Registration pathways by country

Custom made devices and clinical investigation devices must be registered before being put into use and are exempt from CE marking, filing instead the special declaration per Annex VIII of VKM 731/2015; a single group registration is allowed for devices of the same manufacturer placed on the market by the same wholesaler when covered by the same conformity certificate.

All devices placed on the market must be registered in the National Register of Medical Devices (Regjistri Kombëtar i Pajisjeve Mjekësore) kept by AKBPM. For classes II and III the application is filed by the manufacturer, the manufacturer's representative in Albania, or a wholesale trader holding the manufacturer's authorization, and AKBPM issues a registration certificate. For class I, any subject placing the devices on the market applies electronically and AKBPM notifies the subject electronically of registration within 5 working days.

The registration application is filed with AKBPM before the first customs clearance of the device; after registration the subject has no obligation to obtain the registration certificate again for the same device for each import. Domestic manufacturers apply within 15 days of CE certificate issuance (Order 360 point 5).

Under the original Order 360/2016 point 4, the application was filed with AKBPM within 15 working days starting from the date of customs clearance of the devices.

Only agréé pharmaceutical manufacturing and/or exploitation (distribution) establishments, as defined in Articles 218 and 219 of loi n° 18 11, may file a device homologation application with ANPP; the homologation decision can likewise only be granted to such establishments.

Locally manufactured devices destined exclusively for export must also be homologated, after opinion of the homologation commission, under a dedicated arrêté procedure (arrêté of 23 June 2021): application must state the exclusive export destination, follows the standard dossier, with a 90 day decision (extendable 30 days) and a decision valid 5 years.

Route to market is the national homologation procedure before ANPP: dossier deposited by an agréé pharmaceutical establishment (appointment via rdvdm.anpp.dz; reception days Sunday, Monday, Wednesday), admissibility check, technical evaluation, commission opinion, decision of the ANPP Director General. Since 15 March 2026, homologation dossiers are deposited in digital format per ANPP Note N°28 2026, and Note N°39 2026 governs lifting of reservations on DM dossiers.

Registration route splits by class: Class I and II registrations, modifications and reválidas are processed under Disposición ANMAT 5706/2017 (Art. 1); Class III and IV registrations under Disposición ANMAT 727/2013 (Art. 2), with their data modifications also under 5706/2017; IVDs under Disposición ANMAT 2198/2022. All routes end in the Registro de Productos Médicos.

IVDs (reactivos de diagnóstico in vitro) in Groups A and B are registered by Declaración de Conformidad (declaration of conformity), with 15 administrative working days for ANMAT to evaluate the documentation.

Devices registered in Armenia may be imported. Devices that have no Armenian state registration may also be imported in the cases the Law allows — the categories exempt from mandatory registration, devices imported in the name of an individual patient for that patient's course of treatment (including on vital indications), for health maintenance or for personal use, devices intended for exhibitions, conferences or similar events without the right of subsequent sale (subject to destruction or re export), and devices intended for examination for the purposes of state registration or of making changes to the registration documents. Import is permitted on the basis of an import (conformity) certificate; the Government fixes the list of documents required for the examination carried out for the purposes of import. The import certificate is not required for personal use imports by natural persons, imports by international organisations and foreign diplomatic and consular representatives and their staff and families for their own needs, devices needed for the medical care of drivers, crew members and passengers arriving in Armenia, and the further cases listed in Article 47.2(5).

Circulation in Armenia is permitted for medical devices that are registered in Armenia, except for four categories that are not subject to mandatory registration: (1) the medical devices defined by Article 4(11) of the EAEU Agreement of 23 December 2014; (2) devices imported under programmes qualified as charitable or humanitarian in the procedure established by legislation, after agreement with the authorised body under the Government established humanitarian aid procedure for forming, agreeing, receiving, recording and distributing orders of medical devices; (3) devices for which demand arises in emergencies or under martial law; (4) devices imported for state needs in the cases established by the authorised body, where the corresponding legal act of the authorised body exists. Registration, refusal of registration, suspension, invalidation of the registration certificate, issue of duplicates and changes to the registration certificate are carried out by the authorised body (Ministry of Health) in the procedure established by legislation, and identical requirements apply both to devices manufactured in Armenia and to devices imported from other states.

Manufacturer's Evidence must be submitted to and accepted by TGA before the sponsor commences the device inclusion application; documents attached to the application are assessed in addition to that evidence.

Unless exempt, a device must be included in the Australian Register of Therapeutic Goods (ARTG) before supply: the Australian sponsor lodges an inclusion application via TGA Business Services after acceptable Manufacturer's Evidence is in place, and TGA performs a 20 working day preliminary assessment plus any mandatory or discretionary audit before inclusion.

The Austrian register for medical devices (medizinprodukteregister.at) is a free, web based database operated by Gesundheit Österreich GmbH (GÖG, ÖBIG division) on behalf of the Ministry; it records custom made device manufacturers, distributors, and testing, inspection and certification bodies; entries are made self service by each company, which sees only its own data.

submissionSurface: EUDAMED (actor registration verified/validated by BASG; actor, device and certificate modules mandatory since 28 May 2026) plus the Austrian Medizinprodukteregister (GÖG) for custom made device manufacturers, distributors and testing/inspection/certification bodies · verifiedHighlights: BASG verifies Austrian EUDAMED actor registration requests; manufacturers, authorised representatives and importers receive an SRN on registration.; Devices already on the market before 28 May 2026 must be registered in EUDAMED by 28 November 2026 at the latest.; All certificates must be registered in EUDAMED by the notified bodies by 28 May 2027.

Beyond EUDAMED, Austria requires national registration before taking up activity: manufacturers of custom made devices (Art. 2(3) MDR) and distributors (Art. 2(34) MDR / Art. 2(27) IVDR) must register with a body designated by the Federal Ministry; testing, inspection and certification bodies must notify their activity; changes to the notified data must be reported immediately (unverzüglich).

There is one registration pathway for medical devices: application to the Ministry of Health, expertise by the Analytical Expertise Center, and issue of a registration certificate by the Ministry. It applies only to devices classified as higher than high, high and/or medium risk; devices below that threshold are outside the state registration requirement.

Bahrain operates an ordinary route through the Ajheza/Madar electronic system and a paid fast track delivered through third party companies, with a shorter review clock (10 working days against 20). The device is registered by the same NHRA process in both cases.

Only a registered authorized representative can apply for medical device registration in Bahrain. All devices that have been imported or are intended to be imported must first be listed with the medical devices section by submitting the listing sheet to medical devices@nhra.bh; only listed devices can then be submitted for registration. Listing must be sent before the registration application and is not part of it.

All medical devices of Class B, C and D must be registered with DGDA before they are imported or manufactured into Bangladesh; application must be made before first import/manufacture (and immediately for products already on the market when the guideline issued).

No person or entity may manufacture, import, export, sell, distribute, stock or display any drug (including medical devices) without registration from the Licensing Authority (DGDA); before distributing, marketing or selling a registered product a Marketing Authorization Certificate (মার্কেটিং অথরাইজেশন সনদ) must be obtained; registration is not granted without the recommendation of the Drug Control Committee.

Belarus operates two parallel market admission routes: national state registration by the Ministry of Health (CM Resolution 211/2026, admin procedure 9.3.1) and registration within the EAEU framework under the Agreement of 23.12.2014 (admin procedure 9.3.6). Devices may be placed on the market after either registration.

National registration, reregistration and dossier changes are preceded by a package of preliminary technical works run by RUP CEIZ: primary document expertise, production inspection, biological effect testing (all devices), technical testing (domestic devices only), specialized document expertise, Ministry assigned clinical trials, and clinical evaluation based on clinical data with proof of equivalence (for large fixed equipment and class 1 devices).

State registration is required for: devices first created in Belarus; foreign made devices first offered in Belarus; devices analogous to registered ones but made by another producer; previously registered devices when a new production site is added; components of other devices that are sold/used separately; and limited quantity supplies for defined public interest purposes.

Distributors of medical devices must register on the FAMHP web portal under Article 4 of the Royal Decree of 15 November 2017 on the notification of a materiovigilance contact point within hospitals and the registration of distributors of medical devices. Distributors must NOT register in EUDAMED.

Registration of in house devices via the FAMHP web portal (declaration of manufacture) is mandatory since 26 May 2021 for in house medical devices and since 26 May 2024 for in house in vitro diagnostic medical devices.

Beyond actor registration, the FAMHP web portal hosts national notifications: distribution of implants, of long term invasive devices and of mobile applications; manufacture of custom made devices; devices manufactured and used only within health institutions; reprocessing of single use devices and use of reprocessed devices within health institutions; applications for electronic certificates of free sale; and the annual turnover declaration.

statement: For medical devices considered biomedical equipment, AGEMED issues 'Certificados de Comercialización' that recognise a declaration made by the manufacturer or the Bolivian representative, covering that the equipment is not under experimentation, that spares and maintenance can be supplied for five years or the equipment's useful life, that operator training will be provided, and that operation, installation and maintenance manuals in Spanish will be supplied. AGEMED resumed issuing these certificates and set a maximum issuance time of 5 working days from filing on the MISA platform, on payment of the service fee. · article: Numeral 1

statement: AGEMED maintains a list of medical devices that are not subject to Registro Sanitario (annex to Circular MS/AGEMED/CR/43/2018, 133 items with codes, e.g. ampoule openers, bath pillows, safety eyewear, balances, hospital beds, stretchers, carts, cushions, bedpans, laboratory aprons, dispensers, exercisers, X ray shields, sheets, chairs, stools, slippers), subject to permanent and periodic review; companies must still report the commercialisation of those products to AGEMED. Numeral 7 of the same circular, which confined the 'certificados de comercialización' service to devices on that list, was left without effect by Circular MSyD/AGEMED/CR/86/2023 numeral 9 (13 December 2023), which applies item 140 of Resolución Ministerial N° 0265/2018 ('otras certificaciones no especificadas') to such certifications instead. · article: Numerales 5 and 7

statement: The modalities that require a Registro Sanitario are: manufacture and market, import and market, import, import and pack and market, import, semi process and market, import, assemble and market, manufacture and export, and import, condition and market. Devices are registered by group — one Registro Sanitario for each group — using the grouping table in Anexo 2 of the manual. · article: Numeral 1.5 and Capítulo II chapeau

statement: Every product to be manufactured, imported, exported, acquired, distributed, marketed, prescribed and dispensed in Bolivia must previously hold a Registro Sanitario granted indelegably; Article 10 defines the Registro Sanitario as the procedure by which a pharmaceutical product passes through a strict pre marketing evaluation. · article: Art. 11

An application for entry in the Register of medical devices may be submitted only by a manufacturer of medical devices with its seat in Bosnia and Herzegovina, or by a legal person representing a foreign manufacturer which has its seat in Bosnia and Herzegovina. A foreign manufacturer cannot apply directly.

The Agency decides on the entry of a medical device in the Register of medical devices by a certificate of entry, which it is obliged to issue within 90 days of receipt of a complete application. No appeal is permitted against this certificate, but an administrative dispute may be brought.

A formally complete registration application consists of the completed application form for the register of medical devices of the corresponding class (form REG MS KL for general medical devices, form REG IV MS for in vitro diagnostic medical devices), signed and certified by the applicant, together with the completed Annex 1 (Dodatak 1) listing the devices. Incomplete applications are returned to the applicant for amendment within a set period; if the applicant does not complete the application within that period the Agency rejects it by a conclusion.

It is prohibited to market medical devices that are not entered in the register of medical devices kept by the Agency, in addition to the prohibition on marketing devices that do not conform to the prescribed general and special requirements (Zakon 58/08, Član 108. stav (2), restated in Pravilnik 71/12, Član 6. stav (2)). Entry in the Register is an administrative procedure conducted by the Agency for the purpose of recording the medical devices on the market in BiH and protecting public health, and it is by that entry that the applicant acquires the right to place the device on the market of Bosnia and Herzegovina (Pravilnik 4/10, Član 65. stav (4) and (8)).

For general medical devices in Class B, C and D there are two registration pathways: full evaluation and abridged assessment. Full evaluation applies where the device has no prior approval from any SRA or RRA, is novel, is not identical to a device already registered in Botswana, or does not meet the abridged criteria. Abridged assessment applies where the device already holds approval from a reference or stringent authority (see the reliance facts). Class A and other notifiable devices go through a separate notification pathway.

The IVD registration guideline mirrors the general device structure: applicants for IVD medical devices are guided on abridged and full registration assessment pathways, and the guideline applies to all Class B, C and D IVD medical devices. Class A IVDs go through the notification guideline instead.

BoMRA's device strategy sets out a phased move from listing to mandatory registration: Class C and D registration opened in April 2024 with a mandatory deadline of 30 June 2026; Class B opened on 1 April 2026 with a deadline of 31 March 2027; Class A (notification) opens on 1 October 2026 with a deadline of 30 September 2027. Once a deadline passes, the device is removed from the Listing Register and must be on the Registration Register.

