach valid documentation'. Non-IVD guideline section 1(i): 'An application shall be evaluated on a first come first serve basis unless expedited evaluation has been authorised by the Authority.' Definition: '“expedited evaluation” means the express evaluation of a product application within a 90 – day period'.
Prior approval / evidence record
WHO Prequalification; US FDA approval; EU CE marking; approval in any IMDRF member state
No
Disclosure only. The Annex I application form requires the applicant to state whether the device is WHO prequalified, US FDA approved, CE marked or approved in any IMDRF member state and to attach valid documentation, but neither the non-IVD nor the IVD guideline attaches any procedural consequence — no shortened clock, no abridged dossier and no substitute for ZAMRA's own evaluation.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
An FDA, CE, PMDA, MFDS or NMPA approval holder has nowhere to file it in Zimbabwe. Zimbabwe does not operate a general medical device registration pathway: the Medicines and Allied Substances Control Act's registration machinery covers medicines, and devices enter control only through ministerial regulations made under section 38(1)(b). The only device classes ever brought under control are male condoms (SI 183 of 2005) and medical gloves (SI 1 of 2006). For any other device - an infusion pump, an orthopaedic implant, a CT scanner, an IVD - there is no marketing authorisation to apply for, so no foreign approval can open, shorten or substitute for one. MCAZ's own Strategic Plan 2026-2030 records the Medical Devices Unit's entire regulatory function as the assessment of male condoms and medical gloves, and lists an 'expanded scope to medical devices and allied substances' as an effect of a Medical Products and Allied Substances Control Bill that is still only proposed.
none
No Reliance Route
none
Product Marketing
No
Yes
The claim rests on the Act's long title and structure (Part IV, 'REGISTRATION OF MEDICINES', ss.26-41, is the only registration regime in the Act) read together with the exhaustive MCAZ listing of device instruments (only the Condom Regulations, the Glove Regulations and their 2014 amendments) and the Strategic Plan 2026-2030 statement that the Medical Devices Unit's functions are 'Regulation and Quality Conformity Assessment of male condoms in accordance with SI 183 of 2005', 'Regulation and Quality Conformity Assessment of medical gloves in accordance with SI 1 of 2006' and 'Factory inspections (cGMP) of condom and glove manufacturing facilities'. No device registration guideline, application form or device fee schedule exists in MCAZ's published document set.
Regulatory reference
For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and procedure must be established independently; lower-risk devices may self-declare, while other devices require notified-body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
netherlands
All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes
No Reliance Route
none
Product Marketing
null
null
Independent review of current EUR-Lex consolidations supports this bounded ordinary-route conclusion. It does not establish the absence of every special route.
Prior approval / evidence record
geo:nld
EU CE under MDR/IVDR
Single Market Validity
direct
Product Marketing
Yes
No
No
EU baseline confirmed; national conditions (Dutch IFU language, notification duty, IGJ vigilance channel) apply on top.
Prior approval / evidence record
FDA 510(k)/PMA
No
No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
What review, validation, and applicant stop-clock rules apply?
For clinical investigation applications, the member state must notify the sponsor of the authorisation decision within 45 days of the validation date (Art. 70(5)), extendable by a further 20 days for the purpose of consulting with experts; once notified, and absent a negative ethics opinion valid for the entire member state, the sponsor may start the investigation with the devices referred to in the application.
Effective from 2021-05-26
The fixed statutory clock in the MDR is the clinical-investigation authorisation clock; no statutory review deadline is fixed for notified-body conformity assessment itself.
Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?
An exemption from the requirements of MDR art. 59(1) / IVDR art. 54(1) can be granted by the Minister of VWS on the basis of art. 8(4) Wet medische hulpmiddelen in combination with art. 4(2) Regeling medische hulpmiddelen; the IGJ advises on the application. Applications are made with a Dutch or English form sent by email to CIBGOntheffingenMedischeHulpmiddelen@minvws.nl; positive decisions are published in the Staatscourant.
Substantive ontheffing conditions also in Wmh art. 9c (restrictions, withdrawal, publication in Staatscourant).
The Netherlands permits reprocessed single-use medical devices to be offered on the market only if they comply with the requirements set by or under the Wet medische hulpmiddelen; the Besluit medische hulpmiddelen (arts. 4-7) sets the national conditions for reprocessing and further use of single-use devices, implementing MDR art. 17.
Besluit medische hulpmiddelen (BWBR0043470), decree of 24 April 2020.
How are deficiencies answered, clocks handled, and decisions escalated or appealed?
Decisions on clinical investigations with medical devices can be challenged through national routes: administrative appeal to the CCMO against a decision of an accredited MREC (medical research ethics committee), objection against a CCMO decision, and objection against negative validation of the investigation file.
Routes listed on the CCMO website: 'Administrative appeal against MREC decree', 'Objection to a CCMO decision', 'Objection to negative validation'.
Which UDI, device listing, database, and traceability duties apply?
EUDAMED UDI/Device registration module is the official device listing surface, mandatory from 28 May 2026 (Besluit (EU) 2025/2371); devices already on the EU market before that date must be registered by 28 November 2026; the national NOTIS system continues only for custom-made device registration and mutations of existing notifications
Effective from 2026-05-28
Dates stated on the Farmatec notifications page referencing Besluit (EU) 2025/2371.
What is reportable, by whom, where, in what format, and by what deadline?
Until EUDAMED vigilance reporting becomes mandatory, manufacturers and authorised representatives report serious incidents to the IGJ using the MIR form (Manufacturer Incident Report), sent by email to meldpunt@igj.nl with the completed form attached as PDF; once EUDAMED is fully functional it becomes the central reporting point.
IGJ: 'Volgens die regels bent u verplicht deze meldingen te doen in EUDAMED' — until then reports go to IGJ.
netherlands:medical-device
netherlands
EU MDR classes I, Is, Im, Ir, IIa, IIb and III
National projection of the directly applicable EU MDR classification. The canonical class axis and rules are maintained in eu:medical-device; national references describe only administration or local deltas.
i
Class I
low
is
Class Is
low
im
Class Im
low
ir
Class Ir
low
iia
Class IIa
medium
iib
Class IIb
high
iii
Class III
highest
Farmatec
official-source-verified
eu:medical-device
Regulation (EU) 2017/745, Art. 51 and Annex VIII
https://eur-lex.europa.eu/eli/reg/2017/745/oj
2026-08-26
Netherlands
netherlands
NL
🇳🇱
Health and Youth Care Inspectorate (IGJ), with CIBG/Farmatec registration desks
IGJ
europe
3
4-class (I, IIa, IIb, III) — EU MDR
class-i
Class I
low
Self-declaration (no notified body)
0
0
days
official-verified
EUR-Lex Regulation (EU) 2017/745 (MDR)
https://eur-lex.europa.eu/eli/reg/2017/745/oj
2026-08-25
6
9
months
No
No
Yes
FDA 510(k)/PMA
No
No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file
Yes
EU Authorized Representative
No
ISO 13485 accepted as QMS evidence
5 years (CE certificate)
2026-08-29
partially-verified
Commission Implementing Regulation (EU) 2026/977, Art. 2 — maximum notified-body conformity assessment timelines (30 + 120/90 parallel + 20 days)
https://eur-lex.europa.eu/eli/reg_impl/2026/977/oj
2027-02-25
2026-08-29
EUR-Lex Regulation (EU) 2017/745 (MDR)
https://eur-lex.europa.eu/eli/reg/2017/745/oj
2026-08-25
EUR-Lex MDR consolidated text — Annex IX §5.1 (expert-panel clinical evaluation consultation: 21/60 days) and §5.2(d) (ancillary medicinal-substance opinion: 210 days)
https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02017R0745-20250110
2026-08-29
2026-08-29
default
planning-template
Maintained planning steps and estimates, not verified regulator deadlines.
1
Pre-Submission Preparation
Gather technical documentation, quality management system (QMS) records, and clinical data required by IGJ. Appoint a EU Authorized Representative.
1-3 months
📋
2
Application Submission
Submit complete registration dossier to IGJ including device description, risk analysis, and testing reports.
1-2 weeks
📤
3
Administrative Review
IGJ reviews application for completeness. May request additional documents or clarifications.
2-4 weeks
🔍
4
Technical Evaluation
In-depth technical assessment of device safety and performance. IGJ may issue questions.
0 days
⚙️
5
Registration Approval
Upon successful review, IGJ issues Netherlands market authorization certificate.