Two market routes: class I and II devices are subject to notification (notificação) and class III and IV to registration (registro). Notifications have no technical analysis and are processed within 30 days.

ANVISA grants notification or registration for families, systems and sets (kits) of medical devices; grouping follows the rules of the regulation.

AITI's Advisory Guidelines require both a Type Approval and an Import Permit to import telecommunications or radio communications equipment for personal or commercial use, and Type Approval must be obtained first. Dealer Type Approval is required for commercial import and only a holder of a valid Dealer Licence may apply; Level 1 Type Approval is also called Equipment Registration.

Section 10(1) of the Medicines Act prohibits the manufacture, sale, supply or import of an unregistered 'medicinal product', and s. 11(1) empowers the Authority to register only 'any medicinal product'. Because s. 4(1) excludes instruments, apparatus and appliances from that term, no pre market registration, notification or product licence exists or can be applied for in respect of a medical device or IVD.

Section 7(1) of the Radiation Protection Act prohibits importing, exporting, keeping, possessing, using, manufacturing, selling or dealing in any 'controlled apparatus' except under and in accordance with a licence granted by the Authority under s. 8. Contravention carries a fine of up to $100,000 and up to 5 years' imprisonment for an individual, or a fine of up to $10,000,000 for a body corporate.

Manufacturers of Class I devices, custom made device manufacturers and persons under ЗМИ Art. 21 22 (systems/procedure packs, pre use sterilisation) must file an application for registration on the official form to the Executive Director of ИАЛ (BDA) no later than 14 days after placing the device on the market and/or into service in Bulgaria.

For class IIa, IIb and III devices (including active implantable devices) put into service in Bulgaria, ИАЛ (BDA) may request device identifying data, the label and the instructions for use; there is no national registration duty for these classes.

Applications for registration of IVDs under ЗМИ Art. 28(1) and (3) (List A, List B, self testing and other in vitro diagnostic devices) must be filed with BDA within 14 days of placing on the market and/or into service in Bulgaria.

submissionSurface: BDA national register under ЗМИ Chapter Two (чл. 27 devices; чл. 28 IVDs), plus EUDAMED as the EU shared layer (BDA feeds it under чл. 118 ЗМИ) · verifiedHighlights: Class I manufacturers (incl. sterile/measuring), custom made device makers and systems/procedure pack assemblers, and IVD List A/B and self test manufacturers, must apply for BDA registration within 14 days of placing on the market/into service in Bulgaria (ЗМИ Art. 27(1), Art. 28(6)).; For class IIa, IIb and III devices (incl. active implantable) there is no national registration duty; BDA may request device identifying data, label and IFU (ЗМИ Art. 30).; Where the manufacturer is not established in the EU/EEA, the authorised representative files the registration (ЗМИ Art. 29).

A medical device intended for the Cambodian market must be registered with Cambodia's own regulatory authority; the ASEAN Medical Device Directive under which Cambodia's controls are aligned provides that a device to be placed on the market of a Member State shall be registered with the Regulatory Authority of that Member State, that each Member State shall put in place an appropriate system for that registration, and that the authority may exempt certain devices from the registration requirement where appropriate.

Class I market access runs through the Medical Device Establishment Licence: Class I manufacturers, and importers or distributors of all four classes, hold an MDEL to permit importation or sale instead of a product licence.

Class II, III and IV devices require a Medical Device Licence (MDL) held by the manufacturer before any person may import or sell them; Class I devices are outside the product licence route and are controlled through establishment licensing.

model: Mandatory sanitary registration (registro sanitario) with ISP currently applies to 10 DM/DMDIV types per the ISP ANDIM page (as of 2026 08): surgical latex gloves and medical examination latex gloves and latex condoms (Decreto Exento 342/2004); sterile single use hypodermic needles and syringes (Decreto Exento 1887/2007); synthetic and female condoms (Decreto Exento 93/2018); portable automated external defibrillators (Decreto Exento 42/2021); HIV self test IVDs (Decreto Exento 41/2022 and 96/2022); professional use HIV detection IVDs (Decreto Exento 41/2022 and 15/2024). · upcoming: Immunohematological reagents (Decreto Exento 5/2025, in force from 21 February 2026); 39 further categories (Decreto Exento 25/2026); blood donation microbiological screening reagents (Decreto Exento 31/2026).

From the transition schedule dates of Decreto Exento N°25/2026, the listed devices/IVDs may only be manufactured in Chile, imported, marketed or distributed if they hold the corresponding verification of conformity, which for these purposes is a registro sanitario granted by ISP.

Domestic Class II registration is reviewed and approved by provincial drug regulatory departments; domestic Class III and all imported devices (Class I filing and Class II/III registration) are handled by NMPA, with CMDE (NMPA center for medical device evaluation) conducting technical review of NMPA level applications.

Class I devices are subject to product filing (备案); Class II and Class III devices are subject to product registration (注册) with acceptance, technical review and administrative decision.

I; IIa

Classes I and IIa obtain an automatic registro sanitario issued within 2 days of complete documentation; classes IIb and III obtain a registro sanitario after technical/legal evaluation with a 90 business day statutory term from completeness; controlled technology biomedical equipment requires permiso de comercialización.

Equipos biomédicos de tecnología controlada require a permiso de comercialización from INVIMA (instead of registro sanitario); equipment using radiation additionally needs an authorization from the competent radiation authority.

Medical devices and biomedical equipment that are not controlled technology of risk classes IIb and III require a registro sanitario issued by INVIMA before production, import, export, processing, packaging, storage, sale or marketing.

Class 1 EMB do not require sanitary registration for marketing and use, but import, labeling, advertising, vigilance and control requirements still apply to them. The Ministry trámite page cites Decreto N° 41387 S for the class 1 exemption; class 1 products may state on the label that they are exempt.

One application may cover multiple presentations of a product, dilutions of the same pure product, a test kit, an EMB family, a group of EMB, a family of groups, or a system, provided the specific use does not vary; a single registration number is assigned and a single trámite implies a single payment. Adding members or changing composition requires a post registration change; products with different composition require separate registrations.

All EMB may only be manufactured, imported, marketed or distributed in Costa Rica if they hold the respective sanitary registration; applications for registration, renewal and post registration changes are filed through the Regístrelo platform (www.registrelo.go.cr). Classes 2 4 register; class 1 is exempt from registration.

No pharmaceutical product for human use may be placed on the Ivorian market, whether free of charge or for payment, without first obtaining an authorisation from the AIRP. Devices to be homologated go through a national conformity assessment against the essential requirements of safety, quality and performance, sanctioned by an Autorisation de Commercialisation. There is no class based self certification or notification only route in the published procedure.

The introduction into Côte d'Ivoire of any medical device, whatever its class, is subject to a prior declaration by each actor in the supply chain to the AIRP. This declaration, called the listing of medical devices, is made on a declaration form available from the AIRP website. It is a separate obligation from, and additional to, the homologation of the device itself.

There is no Croatian device registration or approval procedure that a manufacturer applies for: prior to placing a device on the market the manufacturer must undertake a conformity assessment in accordance with the applicable procedures in MDR Annexes IX to XI (IVDR Annexes IX to XI correspondingly), using a notified body unless the device is Class I and self certified. The Croatian layer is the registration of the economic operator and of the device, not the approval of the product.

HALMED operates a national notification of placing a medical device on the market (obavijest o stavljanju medicinskog proizvoda u promet), separate from EUDAMED registration. HALMED states that for devices entered in the European database EUDAMED no notification of placing on the market needs to be sent, provided the Republic of Croatia is named as a market in which the device is distributed. Devices that are not in EUDAMED must be notified to HALMED.

Per Article 41 of the Reglamento, a sanitary registration application may only be filed by manufacturers inscribed with the national regulatory authority, either directly (if they hold a CECMED client contract) or through a duly authorized suministrador representing them, which must also be inscribed and hold a CECMED client contract.

Proceder E (Complete Evaluation with Regulatory Audit) applies to sensitive devices (Anexo 4 list: infusion/transfusion sets, condoms, thermometers, sutures, intraocular lenses, X ray tubes, orthopedic implants, gloves) of Class IIb/III from China, India, Pakistan, Russia, Latin America and new markets that are new manufacturers or new devices of an already inscribed manufacturer; to devices from any market of a manufacturer with prior quality difficulties; and to other devices subject to import control. The audit covers the QMS and gathers registration evidence.

Registration applications are processed through one of five differentiated evaluation procedures: A Simplified (all Class I unless sterile, measuring instruments, sensitive, electromedanical/mechanical or novel); B Basic (Class I sterile/measuring and Class I IIa of listed categories with valid origin country registration); C Complete (Class IIb, III, novel devices, devices without origin country registration, national production); D Simplified Update (significant updates of already registered Class IIb/III devices of the same manufacturer); E Complete with regulatory audit (adds QMS audit).

Under Decree No. 7, made under article 59(1)(ζ) of the Cypriot Basic Requirements laws and published in the Third Annex, Part II of the Official Gazette of the Republic of Cyprus No. 4462 of 5 January 2012, every manufacturer of medical devices having its seat in the Republic, and every importer or distributor of medical devices, must within six months of the issue of the decree notify the competent authority, in electronic form at cymda@mphs.moh.gov.cy, of the address of its seat and of a list of all the medical devices bearing its name or which it places on the Cypriot market. CYMDA's current practice is a completed Excel notification file sent to the same address.

Cyprus issues no national pre market approval for a medical device. The only procedure CYMDA describes for a manufacturer to affix the CE marking is the Union conformity assessment procedure: the manufacturer must document that the device bearing its name meets the essential requirements of Annex I of the relevant legislation, following the conformity assessment procedure that the legislation lays down for the type of device, and where that procedure requires a notified body the manufacturer may approach a body of its choice within the body's notified scope. The manufacturer then affixes the CE marking, accompanied by the notified body's four digit number where a notified body was involved, and draws up a declaration of conformity.

CYMDA states that the notification of a medical device by one economic operator is independent of the notification of the same device by another economic operator. Each importer and each distributor that places or makes a device available on the Cypriot market must therefore notify it to CYMDA in its own right under Decree No. 7, in addition to the manufacturer's or authorised representative's own notification.

A custom made device manufacturer seated in the Czech Republic must provide to SÚKL via ISZP: information on start of activity within 30 days of starting production, a list of generic device groups supplied to the Czech market within 6 months of starting production, and information on termination of activity. SÚKL assigns a registration number via ISZP (§ 8(6)); on request the manufacturer supplies a list of devices for the last 10 years, or 15 years for implants (§ 8(5)).

Until the EUDAMED device module is fully functional, medical devices and IVDs are notified through the Register of Medical Devices (RZPRO) established by the former Act No. 268/2014 Sb. (as in force before Act 375/2022 Sb. took effect).

The § 23(1) notification duty does not apply to: (a) a service person servicing exclusively class I devices or class A IVDs; (b) a distributor supplying exclusively class I devices or class A IVDs, or supplying exclusively to users who are not healthcare providers; (c) healthcare providers that are pharmacies for the device list content (§ 23(3)).

Distributors and service persons must notify their activity to SÚKL via ISZP before starting the activity; SÚKL assigns each notified person a registration number (§ 24(1)).

Applications for a free sale certificate (FSC) are submitted to SÚKL via ISZP; the application must state the basic UDI DI where assigned, and whether an electronic or paper certificate is requested. SÚKL verifies in EUDAMED that the device is registered with no impeding change (§ 10(3)) and issues the FSC via ISZP in Czech and English (§ 10(4)).

submissionSurface: EUDAMED for MDR/IVDR actors and devices; ISZP national notifications for distributors, service persons, custom made manufacturers, repackaging/relabeling reports (MDR Art. 16(4)) and Art. 82 trial notifications; RZPRO transitionally for manufacturers/importers seated in CR, clinical investigation applications (Art. 62/74), device notification and FSC · verifiedHighlights: The current national basis is Act No. 375/2022 Sb., effective 22 December 2022.; Distributors, service persons and custom made manufacturers have national ISZP notification duties.; RZPRO still carries manufacturer/importer agendas, sponsor registration and FSC issuance pending EUDAMED.

Since 7 March 2024 SÚKL runs device regulation agendas in two national systems: ISZP for distributor, service person and custom made manufacturer notifications, repackaging/relabeling reports (MDR Art. 16(4)) and other clinical trial agendas; RZPRO (legacy register under former Act 268/2014 Sb.) still carries agendas of manufacturers and authorised representatives seated in the Czech Republic, importers, clinical trial sponsor registration and issuance of free sale certificates, pending full EUDAMED functionality.

The Danish Medicines Agency operates a national exemption scheme under MDR Article 59 / IVDR Article 54 allowing a specific device to be marketed/used in Denmark without conformity assessment, for a limited period, to protect public health or patient safety. Only the manufacturer, its authorised representative, or a person/company authorised by the manufacturer may apply. The application must include a statement from a Danish health professional on the need and consequences for public health, an overview of Danish recipients, device types/models, number of units, the period needed, and a list of alternative devices on the market and/or alternative medical procedures which the health professional must consider.

A manufacturer of class I devices or IVDs domiciled in Denmark (and a Danish authorised representative for a non EU/EEA manufacturer) must notify the Danish Medicines Agency of company name, address, CVR number, phone, e mail and the types of devices marketed; the same duty applies to Danish producers of systems/procedure packs and sterilisers of CE marked devices. Changes, including cessation, must be notified. Notification is via digital e forms on DKMA's website and the data goes into an electronic register used for market surveillance.

Manufacturers of class IIa, IIb and III devices marketing or dealing in Denmark, and authorised representatives established in Denmark for such manufacturers, must notify the Danish Medicines Agency of name, address, CVR, phone, e mail, functions and device types. DKMA registers the information in a digital register and publishes a bruttoliste (gross list) of the companies on its website; the list is used for health professionals' applications/notifications of industry collaboration under sundhedsloven § 202a. Changes and cessation must be notified.

submissionSurface: EUDAMED (manufacturers, importers, authorised representatives) plus Danish national registration for distributors and specialty retailers · verifiedHighlights: From 28 May 2026, manufacturers, importers and authorised representatives register via EUDAMED only; only Danish established distributors and specialty retailers must register with the Danish Medicines Agency.; National registration is done via portal.dkma.dk/mudregistrering using MitID Erhverv; DKMA processing takes up to 14 days but the registration is valid and fee liable from the date the form is submitted.

statement: Obtaining a sanitary registration (registro sanitario) is obligatory for the manufacture, production, import, packaging, storage, transport, promotion, distribution and use of sanitary products in the Dominican Republic; DIGEMAPS evaluates the application and issues a certificate. · sourceApproval: none · targetJurisdictionId: dominican republic · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: The simplified procedure is available for new registrations and renewals of existing registrations, and also for modifications to a manufacturer's installations, substantial changes to the technical data sheet, changes to packaging and conditioning materials, changes to the product information system, changes to the manufacturing and control process, and changes to excipients that do not affect bioavailability. It is not a separate marketing authorisation: it is a procedural track within the sanitary registration. · sourceApproval: none · targetJurisdictionId: dominican republic · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

No sanitary registration is required for: (a) custom made (sobre medida) devices; (b) devices used for research in a scientific setting without commercialization purpose; (c) accessories/components/parts and spares that are integral to a registered device, described in its insert, not sold independently and without their own intended use; (d) software that controls or drives a hardware device without an independent medical purpose or integral to its operation. The 2026 norm adds (e) repowered/remanufactured devices.

Devices may be registered under one sanitary registration when they share the same device type, risk level, product owner, manufacturer and intended use; IVDs additionally require the same analytical methodology and analyte group. Sets/kits combining two or more devices for a specific treatment/diagnosis are registered under one number if packaged together; the kit expiry date is that of the component with the shortest shelf life and the kit risk class is that of the highest risk component.

Manufacture, import, dispensing and marketing of medical devices require a sanitary registration (registro sanitario) granted by ARCSA; the certificate is issued in the name of a registration holder (titular del registro sanitario) and the device obtains a unique national number enabling nationwide marketing. Applications are filed per device through the VUE of the ECUAPASS portal.

Two registration routes exist: (1) ordinary inscription (inscripción general), and (2) simplified inscription (proceso simplificado) based on recognition of registrations from high vigilance IMDRF member agencies, which uses a homologation form, a 30 day ARCSA evaluation, and requires the remaining ordinary dossier requirements to be filed within 30 days after approval via a modification request (otherwise the registration is cancelled).

Non sterile devices can be registered as a bundle when they share the same legal manufacturer, classification, generic proprietary name, common intended use and similar or close design, within permissible variants; raw material, GMDN and patient population need not match. A group of devices working complementarily can be registered as a system with a single number.

For non sterile Class IIa, IIb, III devices an initial registration file (Declaration of Conformity, CE certificate, ISO 13485:2016, free sale certificate) can secure a temporary acceptance number and importation approval; companies get 18 months from acceptance to complete the full file, with the first 6 months for the main documents and a one year import grace after the final acceptance number.

Locally manufactured medical devices of factories holding ISO 13485:2016 but no CE certificate follow guideline EDREX:GL.CAMD.009/010; the factory must apply GMP in accordance with Central Administration of Operations (CAO) procedures, and trading is not permitted until registration procedures are completed.

Imported and local medical devices holding international quality certificates (CE, ISO 13485, FDA CFG etc.) are registered under guideline EDREX:GL.CAMD.002 (v2, effective 09/2025), with separate procedures for sterile devices and for non sterile Class IIa, IIb and III devices.

Devices are registered under a single registration number only if they share trade name, GMDN or UMDN code, classification, intended use, manufacturer, raw materials and age group (size differences excepted); sutures with different raw materials still get one license.

Any undertaking that places a custom made device on the market must notify Ravimiamet of its intention at least ten days before making that device available on the market.

A health care provider, or a research and development institution, university or evaluated professional higher education institution that manufactures devices in house under MDR Article 5(5) or IVDR Article 5(5), must publish the list of those devices on its website and submit the list to Ravimiamet within ten working days of publication on the website.

EFDA operates four device marketing authorisation routes. (1) Full assessment for all non exempt devices that are neither low risk listed nor SRA/prequalified: a complete dossier filed under GDL/097 (non IVD) or GDL/087 (IVD). (2) The SRA/prequalified route under GDL/046 §9.4 for devices approved by a listed stringent regulatory authority or prequalified by WHO/UNFPA. (3) The low risk route under GDL/092 for Class I non IVD and Class A IVD devices on the published low risk list, where EFDA permits abbreviated assessment or approval by notification procedure. (4) Devices on the 'Guideline for Importation of Medical devices Exempted from Registration' are outside registration altogether.

Manufacturers of class I devices (other than custom made or investigational) self declare conformity by issuing the EU declaration of conformity (Art. 19) after drawing up the Annexes II III technical documentation; no notified body is involved. For class I devices placed on the market in sterile condition, with a measuring function, or that are reusable surgical instruments, Annex IX Chapters I and III or Annex XI Part A apply, with notified body involvement limited to the sterility/measuring/reusability aspects.

class III: Conformity assessment per Annex IX (including EU technical documentation assessment of design), or alternatively Annex X (type examination) coupled with Annex XI (Art. 52(3) MDR) · class IIb: Annex IX Chapters I and III including technical documentation assessment of at least one representative device per generic device group (for most class IIb implantables: every device); or Annex X coupled with Annex XI (Art. 52(4) MDR) · class IIa: Annex IX Chapters I and III including technical documentation assessment of at least one representative device per category; or Annexes II III documentation with Annex XI Section 10 or 18 (Art. 52(6) MDR)

Manufacturers of class A IVDs (other than performance study devices) self declare conformity by issuing the EU declaration of conformity (Art. 17 IVDR) after drawing up the Annexes II III technical documentation; if placed on the market in sterile condition, Annex IX or Annex XI applies with notified body involvement limited to establishing, securing and maintaining sterile conditions.

class D: Annex IX Chapters I, II (except Section 5) and III; self testing and near patient testing devices additionally follow the Section 5.1 technical documentation assessment; companion diagnostics require notified body consultation with a medicinal products authority or EMA (Art. 48(3) IVDR) · class C: Annex IX Chapters I and III including technical documentation assessment (Sections 4.4 4.8) of at least one representative device per category; alternatively Annex X coupled with Annex XI except its Section 5 (Art. 48(7) (8) IVDR) · class B: Annex IX Chapters I and III including technical documentation assessment (Sections 4.4 4.8) of at least one representative device per category (Art. 48(9) IVDR)

An operator distributing devices to retailers, health and social care actors or other professional users and making devices available on the Finnish market must notify Fimea of its activity and devices before making them available, and must annually (and on Fimea's request) supply information identifying the devices it makes available.

All distributors making available in Finland devices they have imported that are intended for self testing, or devices incorporating human tissues or substances derived from human blood or blood plasma, must notify Fimea with their name and place of business, the devices and their classification, identification data, a copy of the EU declaration of conformity and notified body certificate, instructions for use, and labelling information.

Health care units may manufacture devices in house only under MDR/IVDR Art. 5(5); Finland additionally requires a responsible person who approves each device before use, a signed declaration of compliance kept available to Fimea for five years from first use, prohibits reprocessing of single use devices and manufacture of specially risky devices, and requires prior notification to Fimea (49 § 7 mom).

Operators established in Finland (manufacturers, custom made device manufacturers, system/procedure pack assemblers, sterilisation service providers, authorised representatives, importers) and distributors making devices available in Finland must notify Fimea before placing devices on the market or making them available; notifications go into the national CERE register via Fimea e services or into EUDAMED for Finland established operators.

For MDR/IVDR manufacturers and importers, the national notification duty (49 § 1–2 mom) applies until the European database (EUDAMED) is functional and the operator has registered itself and its devices there in accordance with the regulations.

ANSM publishes, and updates quarterly, a national list of the persons responsible for placing custom made medical devices on the French market who made the national declaration (name, address, therapeutic domain; xlsx dated 21/05/2026).

submissionSurface: CE conformity under MDR plus registration in EUDAMED (Actors and UDI/Devices modules mandatory since 28 May 2026; directive era/legacy devices must be registered before 28 November 2026), plus a French national activity declaration to ANSM for distributors, custom device manufacturers and sterilisers · caveat: National declaration submitted with the ANSM form to communications.dm@ansm.sante.fr; urgent SRN requests for vigilance to contact.eudamed@ansm.sante.fr

France prohibits reprocessing of single use devices referred to in Article 17 of Regulation (EU) 2017/745, and prohibits their placing on the market and their use (national opt out from the MDR reprocessing option).

Where a Georgian marketing authorisation is required, the Law on Medicines provides exactly two regimes: the recognition regime of state registration and the national regime of state registration. The recognition regime applies to a product already authorised for the respective market by a foreign or international pharmaceutical product regulator on the Government list; the national regime requires the full dossier of Art. 11^11. For the device type categories this is the only registration pathway, and it is a local application whichever regime is used.

A DiGA is a CE marked medical device of risk class I or IIa under MDR; it can be prescribed by physicians and psychotherapists and reimbursed by the statutory health insurance only if it has successfully passed the BfArM review procedure and is listed in the directory of reimbursable digital health applications (requirements defined in § 33a SGB V).

Products had to be notified in the German Medical Devices Information and Database System (DMIDS) until the mandatory use of EUDAMED from 28 May 2026 (transition provisions § 96 and § 96a MPDG); legacy devices were also notifiable in DMIDS; automatic data transfer from DMIDS to EUDAMED is not possible.

From 28 May 2026 newly placed products are registered exclusively via EUDAMED, and products already on the market that continue to be placed on the market after 28 May 2026 must be registered in EUDAMED by 28 November 2026; products not registered by then may no longer be placed on the German market.

submissionSurface: EUDAMED (mandatory from 28 May 2026 for new devices; legacy devices by 28 November 2026); DMIDS served as the national registration surface under § 96/96a MPDG until 28 May 2026 and is being frozen as an archive · verifiedHighlights: From 28 May 2026 EUDAMED registration suffices for placing a product on the German market; no additional national notification required.; DMIDS capture of new product notifications was deactivated on 28 May 2026.

FDA Ghana processes new, renewal and variation applications for Class I to IV medical devices; separate application forms exist for registration of Class I devices and Class II IV devices.

A separate application is required for each single medical device, or for a medical device group, medical device family or medical device system.

No person shall manufacture, prepare, import, export, distribute, sell, supply or exhibit for sale a medical device unless it has been registered by the Authority.

Importers/distributors of medical devices must, before placing devices on the Greek market, notify the device data to the National Electronic Register of Medical Devices (Εθνικό Ηλεκτρονικό Μητρώο Ι/Π GREMDIS, services.eof.gr/gremdis). Required documents: CE marking certificate (higher risk classes) or competent authority registration certificate of the EU member state of registration (low risk classes), manufacturer's Declaration of Conformity, outer packaging, and instructions for use.

Manufacturers with seat in Greece placing devices on the Greek market under their own name, and Greek authorized representatives of manufacturers outside the EU, must register in the EOF Electronic Manufacturers' Register (Μητρώο Κατασκευαστών ΕΟΦ / GREMDIS). Under the MDR transition, Class I, custom made and IVD manufacturers had to (re)register / submit a modifying application with the new Declaration of Conformity (Art. 19, Annex IV MDR) by 25/05/2022, while EUDAMED was not operational; registration in the EOF national register continues in parallel with EUDAMED.

submissionSurface: EUDAMED plus EOF national medical device register (GREMDIS, services.eof.gr/gremdis) and EOF forms for applicable national duties · verifiedHighlights: EOF publishes current medical device supporting documents and forms.; EOF separately maintains medical device notification, vigilance and distribution/production materials.; National register surface verified on EOF e services page: 'Εθνικό Μητρώο ιατροτεχνολογικών προϊόντων' at services.eof.gr/gremdis.