1-2 weeks
✅
netherlands
Netherlands
NL
Farmatec (CIBG)
62
62
EUR
No
200
200
EUR
No
national-notification-fee
National device-notification fee
EUR
200
EUR 200
Per notification
Due under the Dutch notification duty (kept alive by Wmh art. 24–25); remains due until EUDAMED becomes operational, after which EUDAMED registration is free.
exact-current
official-verified
https://zoek.officielebekendmakingen.nl/stcrt-2020-24039.html
Netherlands Staatscourant 2020/24039: device notification fee EUR 200
2026-08-25
export-certificate
Free-sale / export certificate
EUR
62
EUR 62
Per certificate
Plus a one-off EUR 62 administrative fee per invoice per quarter; fixed in art. 3 Regeling medische hulpmiddelen.
exact-current
official-verified
https://www.farmatec.nl/medische-hulpmiddelen/exportverklaring-medische-hulpmiddelen
Farmatec: export certificate for medical devices (EUR 62)
2026-08-25
2026-08-25
official-verified
Netherlands Staatscourant 2020/24039: device notification fee EUR 200
https://zoek.officielebekendmakingen.nl/stcrt-2020-24039.html
2026-08-25
Farmatec: export certificate for medical devices (EUR 62)
https://www.farmatec.nl/medische-hulpmiddelen/exportverklaring-medische-hulpmiddelen
2026-08-25
2026-08-25
exact-current
Yes
netherlands
Netherlands
high
lvd-medical-exclusion-mdr-electrical-safety
MDR electrical safety in place of the Low Voltage Directive
Medical Electrical Safety
Included In Medical Registration
Finished Device
Annex II of Directive 2014/35/EU places electrical equipment for radiology and medical purposes outside the Low Voltage Directive, so there is no separate national electrical-safety certificate for a medical device. Electrical safety is assessed inside the MDR conformity assessment against MDR Annex I, with the harmonised IEC/EN 60601 series carrying the presumption of conformity.
candidate
emc-directive-disapplied-by-mdr
MDR electromagnetic compatibility in place of the EMC Directive
emc
Included In Medical Registration
Finished Device
Article 2(3) of Directive 2014/30/EU switches the EMC Directive off where other Union legislation lays the same essential requirements down more specifically, which MDR Annex I sections 18.5 and 18.6 do for medical devices. EMC is therefore dossier evidence inside the CE route and not a separate national EMC conformity step.
candidate
besluit-radioapparaten-2016-conformity
Besluit radioapparaten 2016 conformity
Radio Spectrum
Mandatory If Feature
Radio Equipment
Article 3(1) of the Besluit radioapparaten 2016 (Stb. 2016, 525), made under the Telecommunicatiewet to implement Directive 2014/53/EU, requires radio equipment to meet the essential requirements of Article 3(1) and (2) of the Directive, and Article 3(3) requires conformity to be demonstrated through one of the Article 17 conformity-assessment procedures. Conformity therefore runs exclusively through the RED modules with no national approval in the decree; the Rijksinspectie Digitale Infrastructuur supervises equipment.
candidate
regeling-gevaarlijke-stoffen-eea-rohs
Regeling gevaarlijke stoffen in elektrische en elektronische apparatuur (RoHS)
Environmental And Batteries
Evidence Only No Separate Certificate
Electrical Electronic Medical Device
Article 3(1) of the Regeling of 11 December 2012, made under articles 9.2.2.1 and 21.6(6) of the Wet milieubeheer, prohibits placing electrical and electronic equipment — including cables and spare parts for repair, reuse, functional updating or capacity upgrading — on the market where a homogeneous material exceeds the Annex II maximum concentration values of Directive 2011/65/EU. Directive 2011/65/EU Annex I category 8 covers medical devices, Article 4(3) has bound medical devices since 22 July 2014 and in vitro diagnostic medical devices since 22 July 2016, and Article 2(4)(h) excludes active implantable medical devices.
candidate
nationaal-weee-register-producer-registration
Nationaal (W)EEE Register producer registration
Environmental And Batteries
Mandatory If Feature
Producer Or Authorised Representative
Article 18 of the Regeling afgedankte elektrische en elektronische apparatuur puts the Stichting Nationaal (W)EEE Register in Zoetermeer in charge of setting up and running the register required by Article 16(1) of Directive 2012/19/EU, and Article 19(1) requires a producer to report itself to that register. That is a bare duty to register rather than a condition precedent to placing equipment on the market. In practice producers register through Stichting OPEN, because the waste-management contribution agreement has been declared universally binding. Directive 2012/19/EU Article 2(4)(g) excludes devices expected to be infective before end of life and active implantable devices; other medical devices are in scope, and Article 16 requires each Member State to keep a producer register.