In vitro diagnostic reagents take a separate but structurally identical route: the Inscripción Sanitaria under Norma Técnica Número 40 versión 3 2015, again a single inscription with no abridged or recognition variant. IVDs are divided into three health risk categories (I low, II medium, III high) that determine applicable requirements rather than the pathway.

Medical devices reach the Guatemalan market through a single pre market route: the Inscripción Sanitaria governed by Norma Técnica 37 versión 5 2016, which yields a Certificado de Inscripción Sanitaria. The national trámites catalogue records it as one procedure (3361) at Q 100, with no class specific, accelerated or reference authority variant; a device's class determines whether physicochemical and microbiological analysis is performed, not which pathway is used.

Applications are processed under the Expedited Approval Scheme when the applicant is an LRP with a valid listing, no associated deaths or serious injuries or active recalls/FSCA/AEs locally and worldwide, and all devices have two or more valid independent marketing approvals; participation is default with opt out.

The current market access surface is the voluntary MDACS listing: traders and Class II/III/IV general medical devices and Class B/C/D IVD medical devices may be listed; Class I GMD and Class A IVDMD are outside listing scope.

The Novo Lane prioritises processing of innovative medical device applications; qualifying criteria include first of its kind devices, innovation channel approvals (e.g. NMPA innovation list or FDA de novo) within the preceding 5 years, AI features approved within 5 years, or core technology patented within 5 years.

Listing applications follow Pathway 1 (conformity assessment by a recognised Conformity Assessment Body leading to a Conformity Assessment Certificate) or Pathway 2 (marketing approval documents from recognised regulatory jurisdictions).

Manufacturers of custom made devices must register in NOR; the duty has applied since 26 May 2021 independently of NEAK (health insurance) accounting, and manufacturing activity cannot be lawful without registration.

A distributor established in Hungary must notify the authority (NNGYK) before starting to distribute devices on the Hungarian market; distributors are registered in the national register NOR, not in EUDAMED.

Until NNGYK officially declares each EUDAMED module functional, use of the EUDAMED Actor registration module is mandatory in Hungary for the registration of economic operators, fulfilling 4/2009 EüM rendelet 17. § (1), MDR Article 31, 8/2003 ESzCsM rendelet 7/A. § (1) and IVDR Article 27.

IVD notification/registration under 8/2003. (III. 13.) ESzCsM rendelet 7/A. § uses an official notification form with attachments that vary by IVD tier; for general IVDs the manufacturer's declaration of conformity per Annex 3 of the decree must be attached.

Manufacturers and authorised representatives established in Hungary are entered in the national device register (NOR): this covers manufacture of Class I and custom made devices, assembly of systems and procedure packs, and sterilization, with a Class I declaration of competence; OGYÉI enters the data into EUDAMED. An administrative service fee is payable for the registration.

Manufacturers of devices other than custom made devices, authorised representatives and importers must register in the electronic system for operator registration under Chapter III of the Regulations; Lyfjastofnun confirms the registration and issues a unique registration number (SRN). Distributors are not in that system: they must register with Lyfjastofnun itself under rules the agency sets. Distributor registration is a charged, fee bearing act under Article 39 of the Act.

Lyfjastofnun states that importation of medical devices is conditional only on the device being lawful on the European market and in Iceland; beyond that, importation is free. There is no Icelandic import licence, import registration for the device, or pre shipment clearance. Operators who import from within the EEA are distributors for the purposes of the Regulations and do not register in EUDAMED as importers.

There is no Icelandic register of individual medical devices and no national device registration or device approval filing. Lyfjastofnun states on its operator guidance that it does not keep a register of individual medical devices. Market access therefore rests entirely on conformity with the Regulations (CE marking plus EU declaration of conformity), not on an Icelandic registration number for the device.

Class A devices that are non sterile and non measuring are exempt from the licensing regime: manufacturer and importer register them on the Online System for Medical Devices with self certification (essential principles checklist, standards) and, for importers, a plant registration or free sale certificate.

CDSCO notices fix the start of the licensing regime for all Class A and B devices at 1 October 2022 and for all Class C and D devices at 1 October 2023, following the G.S.R. 102(E) registration transition.

Route depends on class and origin: Class A/B manufacture licensed by the State Licensing Authority (Forms MD 3/MD 4 to MD 5/MD 6); Class C/D manufacture and import of all classes licensed by the Central Licensing Authority (Forms MD 7/MD 8 to MD 9/MD 10; import MD 14 to MD 15); Class A non sterile non measuring devices follow Chapter IIIB registration instead of licences.

Certain home use class A devices qualify for an 'izin edar notifikasi' (notification marketing authorization) with simplified requirements. 'Certain class A' means home use devices usable independently without special skill/health personnel, that are not sterile and not IVDs. PKRT classes 1 and 2 have an analogous notification route.

Health supplies (including all medical devices and PKRT) may only be placed on the market after obtaining the business licence in the form of an izin edar (marketing authorization); the licensed product must meet safety, efficacy/benefit and quality criteria.

The local licence holder (imported products: appointed Indonesian distributor/PAK; domestic: producer) applies for izin edar by class based evaluation through the Kemenkes e Regalkes portal (regalkes.kemkes.go.id), after OSS RBA business licensing; izin edar certificates and rejection letters are issued digitally.

Domestic manufacture of a device requires a manufacturing license (پروانه ساخت) under the 'دستورالعمل صدور و تمدید پروانه ساخت تجهیزات و ملزومات پزشکی'; for risk classes A and B the whole application, tracking and issuance process is electronic.

Placing imported devices on the market runs through the registered Iranian importing company: the directorate requires identification (شناسه‌گذاری) of all medical equipment by importing companies; until identification is done the item's IRC is deactivated, hidden from the imed.ir site, and removed from the list sent to the Central Bank for currency allocation.

submissionSurface: IMED portal (imed.ir) of the IFDA General Directorate of Medical Equipment & Supplies for company/product/import processes; TTAC (ttac.ir) for identity, registration codes and track and trace; class A/B manufacturing license applications are filed electronically via imed.ir with university food and drug deputies. · verifiedHighlights: The national medical device operational surface is the IMED portal, with TTAC as the FDA wide identity/track and trace system.; License application, tracking and issuance are fully electronic. · caveat: The imed.ir homepage content served during review is dated 1401 (2022); current generation portal URLs (e.g., import.imed.ir) could not be opened for https verification.

If the successful bidder's medical appliances are not registered in Iraq at the time of contract signing, the contract becomes effective only on the date the Certificate of Registration is obtained; the Minister of Health may exclude the successful bidder from submitting the registration certificate upon signing, in which case the contract is valid; the Contracting Entity must at all times cooperate to facilitate registration (ITB 7.4.1).

The Registration Department (قسم التسجيل) within MOH Technical Affairs Directorate handles registration of companies and (drug) preparations and accreditation of scientific offices, with the processes being automated into an electronic system.

KIMADIA announced that approval was obtained to add a clause to the model tender documents (Bid Data Sheet point 8) requiring medical and service equipment companies to register their production (manufacturing) sites by 31/12/2025, after which unregistered companies will not be allowed to participate in medical and service equipment tenders.

Under the MOP standard bidding document (ITB 7.4): unless the Bid Data Sheet stipulates otherwise, the medical appliances to be supplied under the contract must be registered with the competent authority in Iraq; a bidder already holding registration submits a copy of the Registration Certificate with its bid, and otherwise the successful bidder must submit at contract signing either the certificate or evidence of compliance with all documentary registration requirements specified in the Bid Data Sheet; exclusion from registration is permissible under the Minister of Health's powers.

For IVDs, Irish established manufacturers, authorised representatives, importers and distributors must all notify HPRA (name and place of business; manufacturer details for importers; device category); health institutions with in house IVDs (reg. 4) and manufacturing facilities (reg. 5) notify separately.

Manufacturers established in Ireland must notify HPRA of their name, registered place of business and a device identifying description; manufacturers designating an Irish authorised representative, and authorised representatives established in Ireland, must notify HPRA likewise and furnish evidence of the designation (S.I. No. 691 of 2021 regs. 3(2) (4)).

Declaration track (מסלול רישום בהצהרה), launched 3.9.2023: self declaration by the registration holder and/or importer for low risk (Class I incl. Is/Im/Ir) devices and low risk IVDs that are registered and marketed in recognized states only; the register registration certificate is sent immediately after the application is accepted in the registration system, and no later than 48 hours. It is the first stage of the 'Enabling Regulation' (רגולציה מאפשרת) programme.

Fast track (מסלול רישום מהיר), launched 2.6.2024 as the second stage of the 'Enabling Regulation', with two channels: fast 1 (ערוץ מהיר 1) — Class II with FDA approval (510(k)/De Novo), EU Class IIa with a recognized state approval, or IVD Self Test (IVDD)/class B (IVDR), all requiring 4 months of marketing; new registrations handled within up to 45 working days and renewals within up to 10 working days. Fast 2 (ערוץ מהיר 2) — EU Class IIb or IVD LIST B (IVDD)/class C (IVDR) relying on registrations from two independent regulatory authorities (e.g. EU and FDA) with 6 months of marketing; new registrations and renewals handled within up to 60 working days. Change applications in the fast track are also open to Class III and high risk IVDs (non substantial changes up to 10 working days; the substantial change option does not exist for Class III). Requires a lawyer affirmed affidavit (תצהיר מאומת ע"י עו"ד); the channel is chosen by the highest classification in the application file.

Regular track (מסלול רגיל): the standard route for new, renewal and change applications, with a published handling target of 120 days. Track choice is by product risk class; Israeli manufacturer devices registered and marketed in a recognized state may also use the fast track.

Manufacturers placing custom made devices on the Italian territory must communicate to the Ministry of Health their identifying data and the list of the devices. Data changes must be updated within 30 days and activity cessation communicated within 30 days (Art. 7(2) (3)); modalities are set by Ministerial decree (Art. 7(4)).

Registration surface is EUDAMED: manufacturers, authorised representatives and importers must register in the EUDAMED economic operator system before placing a non custom device on the market (Art. 12(1)); the Ministry of Health verifies the data entered and issues the Single Registration Number (SRN) through the electronic system (Art. 12(3)). A national database (banca dati nazionale) at the Ministry additionally covers distributor registration (Art. 14(1)) and SSN facing data. Ministry page: EUDAMED UDI/Devices registration module available on voluntary basis since 4 October 2021.

Approval applications (new and partial change), except Cabinet Order designated exceptions, are submitted through PMDA (機構を経由).

MHLW designated 高度管理医療機器/管理医療機器/IVDs (指定高度管理医療機器等) are certified product by product by a registered certification body (登録認証機関); foreign manufacturers market through a Japan MAH they appoint (選任製造販売業者).

A foreign manufacturer of approval route devices exported to Japan may itself hold the approval (外国製造医療機器等特例承認, Art. 23 2 17): MHLW grants approval product by product for marketing through a Japan MAH the foreign manufacturer appoints (選任製造販売業者).

Route depends on class/designation: Class III/IV (高度管理医療機器) and non designated products require product by product MHLW approval (承認, Art. 23 2 5(1)); MHLW designated products (mainly Class II 管理医療機器 and designated IVDs, some Class III) require third party certification (認証) by a registered certification body (Art. 23 2 23(1)); remaining Class I (一般医療機器) need only prior notification (届出, Art. 23 2 12(1)). QMS conformity assessment applies separately.

Devices and IVDs outside the approval and certification designations (i.e., Class I 一般医療機器 and non designated IVDs) are marketed after a prior product notification (届出) to MHLW by the MAH.

No device/supply, sterilant or disinfectant subject to testing may be circulated until it passes testing and circulation is approved by decision of the JFDA Director General; this covers tested registered items, unregistered items selected for testing, imported batches (including those arriving as donation/gift), and every medical gas batch.

The Import Section of the Medical Devices and Supplies Directorate processes: import of registered supplies with or without testing (تحلل / بدون تحليل), import of unregistered supplies with testing, import of samples for registration purposes, completion of customs declarations, personal import of supplies and devices, re export, and export for repair and return.

submissionSurface: JFDA Medical Devices and Supplies Directorate — Registration Section (قسم تسجيل الأجهزة الطبية والمستلزمات): registration as circulation authorization (إجازة تداول) of supplies/sterilants/disinfectants, renewal of registration, variations, free sale certificates and sample analysis · verifiedHighlights: Registration (circulation authorization), renewal, and variation services for supplies, sterilants and disinfectants are assigned to the Registration Section.; Sample analysis against approved technical specifications is also performed by the Registration Section. · caveat: Not published

By decision of the authorized body a device may be registered under an accelerated expertise procedure.

Under EAEU Council Decision № 46 the applicant selects one reference state (which performs registration and expertise) and at least one recognition state; the registration certificate is valid on the territory of the member states selected and recognized.

Kazakhstan operates a national state registration, re registration and dossier amendment procedure, performed by the state body via the e Government portal (www.egov.kz, www.elicense.kz) with EDS signed electronic documents, on the basis of expertise conducted per Order ҚР ДСМ 10.

From 01.01.2026 a pilot composite state service registers medicines and medical devices on a 'single window' principle in all regions; the pilot joint order applies to relations from 01.01.2026 and is valid until 31.12.2026.

A Class B medical device that has obtained at least two reference regulatory agency approvals for a labelled use identical to that intended for marketing in Kenya qualifies for the abridged evaluation route.

A Class C or D medical device qualifies for the abridged evaluation route if it has obtained at least three reference regulatory agency approvals for a labelled use identical to that intended for marketing in Kenya at the time of submission.

Class A medical devices are registered through a listing type review: documents are submitted via the PPB online portal (prims.pharmacyboardkenya.org), the application fee is charged immediately, PPB reviews the submitted data set, may issue input requests, and only applications satisfying the registration requirements are registered and listed.

A Class B device may use the EBR route if it: (1) has approvals from at least two of PPB's independent reference regulatory agencies for an identical labelled use; (2) has been marketed for at least three years in those agencies' jurisdictions; and (3) has had no safety issues globally in the last three years (no reported deaths, no reported serious deterioration in health, and no open field safety corrective actions including recalls at the point of submission).

A Class C (or D) device may use the ECR/EDR route if it either: (a) has approvals from at least three of PPB's independent reference regulatory agencies for an identical labelled use AND has been marketed for at least five years in those jurisdictions AND has no safety issues globally in the last three years (no deaths, no serious deterioration, no open FSCAs); or (b) has approvals from at least five of PPB's independent reference regulatory agencies.

Class B medical devices have four evaluation routes: Full Evaluation, Abridged Evaluation, Expedited Class B Registration (EBR) and Immediate Class B Registration (IBR). Class C and D and IVD medical devices have three: Full Evaluation, Abridged Evaluation, and Expedited (ECR for Class C, EDR for Class D). Devices without prior approval from any reference regulatory agency are subject to the full evaluation route.

A Class B device may use the IBR route if it: (1) has approvals from at least three of PPB's independent reference regulatory agencies (HC, MHLW, USFDA, TGA, EU NB, SWISSMEDIC, HPRA) for an identical intended use; (2) has been marketed for at least four years in two of those jurisdictions; and (3) has no safety issues globally in the last three years and no rejection/withdrawal by any reference agency or Kenya. Devices are registered immediately and listed in the PPB Online registry within an hour, with email notification within 48 hours of submission; PPB verifies documents post registration.

All medical devices including in vitro diagnostic medical devices must be registered with PPB prior to placing them on the Kenyan market, unless exempted by the Regulations.

statement: For in vitro diagnostic medical devices, the Latvian notification procedure applies to class B, C and D devices as well as to A list, B list and self test IVDs: the notifier files the notification form (Annex 1 to Cabinet Regulation No. 582) with the State Agency of Medicines and attaches a copy of the EU declaration of conformity and copies of valid notified body certificates. · sourceApproval: · targetJurisdictionId: · edgeType: · marketAccessStrength: · regulatoryLayer: · localApplicationRequired: Yes · targetDecisionRetained: No

statement: An economic operator who in Latvia starts placing on the market class IIa, IIb or III medical devices files a completed notification form (Annex 1 to the regulation) with the State Agency of Medicines, attaching a copy of the EU declaration of conformity and copies of the valid notified body certificates. One notification covers the devices of one manufacturer contained in one certificate. The agency publishes the notification data within 10 working days and the procedure is then complete; the notifier may then place the device on the market without an agency decision. · sourceApproval: · targetJurisdictionId: · edgeType: · marketAccessStrength: · regulatoryLayer: · localApplicationRequired: Yes · targetDecisionRetained: No

Every manufacturer, importer or distributor of medical devices must address an application for registration to the Ministry of Public Health / health technology unit before any placing on sale. The application is made in two copies and must include the LNDM identification sheet printed from the MOPH online system, the conformity documents, the labelling and the user manual.

Anyone making custom made devices (MDR Art. 2(3)) available on the market in Liechtenstein must declare to the Amt für Gesundheit before supply: name and address of the manufacturer and all manufacturing sites; where applicable name and address of the authorised representative; and the codes needed to identify the production categories per MDR Art. 42(13). Changes must be reported within 30 days; the Amt für Gesundheit may exempt low risk products from the duty.

Health institutions manufacturing and using products in house (MDR Art. 5(5)) must declare to the Amt für Gesundheit before putting them into service: their name and address, name and intended purpose of the product, and its risk class per MDR Annex VIII. EWR IvDV Art. 14 contains the identical duty for IVDs (per IVDR Art. 5(5) and Annex VIII). Changes are reportable within 30 days and the Amt für Gesundheit may exempt products by risk.

Medical devices may be placed on the market in Liechtenstein if they comply with EEA Agreement Annex II Chapters X and XXX, in particular Regulation (EU) 2017/745 (CE route); EWR IvDV Art. 7 states the parallel rule for IVDs under Regulation (EU) 2017/746. On top of the EU route, national notifications to the Amt für Gesundheit apply (custom made devices, health institution products, IVD first import reports).

For the Swiss customs union channel, economic operators with seat in Switzerland or Liechtenstein register with Swissmedic (Art. 55 MepV / Art. 48 IvDV), and product registration for all products placed on the market in the customs territory takes place at Swissmedic (Art. 17 MepV / Art. 16 IvDV / Art. 47 HMG); database information is provided to the Amt für Gesundheit on request.

Manufacturers, authorised representatives, importers and distributors placing on the Lithuanian market devices classified under Regulation (EU) 2017/745 as Class IIA, IIB or III, or custom made active implantable devices, must submit to VASPVT data on their establishment address and on devices placed on the Lithuanian market no later than 14 working days after the date of placing on the market.

submissionSurface: National registration/notification with VASPVT under HSL Art. 59 1: document submission for the registered categories (custom made, IVD, performance evaluation, Class I, systems/packs), written decision within 20 working days; for Class IIA/IIB/III and custom made AIMD actors, data notification within 14 working days of placing on the market; the EUDAMED based regime applies once Law XIII 2754 Arts. 5/10 take effect (2022 11 26 or 24 months after the Commission's EUDAMED functionality notice) · submissionChannels: Remotely, by electronic means through the contact centre, or applying directly, in the manner set by the Minister of Health or the authorised institution · caveat: The VASPVT 'Registravimas' page publishing the national forms is Cloudflare blocked to automated access (2026 08 25) and could not be opened to verify the current forms.

The EUDAMED era version of HSL Art. 59 1(4) extends the national data submission list to: Class I devices; systems and/or procedure packs; and systems and/or procedure packs that are sterilised (in addition to custom made, custom active implantable, IVD and performance evaluation devices).

Under the transitional regime of HSL Art. 59 1, market actors must submit to VASPVT data on devices defined and classified in Regulation (EU) 2017/745 or the IVD rules that are: custom made devices; custom made active implantable devices; in vitro diagnostic devices; and devices manufactured for performance evaluation purposes; registration is required before those devices may be placed on the Lithuanian market (Art. 59 1(6)).

Before placing a Class I medical device or an IVD on the market, the manufacturer or authorised representative established in Luxembourg must register the device with the Direction de la santé; registration in EUDAMED (mandatory use from 28 May 2026) is accepted as fulfilling this national requirement. The CA reserves the right to request supporting documents not available in EUDAMED (declaration of conformity, QMS certificate, IFU, labelling copy, in certain cases technical documentation).

Only devices registered (Class IIb and III) or filed (Class I and IIa) under Law 12/2025 may circulate in Macau: Class IIb/III go through registration with ISAF; Class I/IIa go through filing (備案) with 5 working day formal review.

Devices already circulating in Macau before the regime must be registered or filed within transition windows ending 2029 06 30 (Class III and IIb), 2030 06 30 (Class IIa) and 2032 06 30 (Class I).

Class A medical devices are exempt from the CAB conformity assessment procedure; new and re registration applications for Class A are submitted directly to MDA via MeDC@St.

From 1 June 2026, specified medical lasers used for aesthetic purposes (alexandrite 756nm, diode 800nm, Er:YAG, fractional CO2, Nd:YAG, pulse dye, ruby) are designated medical devices; no person may use or operate a designated device without a designated medical device permit under Act 737 (fine up to RM100,000 and/or 1 year imprisonment).

Registration is two stage: (Stage 1) conformity assessment by an MDA registered Conformity Assessment Body (CAB) covering QMS, PMS system, technical documentation and Declaration of Conformity; (Stage 2) application to MDA via MeDC@St with the CAB report and certificate. Registration requires completion of the CAB conformity assessment procedure.

No medical device may be imported, exported or placed on the Malaysian market unless it is registered under Act 737; contravention is punishable with a fine up to RM200,000, imprisonment up to 3 years, or both.

There is no Maltese pre market approval of a medical device. The pathway has two national steps on top of the CE conformity route: (1) organisation registration of the economic operator with the Malta Medicines Authority (form MT MDF02), and (2) notification of each device made available on the local market (form MT MDF05), with a Medical Device Registered Person registered separately (form MT MDF11). A device notification is submitted by economic operators with a registered place of business in Malta, or by operators with a place of business outside Malta that have no local supplier in Malta. The Authority describes organisation registration as existing to increase visibility and traceability and to enable communication between the operators and the Authority.

Annex 2 of the July 2025 Acuerdo lists 104 low risk device types that require no registro sanitario for production, sale or distribution and no import permit for entry; importers present at customs a declaration under protest that the product corresponds to Annex 2, and keep Aviso de Funcionamiento and Responsable Sanitario obligations; GMP and tecnovigilancia obligations still apply. Annex 3 lists 999+ products not considered medical devices.

ordinary: Class based registro sanitario filed on official format (national manufacture: RIS Art. 179; foreign manufacture adds RIS Art. 180 documents) · low risk simplified: Annex 1 of the 2025 low risk Acuerdo (93 items): registration with simplified requirements, resolved within 20 working days · exempt: Annex 2 (104 items): no registro sanitario required, no import permit required, but GMP and tecnovigilancia obligations remain · reliance: COFEPRIS 04 050: registration by equivalence with Autoridades Regulatorias de Referencia approvals (Lineamientos DOF 18 07 2025)

All medical device categories (equipos médicos, prótesis, órtesis, ayudas funcionales, agentes de diagnóstico, insumos odontológicos, material quirúrgico y de curación, productos higiénicos y otros dispositivos de uso médico) require a sanitary registration (registro sanitario) for production, sale and distribution; LGS Art. 376 excepts devices determined to be low risk that the sanitary authority exempts from registration.

The CE track procedure is carried out through the electronic service "personal cabinet of the authorised representative". Access is granted on the RSDM registration form, completed and electronically signed by the administrator or director of the authorised representative and sent to idm@amdm.gov.md; AMDM grants access or communicates the reason for refusal within 10 working days of receipt. Communication between the applicant and AMDM takes place exclusively through the e mail address of the delegated responsible person and through the device regulation and registration subdivision. The applicant notifies AMDM before placing the device on the market by completing the application in the personal cabinet, and the application counts as officially filed on the date the payment is confirmed through the Mpay system. The 10 working day examination period runs from the date the dossier is taken over by the AMDM expert in the system, when the dossier acquires the status "în proces de validare".

Devices may be included in a single dossier only if they cumulatively have the same intended purpose within the meaning of art. 2 of Legea nr. 102/2017, the same manufacturer and the same risk class; this follows art. 7 alin. (1) of the Law. Grouping devices in a dossier that do not meet those conditions cumulatively is an express ground for rejecting the dossier. Accessories are registered in a single dossier with the medical device for which they are intended. Duplication of an active registration in the RSDM is prohibited and is also a ground for rejection.

Registration of the manufacturer in the RSDM is a mandatory precondition of any application to register medical devices. The authorised representative files one application for each manufacturer with which it has concluded an authorised representation agreement, through the personal cabinet. The manufacturer registration application contains the complete name of the manufacturing company, identical to the one in the declaration of conformity and the authorised representation agreement, the manufacturer's single registration number (SRN), and the representation agreement attached as a PDF signed by the parties in handwriting or electronically. It is processed within 10 working days of filing; on acceptance the manufacturer becomes visible in the personal cabinet, and rejection is reasoned in fact and in law with the non conformities identified.

Moldova operates two distinct routes into the State Register of Medical Devices. CE marked devices go through the electronic notification and registration route governed by AMDM Order no. Rg04 264 of 08.09.2026, which is filed entirely online in the authorised representative's personal cabinet. Devices that do not hold CE marking go through the registration route governed by Ministry of Health, Labour and Social Protection Order no. 212 of 21.03.2018, which is filed on paper at the Agency's single window. AMDM publishes the two routes as two separate procedures on its medical devices section.

High and medium risk medical equipment and medical consumables are entered on the list by country of manufacture, manufacturer, model or product number individually. Nine categories of device do not require registration: low risk devices other than IIa/IIb/III equipment, consumables and IVDs; spare parts; IVDs supplied under an external quality assessment contract; rare disease IVDs; devices for research; registration samples; devices for exhibition; devices for use in a disaster or a serious public health situation; and devices received by international post or carried by a passenger for a citizen's personal use. The last four categories of exempt device may not be sold.