candidate
batteries-regulation-register-not-yet-live
Batteries Regulation producer register announced but not yet operating
Environmental And Batteries
Transition Not Yet Mandatory
Battery Producer Or Authorised Representative
This is a live transition rather than a settled duty. Rijkswaterstaat states that the extended-producer-responsibility duties of the Batteries Regulation have applied since 18 August 2025, that all producers must be entered in the national producer register to place batteries on the Dutch market and must apply digitally to Rijkswaterstaat, but also that the national legislation still has to be amended, that the process is delayed, that no decisions can yet be taken on registration and approval applications, and that the register is still being built. The Uitvoeringsbesluit hoofdstuk VIII EU-verordening batterijen received Council of State advice on 6 November 2025 and has not been promulgated; the Regeling beheer batterijen en accu's 2008 still on the books implements the repealed Directive 2006/66/EC. Article 11(2)(b) of Regulation (EU) 2023/1542 lets professional medical imaging and radiotherapy devices and in vitro diagnostic medical devices restrict portable-battery replacement to independent professionals, and Article 11(3) lifts the removability duty where continuity of supply is needed for safety or data integrity.
candidate
anvs-vergunning-toestellen-en-versnellers
ANVS vergunning for devices and accelerators
Ionizing Radiation
Mandatory If Feature
Radiation Device Practice Or Service Activity
Besluit basisveiligheidsnormen stralingsbescherming art. 3.5 forbids any handeling with a toestel or versneller in an art. 3.8 category without a licence granted by the Autoriteit (ANVS). Art. 3.8(2) covers devices used for therapeutic and for diagnostic exposure of persons and animals, non-medical imaging, research and development work on such devices and, in art. 3.8(2)(i), installing, dismantling, repairing, maintaining and quality-controlling a toestel or versneller — which places supplier service organisations inside the licence, not only the clinical operator. Art. 3.8(3) adds administration of radioactive substances for medical or veterinary diagnosis and therapy.
unresolved
anvs-registratie-handel-en-opslag
ANVS registratie for trade storage and lower-risk devices
Ionizing Radiation
Mandatory If Feature
Device Storage For Trade Or Distribution
Where the licence duty does not apply, art. 3.9 and art. 3.10(2) impose ANVS registration. Art. 3.10(2)(b) registers holding a toestel or versneller purely in storage for trade, distribution and installing or removing it without operating it under high voltage, which is the ordinary position of a distributor. Art. 3.10(2)(d) and (e) register veterinary diagnostic devices with a fixed downward beam and fixed-location dental diagnostic devices other than cone-beam CT, and (f) devices used in population screening.
unresolved
EUR-Lex
Low Voltage Directive 2014/35/EU Annex II — electrical equipment for radiology and medical purposes outside scope
https://eur-lex.europa.eu/eli/dir/2014/35/oj
EUR-Lex
EMC Directive 2014/30/EU Article 2(3) — more specific Union legislation displaces the directive
https://eur-lex.europa.eu/eli/dir/2014/30/oj
EUR-Lex
RoHS Directive 2011/65/EU Annex I category 8 and Article 4(3) medical-device application dates
https://eur-lex.europa.eu/eli/dir/2011/65/oj
EUR-Lex
WEEE Directive 2012/19/EU Article 2(4)(g) medical-device exclusions and Article 16 national producer register
https://eur-lex.europa.eu/eli/dir/2012/19/oj
EUR-Lex
Batteries Regulation (EU) 2023/1542 Articles 11 and 55 — medical-device removability derogation and producer register
https://eur-lex.europa.eu/eli/reg/2023/1542/oj
Overheid.nl (Wettenbank)
Besluit radioapparaten 2016 artikel 3 — essential requirements and Article 17 conformity assessment
https://wetten.overheid.nl/BWBR0038910/2024-01-27
Overheid.nl (Wettenbank)
Regeling gevaarlijke stoffen in elektrische en elektronische apparatuur artikel 3 — RoHS placing-on-market prohibition
https://wetten.overheid.nl/BWBR0032405/2024-01-01
Overheid.nl (Wettenbank)
Regeling afgedankte elektrische en elektronische apparatuur artikelen 18 and 19 — Nationaal (W)EEE Register and producer registration
https://wetten.overheid.nl/BWBR0034782/2024-01-01
Rijkswaterstaat (Afvalcirculair)
extended producer responsibility for batteries — register under construction and applications on hold
https://afvalcirculair.nl/uitgebreide-producentenverantwoordelijkheid-upv/overzicht-upv/upv-batterijen/
Overheid.nl (Wettenbank)
Besluit basisveiligheidsnormen stralingsbescherming — licence, registration and notification duties
https://wetten.overheid.nl/BWBR0040179/2024-01-01