Devices manufactured in, imported into, supplied or sold in Mongolia must be registered, save for the statutory exemptions. The Agency grants the registration in two forms — state registration (улсын бүртгэл) or inclusion in the medical device list (эмнэлгийн хэрэгслийн жагсаалт) — taking into account the requirements of Arts. 15.3.1 (proven quality, safety and efficacy) and 15.3.7 (implementation of good reliance practice) and the fact that the device has been placed on the market in the country of manufacture, and on the basis of the Medical Devices Council's decision under Art. 51.1. High and medium risk laboratory diagnostic devices are registered in the state register for a period of five years on the basis of the manufacturer's request, the registration documents, an expert opinion and the Council's decision.

statement: The application for registration, for extension of the registration period, for amendment/supplement of registration data and for deletion from the register of medical devices is filed on the prescribed form: Form 1 (Obrazac 1) for Class I devices, Form 2 (Obrazac 2) for Class IIa, IIb and III devices, Form 3 (Obrazac 3) for in vitro diagnostic medical devices, and Form 4 (Obrazac 4) for active implantable medical devices (AIMD). · forms: Obrazac 1 — klasa I; Obrazac 2 — klasa IIa, IIb, III; Obrazac 3 — IVD; Obrazac 4 — AIMD

statement: Within 90 days of the submission of complete documentation the Institute enters in the register: the medical device, the manufacturer, the legal person carrying out wholesale and retail trade in the device, and the importer. If the application is incomplete the Institute invites the applicant in writing to remedy the deficiencies within 30 days, and the 90 day period does not run until the requested data and documents are supplied. · reviewClockDays: 90

statement: Registration of a medical device under the Law on Medical Devices is not a condition for placing the device on the market or putting it into service (Art. 37(2)). · sourceApproval: n/a

Placing a medical device on the Moroccan market requires a prior registration certificate (certificat d'enregistrement). The application is filed with the AMMPS/Ministry of Health by a manufacturing or importing establishment that has itself been declared to the administration. There is no separate notification only or self declaration route for registrable devices, and no abridged route keyed to a foreign approval.

Moroccan customs are instructed to make the import AND export of medical devices subject to presentation of a registration certificate or, as the case may be, a specific authorisation issued by the Direction du Médicament et de la Pharmacie, across all customs regimes including donations. Where the certificate cannot yet be presented, the importer is referred to that direction and customs release is conditional on one of: the registration certificate; a filing receipt for the registration dossier (attestation de dépôt du dossier d'enregistrement); or the duly visaed invoices. This is the operational form of the registration requirement: a pending application with a filing receipt is enough to clear a shipment.

Devices in six categories are outside the registration obligation and instead require a 'specific authorisation' delivered by the administration under conditions fixed by regulation: experimental devices imported or made locally for biomedical research; devices not marketed in Morocco that are prescribed to named patients; imported used devices intended for refurbishment and export; custom made devices; samples imported for evaluation with a view to registration; and samples imported or made locally for display at trade fairs, scientific congresses and exhibitions.

DFDA issues four pre market certificates: Manufacturing Licence and Product Registration Certificate for locally manufactured devices; Import Recommendation Certificate and Import Notification/Registration Certificate for imported devices.

134 categories of medical devices (e.g. adhesive bandage/tape/plaster for general use, ambu bag, autoclave, audiometers) are exempt from the DFDA import recommendation, per the official exemption list published 20 March 2019.

A local company applies to DFDA for a medical device import recommendation certificate (တင်သွင်းခွင့် ထောက်ခံချက်) before importing; documentation requirements are published separately per AMDD risk class (Class A, Class B, Class C/D lists).

If the device applied for is a Rapid Diagnostic Test Kit, an original recommendation from the National Health Laboratory must be attached to the import recommendation application.

submissionSurface: 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 · verifiedHighlights: Devices placed on the market on or after 28 May 2026 must be registered in EUDAMED before the first individual unit is placed on the EU market.; Devices placed on the EU market before 28 May 2026 must complete EUDAMED UDI/Device registration by 28 November 2026.; Products already notified in NOTIS but not in EUDAMED must additionally be registered in EUDAMED.

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.

Exempt from WAND notification (Schedule 1): devices that are also medicines; custom devices made to a registered health professional's design specification for a particular patient; devices supplied to a practitioner for a particular patient; devices held by NZ Customs pending export; IVDs used only within one laboratory; lab made tests supplied to another laboratory; personal use imports; devices imported for clinical trials; and classes declared exempt by Director General Gazette notice.

The Director General declared, under paragraph (i) of Schedule 1 and by notice in the New Zealand Gazette, that 'any diagnostic device that is commonly known as an in vitro diagnostic device' is an exempt class of medical device, effective 1 January 2004 — removing the mandatory WAND notification duty for IVDs.

For medical devices to be legally supplied in New Zealand they must be notified to the WAND database; notification is a mandatory requirement for importers, exporters and local manufacturers (sponsors) of non exempt devices.

route: notification · premarketApproval: No · description: No premarket approval or assessment system exists for medical devices under the Medicines Act 1981. Sponsors of non exempt devices must notify device information to the free WAND database within 30 working days of becoming sponsor. IVDs are exempt (voluntary notification only). Notification does not mean or imply the device has been assessed by Medsafe.

A sponsor who contravenes reg 6 (notification), reg 8 (updates), reg 9 (compliance procedures) or reg 10 (prohibited statements) commits an offence punishable on conviction by a fine not exceeding $500.

A Dossier Screening Clearance is a prerequisite for submitting registration applications for moderate and high risk (Class B, C, D) IVD and non IVD medical devices on NAPAMS.

After satisfactory documentation review, GMP inspection of the production facility and laboratory analysis (where applicable), products are presented to the Food and Drug Registration Committee (FDRC) for approval.

For imported devices, after document screening NAFDAC issues a Permit to Import electronically via the NAPAMS portal, authorizing importation of registration samples for laboratory testing/evaluation.

Device registration applications are submitted and processed on the NAFDAC Automated Products Administration and Monitoring System (NAPAMS) portal at https://registration.nafdac.gov.ng (previously described as the iRIMS portal in the baseline).

A separate application is required for each medical device, IVD, related product, device group, device family or device system; a separate application form is required for each product, product group, product family or system.

Registration applications are made on four prescribed forms: form No. 1 for class I devices, form No. 2 for class IIa, IIb and III devices, form No. 3 for in vitro diagnostic devices and form No. 4 for active implantable medical devices. Applicants may be a manufacturer, a legal representative of a foreign manufacturer under a representation contract, a branch of a foreign manufacturer, or a trade representation of a foreign manufacturer, each with a registered seat in the country and valid insurance covering the territory of the country.

Manufacturers of medical devices must report their activity to the Agency before starting manufacture and be entered in the register of manufacturers of medical devices; wholesale of medical devices may be performed only by legal entities entered in the register of legal entities for wholesale of medical devices; specialised shops performing retail of medical devices must be entered in the register of specialised shops for medical devices. Manufacturer entry requires data on premises, equipment, staff and the quality system, the address and Central Register certificate, a list of devices manufactured with their classification, data on design, quality control and maintenance, and proof of liability insurance.

MALMED keeps a register of manufacturers, a register of legal entities performing wholesale and retail circulation of medical devices, and a register of medical devices available on the market in the country. The content of the application form and the documentation for entry of a device in the register of medical devices are prescribed by the Director of the Agency. Entry is a national act: MALMED's register page states that the Agency keeps the register of medical devices on the territory of the country for which the appropriate approval for placing on the market has been issued, and the Law's penalty and parallel import provisions refer to the register entry number and to 'the procedure for entry of a medical device in the register of medical devices'.

A parallel import of medical devices may be performed only by a wholesale undertaking holding a wholesale authorisation issued by a competent authority in the country; a health institution may parallel import exclusively for its own needs. The applicant must hold a valid approval for parallel import of a medical device issued under the Law, and the device must already be entered in the country's register of medical devices and be in circulation there.

submissionSurface: EUDAMED · obligation: Manufacturers must register their devices in EUDAMED prior to placing the devices on the market in Norway/EU EEA. · transitionDeadline: Devices placed on the market before 28 May 2026 fall under a six month transition and must be registered by 28 November 2026.

Anyone with a business address in Norway who produces and markets medical devices in their own name (including as systems or procedure packs) must enter company name, organisation number, business address and data enabling unambiguous identification of the devices in a public device register (offentlig utstyrsregister).

Device registration runs through the MoH E Health portal service 'Register Medical Device' (service period 60 working days) with class based fees (A B: 100; C D: 200, Omani Rial per gov.om); DSC separately publishes device, manufacturer, e IFU, reporting, import and variation services/guidance.

Devices may be registered as Single, Family, System or Procedure Pack; a single registration application may include a maximum of 50 products; accessories may be included with the device unless marketed separately, and separately marketed members require another application.

Circular No. 161/2025 (published 6 July 2025) commenced registration of high risk (Class C&D) medical device and supplies manufacturers and their products; Class D device importation is subject to their registration by 01 07 2026. On 28/06/2026 DSC published a circular titled 'Extension of Registration Period for High Risk Medical Devices and Supplies Manufacturers and Their Products' extending that period (new end date is in a scanned PDF whose text is not machine readable).

GD1 establishes medical device listing: parties supply device identification information to the regulator, submitting all necessary information when the device is first supplied to the market; listing does not remove other regulatory obligations.

Before registering a medical device the applicant must hold: local medical device establishment approval, medical device manufacturer registration, a copy of the Medical Devices Manufacturer License, and a local agency certificate; GD3 also requires initial approval of wholesale activity. Required document: copy of the commercial agency certificate.

Under rule 14(1) an application for enlistment or registration of a medical device may be made only by (a) an establishment holding a valid licence to manufacture medical devices, or (b) an importer in his capacity as authorized representative in Pakistan holding a valid establishment licence.

Pakistan operates a two track market authorisation system under rule 13: Class A medical devices obtain enlistment, while Class B, C and D medical devices require registration.

Certificados de Criterios Técnicos valid at Ley 90's promulgation (issued under DE 468 de 7 Nov 2007) are treated as valid Registro Sanitario and Certificado de Criterio Técnico and keep their original validity; certificates issued after Ley 90 cannot be used as Registro Sanitario.

The Registro Sanitario de Dispositivos Médicos, issued by DNDM, authorizes import, export, marketing and public/private use of a device once the applicant demonstrates with documented evidence that the product meets safety, efficacy and quality characteristics defined in international norms. Devices do not require prior laboratory analysis at processing stage, save exceptions set by the health authority. Certificates may be issued per family, and for kits/trays/systems.

For class I, the classification is made by sworn declaration filed with the notification, following Annex II of Resolución DINAVISA N° 226/2024; for classes II, III and IV the responsible technician declares the class in the DINAVISAPy platform with a technical justification and DINAVISA may accept or reject it.

Registration applications for class II, III and IV medical devices (and their accessories), national or imported, are governed by Resolución DINAVISA N° 226/2024, which also governs post approval modifications and renewals. Imported class II IV applications are sorted by class and either take the simplified registration process (if authorised by a listed reference authority) or the integral analysis track that examines every item of Art. 6.

In vitro diagnostic products must hold a sanitary registration granted by DINAVISA for their manufacture, import, export, conditioning, distribution and commercialisation, and the applicant establishment must first be authorised in the corresponding line of business under MERCOSUR GMC Resolution N° 21/98 as internalised by Decreto N° 2885/1999. A technical director with a university degree in biochemistry is required.

Only holders of a sanitary authorization as a laboratorio (of pharmaceutical products, medical devices or sanitary products) or as a droguería may apply for the Registro Sanitario; a registration may be transferred to another qualifying party maintaining the same manufacturing installations and conditions.

Products manufactured in Peru exclusively for export are exempt from the Registro Sanitario requirement.

The 2026 MINSA TUPA includes dedicated procedures 'Inscripción/Reinscripción en el Registro Sanitario de Dispositivos Médicos de Diagnóstico In Vitro' (codes PA990002F5 and PA990033E4) for nationally or foreign manufactured IVDs, with 30 business day review.

All devices within the Article 6 classification require a Registro Sanitario, which authorizes manufacture, import, storage, distribution, marketing, promotion, dispensing, sale or use; the application is filed by class (I IV, plus IVD) before DIGEMID with declaration jurida application, free sale certificate (imports), quality system evidence and technical file.

An authorized droguería may obtain a Certificado de Registro Sanitario to import and market a device already registered by another holder (parallel import); DIGEMID issues it within 15 days, it expires with the parent registration, and the certificate holder assumes the same responsibilities and obligations as the registration holder.

Class A devices apply for Notification (Certificate of Medical Device Notification, CMDN); Classes B, C and D apply for Registration (Certificate of Medical Device Registration, CMDR, issued as Certificate of Product Registration).

Medical devices strictly for research, clinical trial, exhibit, and/or donated brand new medical devices are exempted from Notification and Registration, but the researcher, institution and/or user must apply for a Certificate of Medical Device Listing (CMDL).

Initial CMDN applications for Class A devices are filed online through the FDA eServices Portal System (eservices.fda.gov.ph); Class B/C/D devices require CMDR (initial applications for CMDN for B/C/D are no longer accepted) and IVDs follow the separate CPR for IVD route; unregistered products may not be marketed.

RA 3720 as amended by RA 9711 prohibits the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non consumer use, promotion, advertisement or sponsorship of any health product which, although requiring registration, is not registered with the FDA.

URPL issues free sale certificates (MDR Art. 60 / IVDR Art. 55) at the request of a manufacturer or authorised representative established in Poland, within 15 working days of application; the certificate is drawn up in Polish and English; the fee is 700 PLN (350 PLN for devices covered by the old directives during the transition); an application without proof of fee is left unprocessed.

Notifications made under the repealed 2010 Act continue under the old rules until EUDAMED registration becomes mandatory for the given entity (MDR Art. 123(3)(d)/IVDR Art. 113(3)(f)), with an 18 month grace period for manufacturers and authorised representatives not yet EUDAMED registered; URPL's registration page confirms importers may keep filing notifications under the previous rules in the interim. Data changes under legacy notifications must be reported to URPL until 1 January 2031.

After submitting registration data to EUDAMED (MDR Art. 31(1)/IVDR Art. 28(1)), a manufacturer or importer established in Poland — and a foreign manufacturer whose authorised representative is established in Poland — must apply to the President of URPL for the unique registration number (SRN, MDR Art. 31(2)/IVDR Art. 28(2)); URPL verifies the data against the Polish company registers before issuing. Applications are made on URPL Forms 1 4, in person, via ePUAP trusted profile, qualified e signature, personal signature or notarised signature.

Any manufacturer domiciled or headquartered in Portugal placing custom made devices on the market in its own name must notify INFARMED electronically.

Until EUDAMED is implemented and operational, manufacturers, authorised representatives, distributors and notified bodies must meet their national notification/registration duties under DL 145/2009 arts 9, 10, 11(1,2,3,5) (manufacturers/mandatários placing Class I, custom made, sterilisation or procedure pack devices) and 41(1)(b) (distributors); INFARMED operates the SIDM national registration system for this purpose.

MoPH operates an implantable medical device (IMD) registration route: an official application form with document checklist plus a dedicated Implanted Medical Devices Registration page and online portal (imdr.moph.gov.qa, access restricted externally). This fact is limited to that verified IMD route and does not characterize the route for other devices.

The official MoPH service catalog (Sharek, 10 pages, ~100 services) contains no product registration, listing, or import permit service for non implantable medical devices; the only device related services are facility device licensing, equipment safety assessment/technical evaluation, and customs port shipment inspection.

A Romanian established manufacturer placing custom made devices on the market under its own name must register at ANMDMR with registered office address and description of the devices, under the norms approved by OMS 2845/2022 (applying art. 13 OUG 46/2021).

Registration filings are made by email or in person at ANMDMR: the payment form to registratura@anm.ro (or at the headquarters), and the registration request after payment confirmation to drsp@anm.ro; address Strada Aviator Maior Ștefan Sănătescu 48, Sector 1, Bucharest.

The Romanian established producer or authorised representative placing IVDs on the market under its own name must register at ANMDMR, for IVD classes A, B, C and D, using the notification form of annex 1 to Ordin 3753/2023.

Romanian established manufacturers placing devices on the market under their own name (including systems and procedure packs under MDR art. 21(2)) must register at ANMDMR, giving registered office address and device description, for entry in the national device database (baza națională de date). Per the ANMDMR page this covers classes I, IIa, IIb and III, including sterile and/or measuring devices.

ANMDMR states that registration of devices in the national database does not represent an approval or authorisation from ANMDMR.

Registration of low risk devices on the deficit list approved by Government Decree No. 552 of 01.04.2022 is completed within no more than 5 working days; class 1 expertise fee 32,000 RUB applies.

A parallel EAEU common registration route exists alongside the national route, based on the EAEU Treaty of 29.05.2014, the Agreement on unified principles and rules of circulation of medical devices (23.12.2014) and other Union law instruments, plus member state legislation.

Devices may circulate in Russia only after state registration by Roszdravnadzor (national RU) or EAEU common registration. National routes from 01.03.2025: registration with clinical trials (≤50 working days), registration without clinical trials (≤31 working days), fast track for deficit list low risk devices (≤5 working days, Decree No. 552/2022), series/batch registration (Decree No. 430/2020), and a single expertise route for Russian manufactured devices via FGBU VNIIMT.

Rwanda FDA processes medical device applications through three routes. Notification applies to Class A devices that are non sterile, non active and without a measuring function, and results in a certificate of notification. Registration applies to all other devices and is assessed either through the abridged assessment procedure, where prior assessment and inspection outcomes from WHO prequalification or a competent NRA are taken into account, or through full assessment, which is a two assessor scientific and regulatory review of quality, safety and performance. Applications are submitted through the Rwanda FDA online portal. Priority assessment may be granted where the device is intended for diagnosis, treatment or alleviation of rare disease conditions, or in an emergency situation.

For low risk devices, only 6 items are submitted instead of the full Annex 3 technical documentation: (1) device description and specification, (2) information to be provided by the manufacturer, (3) essential principles checklist, (4) evidence of compliance, (5) risk management file, (6) PMS plan and report. SFDA may request the full technical documentation even after MDMA is granted; it must be provided within 10 days of the request.

Route is SFDA Marketing Authorization (MDMA): a device may be made available in the KSA only if registered at SFDA with an MDMA. After authorization the device is listed in the National Registry, which constitutes registration. Application may be filed by a local manufacturer, an overseas manufacturer, or the overseas manufacturer's Authorized Representative.

The device registration dossier is subject to administrative and technical evaluation, and the registration process results in a marketing authorisation for devices of class B, C and D. Class A devices are instead the subject of a declaration to the ARP on the basis of a conformity evaluation, with the declaration modalities fixed by decision of the ARP's Director General. The marketing authorisation for classes B, C and D is issued by decision of the ARP's Director General and is valid for five years, renewable. The list of devices subject to the homologation procedure is fixed by the ARP and must contain at least devices of classes B, C and D.

A certificat de mise en service is delivered by the pharmaceutical regulation structure before any use of high risk medical devices, notably those of classes C and D. This is a third authorisation, distinct from the marketing authorisation and from the import authorisation, and it gates clinical use rather than supply.

The import of any medical device, whatever its class of belonging, is subject to a prior authorisation from the pharmaceutical regulation structure; the ARP arrêté states that the import of any medical device is subject to an authorisation delivered by the ARP. Under the decree, registration, import, export, distribution and sale of devices are subject to an agreement from the regulation structure, while the manufacture of devices is subject to an authorisation delivered by order of the Minister in charge of Health. A device therefore needs both its marketing authorisation or declaration AND a separate import authorisation for each shipment or import operation.

Devices placed on the market must bear a CE marking or a Serbian conformity mark (Art. 17). Foreign certificates of conformity (certificate, test report, declaration of conformity, certificate of control issued by an EU notified body or accredited laboratory) and CE marking are recognised by ALIMS in the registration procedure; recognition may also be obtained as a separate procedure at the request of the manufacturer or authorised representative (bylaw Art. 3(2)). For non harmonised devices, the Serbian conformity mark is affixed following conformity assessment by an appointed (imenovano) body.

ALIMS registers in the Register of Medical Devices each medical device for which conformity assessment has been carried out and which is placed on the market or into use; the application is submitted before placing on the market. Art. 50(2) states that registration in accordance with the law is not itself a requirement for placing on the market; trade of a registered device is performed on the basis of a valid registration decision (registration bylaw Art. 11(6)), and a device without a submitted registration request is a ground for market ban and withdrawal (Art. 84(1)(7)).

Trade (promet) of a registered medical device is performed on the basis of the valid registration decision; if a renewal request was filed and the validity term expired, the last decision's validity is extended until the renewal decision, but at most 90 days from expiry, and trade continues on the extended decision plus the completeness confirmation.

Class A medical devices are exempt from product registration (reg 10B) but must be notified to HSA via a product notification application in SHARE (Class A database) before supply.

Class B, C and D devices are registered through Full, Abridged, Expedited or Immediate routes depending on prior approvals from HSA's overseas reference regulatory agencies and marketing history; Class A is only notified.

A person must not supply a health product (device) unless it is registered, except in prescribed cases; contravention is punishable by fine up to $50,000 and/or imprisonment up to 2 years.

From 28 May 2026 use of the first four EUDAMED modules becomes mandatory (Actor registration; UDI/Devices registration; Notified bodies and certificates; Market Surveillance). Actor registration moves to EUDAMED and manufacturers must register all devices in EUDAMED, but the national notification duty under § 110b is retained: the national dossier shrinks to documents not available in Slovak in EUDAMED (Slovak device name, Slovak IFU, Declaration of Conformity). The Class I / IVD class A exemption continues unless ŠÚKL requests notification. Distributor registration becomes mandatory at national level for distributors making devices available on the Slovak market regardless of seat.

Since 1 August 2023 ŠÚKL is designated to issue Certificates of Free Sale (Certifikát voľného predaja) for medical devices and IVDs under § 129 ods. 2 písm. aj) of zákon č. 362/2011 Z. z. (as amended by zákon č. 293/2023 Z. z.). Request in paper form at ŠÚKL's counter, by post, or electronically via www.slovensko.sk; certificate issued only in paper form in 3 copies; administrative fee 300 €.

submissionSurface: CE conformity under MDR/IVDR plus a national ŠÚKL layer: notification (oznámenie) of devices under § 110b ods. 2 zákona č. 362/2011 Z. z. (with assignment of a national ŠÚKL code); registration (registrácia) for SR seated IVD manufacturers/EC reps under § 110 ods. 2; EUDAMED actor/device modules become mandatory 28 May 2026 but the national notification duty is retained in reduced form. · verifiedHighlights: Class I devices (MD) and class A IVDs from foreign manufacturers need not be notified (voluntary).; National § 110b notification duty persists alongside EUDAMED from 28.5.2026.

A device from a foreign manufacturer may be supplied and sold in Slovakia while the notification/ŠÚKL code request is still being processed, provided EU and Slovak device legislation is met; the ŠÚKL code only needs to be awaited when it is required for Ministry of Health categorization (reimbursement listing), for which an urgent processing request is possible.

Under § 110b ods. 2 of zákon č. 362/2011 Z. z., the economic operator must notify ŠÚKL within 14 days of first making the device available on the Slovak market.

Manufacturers of medical devices (including active implantable devices) seated outside Slovakia — and their EC representatives, importers or distributors that make the device available on the Slovak market — must notify the device data to ŠÚKL under § 110b ods. 2 of zákon č. 362/2011 Z. z. Class I devices (MD) and class A IVDs from foreign manufacturers are exempt; notification of them is voluntary, mainly needed for Ministry of Health categorization (reimbursement).

Manufacturers of in vitro diagnostic devices and their EC representatives seated in Slovakia are subject to registration (registrácia) with ŠÚKL under § 110 ods. 2 of zákon č. 362/2011 Z. z. — for all their IVDs regardless of class, including class A. Filing fee 750 € (plus 430 € for the technical documentation assessment of each additional device).

Manufacturers of medical devices (including AIZP) and EC representatives seated in Slovakia notify/register all of their devices with ŠÚKL regardless of classification — including Class I devices — unlike the exemption that applies to foreign manufacturers' Class I devices.

Until the corresponding EUDAMED systems function, a manufacturer or authorised representative seated in Slovenia must submit to JAZMP a registration application for each non custom made device before placing it on the market; the application contains 16 items including trade name, GMDN/EU nomenclature code, risk class, basic UDI DI, and safety/performance summary for class C and D, plus a copy of the notified body certificate where applicable.

JAZMP issues the free sale certificate (certifikat o prosti prodaji) to manufacturers or authorised representatives seated in Slovenia within 30 days of receiving a complete application, on the basis of Art. 60 MDR and Art. 55 IVDR; application content is set by a JAZMP general act with the health minister's consent.

submissionSurface: EUDAMED shared layer plus JAZMP national registration and forms: manufacturers/importers/authorised representatives register via the EUDAMED Actors module routed through JAZMP (SRN issued by JAZMP); distributors and importers may file national registration via the SPOT e portal; devices of RS seated manufacturers/ARs were registered nationally under Art. 45 ZMedPri 1 until the corresponding EUDAMED modules function · verifiedHighlights: JAZMP publishes separate sections for actor registration, device registration, forms, vigilance, clinical investigation and free sale certificates.; The current national basis includes the Medical Devices Act ZMedPri 1 (UL RS 40/25); EUDAMED device registration transition ends 28 November 2026.

Manufacturers, distributors and wholesalers of non sterile, non measuring Class A medical devices are exempt from the establishment licensing requirement, per SAHPRA position statement 9.106; however the ISO 13485 requirement still applies even where the establishment is exempted from licensing.

Before commencing business, a manufacturer, wholesaler or distributor of medical devices/IVDs must apply for: (aa) a manufacturer licence to manufacture, import or export; (bb) a distributor licence to import, export and distribute; or (cc) a wholesale licence to act as wholesaler, and must appoint an authorised representative residing in South Africa.

For licence applications listing COVID 19, HIV and Mpox IVDs, applicants must provide evidence of premarket registration from one of the six jurisdictions recognised by SAHPRA, plus the OEM's ISO 13485 certificate and a technical dossier.

The registration process for medical devices is still in development; a Registration Call Up Plan will be published setting out the phased approach in which devices will be called up by type and class. Under Regulation 11(2), devices (except custom made) must be registered in terms of call up notices before being sold or used, and unregistered devices lawfully sold at commencement remain legal until their call up period expires (reg 28(1)).

Per item approval (허가) targets Class 3 and 4 devices, plus listed Class 1 2 exceptions: devices combined with drugs/quasi drugs, u healthcare devices, continuously worn respiratory monitors, devices not substantially equivalent or requiring clinical trial data, devices without notified sub classification, and new medical technology integrated review devices.

Importers must obtain import approval (수입허가) or import certification (수입인증), or file import notification (수입신고), for each device they import.

Manufacturers obtain product level manufacturing approval (제조허가), manufacturing certification (제조인증) or file manufacturing notification (제조신고). Devices with very low potential harm notified by MFDS are handled per product family (품목류별); all other devices per individual item (품목별).

Market entry follows the class route: Class 1 notification, Class 2 certification, Class 3 4 approval, plus KGMP conformity certification (적합성인정) for the manufacturer/importer as a prerequisite; Class 1 low risk items may be notified per product family.

Custom made device manufacturers established in Spain must be entered in the AEMPS Registro de Responsables (communication listing products manufactured and, for class III implantable custom made devices, the notified body certificate of conformity); the obligation extends to authorised representatives established in Spain, and communication through RPS remains mandatory for custom made manufacturers after RECOPS go live.

submissionSurface: CE marking under MDR/IVDR plus national RECOPS commercialization registration (AEMPS) from 15 June 2026 · verifiedHighlights: RD 192/2023 art. 18 and RD 942/2025 art. 15 oblige any economic operator commercializing devices (other than custom made) in Spain to be entered in the Registro de comercialización before commercialization.; From 28 May 2026 no new communications are accepted through the former CCPS and RPS registers, except custom made manufacturers, whose RPS obligation continues.; RECOPS requires the product to be notified and visible in EUDAMED; product data are downloaded from EUDAMED.

Economic operators commercializing products in Spain must make the communication to RECOPS within no more than six months from the product's notification to EUDAMED; the product must be notified and visible in EUDAMED because RECOPS downloads product data from EUDAMED.

Two consolidated dossier types exist for product registration: (1) FMSA + Product Registration Dossier (PRD) for general medical devices and IVDs, and (2) PRD without FMSA for general medical devices, IVDs and listed devices (foreign and local manufacturers). A consolidated dossier combines manufacturing site registration, sample import licence application and product registration in a single file. Listed medical devices are exempt from foreign manufacturing site registration.

Listed devices, Class I general medical devices and Class A IVDs that are non active, non sterile and without measuring function (Appendix 1 list) follow a simplified registration route under GL 037: they are exempt from manufacturing site registration (foreign sites), GMP inspection (local sites) and end user performance evaluation; dossiers are numbered D/Serial Number/LR.

route: Register device with NMRA (consolidated dossier) via local agent; then Licensing Division issues Registration Certificate and Import Licence · submissionSurface: Online Google form pre submission, then physical consolidated dossier (two copies of checklist) at the Dossier Accepting Point, 2nd Floor NMRA, Tuesdays 9:00 a.m.–3:00 p.m. · foreignManufacturerRoute: Mandatory Sri Lankan Marketing Authorization Holder (local agent) · lowRiskRoute: Simplified route for listed devices, non sterile/non active/non measuring Class I and Class A IVDs (GL 037) · relianceRoute: Reliance Pathway for products registered with a Reference NRA (web notice eff. 29.10.2025)

From 29 October 2025 NMRA considers eligible new device applications under a Reliance Pathway, relying on assessment and approval decisions of recognized Reference NRAs when sufficient regulatory evidence is available. Eligible if: (1) product registered with the NRA of the country of manufacture, (2) registered with the NRA of the legal manufacturer's country, or (3) product registered with any NMRA Reference NRA. End user evaluation is waived and evaluation is shorter; all other procedures, requirements and fees remain unchanged.

National registration obligations migrate to the European database Eudamed as its modules become subject to the functionality notice (old national registration rules applied until six months after the notice per the transitional provisions of förordning (2021:631)); the Swedish annual fee continues to be charged also when registration takes place in Eudamed.

No national pre market approval: devices placed on the Swedish market must meet MDR or IVDR and be CE marked; neither national registration nor Eudamed registration means any competent authority has reviewed or approved the device. National registration with Läkemedelsverket applies only to specified categories: manufacturers of custom made devices established in Sweden, manufacturers of national medical information systems (NMI) provided in Sweden, and importers/distributors assuming translation/re labelling or repackaging obligations under MDR/IVDR Art. 16.2 16.4 selling on the Swedish market; manufacturers, authorised representatives and importers of CE marked products register in Eudamed instead.

Manufacturers and their authorised representatives and importers must register their data (per Annex VI Part A Section 1 EU MDR) with Swissmedic within three months after first placing a product on the market; changes must be reported within one week; Swissmedic verifies the data and assigns a one time Swiss registration number (CHRN).

Registration of devices, systems and procedure packs (Art. 108 MedDO) in swissdamed becomes mandatory on 1 July 2026 and replaces the previous notification obligation; a transition period runs until 31 December 2026; there is no transition period for devices subject to reporting obligations for serious incidents, field safety corrective actions or trends.

Switzerland operates no national authorisation procedure for ordinary medical devices: market access rests on conformity assessment and certification following the EU system, with the CE mark recognised unilaterally in Switzerland, plus Swiss economic operator obligations (CH REP, registration, languages, vigilance); Swissmedic designates and monitors Swiss conformity assessment bodies.

Class I filing (登錄) is done in the central authority's online medical device filing system: the applicant enters product name, firm and manufacturer data, classification item code, sterilisation status, QMS conformity status, uploads the documents listed in Annex 5 ('documents to be uploaded for filing of Class I medical devices for manufacture or import'), pays the fee, and receives a filing number (登錄字號).

Manufacture or import of a medical device requires registration (查驗登記) with the central authority and a medical device licence (醫療器材許可證); however, item categories announced by the central authority are marketed via the simpler filing (登錄) route instead. Devices subject to registration may not use the filing route.

Applicants may request priority review (檢具佐證文件提出優先審查) for devices that: (1) prevent, diagnose or treat life threatening or seriously disabling disease with no suitable domestic drug, device or alternative therapy; (2) relate to rare diseases; or (3) are prioritised by government policy for R&D support and are or will be verified by domestic clinical trials, or meet urgent domestic public health needs.

Each application must contain exactly one of: a single medical device, one medical device family, one medical device system, or one medical device group; family members must share product owner, risk classification, intended purpose, design and manufacturing process, with variations within permissible variants.

Registration is the main route and applies to all class B, C and D medical devices and IVDs plus class A devices that are active, have a measuring function, or are sterile; notification is reserved for other class A devices and IVDs that do not meet the registration criteria.

Route depends on the risk based group of the device: licence route (ขออนุญาต, ใบอนุญาต), detailed notification route (แจ้งรายการละเอียด, ใบรับแจ้งรายการละเอียด), or notification route (จดแจ้ง, ใบรับจดแจ้ง); applied for by the registered manufacturer or importer.

Thai FDA accepts three submission tracks: Full evaluation (CSDT dossier), Abridged (device already registered for at least 1 year by a Big 5 reference agency), and Reliance (Singapore HSA registration with registrant consent).

There is not yet a standalone Tunisian medical device registration. Market access runs through the Autorisation de Mise à la Consommation (AMC) issued inside the contrôle technique à l'importation (CTI), and ANMPS states its own purpose as reducing the time needed to obtain the AMC 'with a view to a transition towards a registration'. The AMC is tied to the importation: the importer signs an 'Engagement pour CTI' undertaking that is unique to each importation. ANMPS's device 'Enregistrement des dispositifs médicaux' service page carries no published procedure, no fee ('NA'), no average timeline ('NA') and an empty required documents list, which is consistent with a registration regime not yet in operation.

ANMPS operates three AMC tracks. Products that obtained an AMC after 'avis' during the previous two years, and products that obtained one after 'analyse' during the previous two years, may obtain a systematic 'administrative' AMC. The administrative AMC requires: a technical dossier compliant with the requirements on file; payment of the AMC fees to ANMPS at the existing 'avis technique' or 'analyse' tariff although ANMPS performs neither service; the 'Engagement pour CTI' form signed once per importation; the AMCs obtained during the previous two years attached; and a copy of the labelling mock up or any other document identifying the articles by trade name. ANMPS issues the administrative AMC only on presentation of the payment receipt and of the undertaking signed by the manager of the importing company.

Before placing a device on the market, manufacturers apply the conformity assessment procedures of Annexes IX to XI; class III devices undergo Annex IX assessment (or Annex XI part A plus Annex X technical documentation per device), custom made and investigational devices excluded.

For export purposes, on request of a manufacturer or authorised representative established in Turkey, the Kurum issues a serbest satış sertifikası stating the registered workplace and that the CE marked device may be marketed in Turkey and EU member states; the Basic UDI DI is stated on the certificate.

Market access = EU style conformity assessment with CE marking under the Regulation, plus national registration duties in the ÜTS (Ürün Takip Sistemi) imposed on manufacturers, authorised representatives, importers, distributors, notified bodies, health institutions and other persons.

Registration is mandatory before sale or distribution, and an application is made before manufacture, importation or exportation (reg. 25(1), reg. 27(1)). NDA operates three registration tracks, defined in DAR/GDL/028 s. 4.12 and restated on NDA's Medical Devices page: Track 1 for products licensed in an IMDRF founding member country (Australia, Canada, European Union, Japan, United States); Track 2 for products not licensed in an IMDRF country but holding documented conformity to a quality system standard from a certification body accredited by an IMDRF regulatory authority, or WHO Prequalification, or another international organisation recognised by NDA; Track 3 for products with no certification to any of the accepted quality system standards, which must instead carry a Manufacturer's Declaration of Conformity to the IMDRF Essential Principles of Safety and Performance and pre clinical design verification and validation information. The application is made on Form 7 (Schedule 6 to S.I. 2014 No. 29; Appendix I to DAR/GDL/028). All applications and supporting documents must be typed in English, and where original copies are in another language they must be presented with a certified English translation (s. 4.2).

Conformity assessment for TR 753 is performed by 15 designated bodies listed by Держлікслужба (e.g. ДП «Укрметртестстандарт» UA.TR.001, ДП «Харківстандартметрологія» UA.TR.002, ТОВ «УКРМЕДСЕРТ» UA.TR.099), appointed by orders of the Ministry of Economic Development and Trade / Ministry of Economy; applicants may choose any designated body.

Class III: design examination (Annex 3) or type examination (Annex 4) combined with production quality assurance (Annex 5) or product verification (Annex 6); class IIa/IIb: Annex 3/4 with Annex 5, 6 or 7 (with class specific limitations on design verification); class I (non sterile, non measuring): internal production control (Annex 8) with self declaration, no designated body; custom made devices: Annex 9 procedure with a statement.

General IVDs (not in Annex 2 lists, not self testing): internal production control with manufacturer's declaration (Annex 3); List A: Annex 4 or Annex 5+7; List B: Annex 4 or Annex 5 combined with Annex 6 or 7; performance evaluation devices: manufacturer's statement per Annex 8; self testing devices additionally require designated body design verification.

Ukraine has no state product registration for devices: placing on the market requires conformity assessment under the technical regulation (manufacturer's declaration of conformity, with a designated body certificate where the class requires it) plus notification of the responsible person to the DLS electronic Register; the mark of conformity is affixed by the manufacturer.

EDE may grant conditional marketing approval for the categories listed in Article 8, including products for life threatening or serious diseases with significant therapeutic benefit and no available authorised equivalent, and unavailable products without an equivalent alternative. The conditions and controls in Article 9 must also be met; eligibility does not confer automatic approval.

A licensed local pharmaceutical establishment (medical warehouse or marketing office designated by the Marketing Rights holder) submits the device marketing authorization to EDE; the MAH company and product manufacturing sites must be registered with EDE beforehand.

Marketing Authorization Holder companies and product manufacturing sites must be registered with EDE before their products can be registered.

Class IIa devices follow a manufacturer declaration of conformity combined with an approved body route (product conformity verification, production quality assurance audit, final inspection and testing audit, or full quality assurance system). Class IIb follows a full quality assurance audit (Part II Annex II) or type examination (Annex III) plus one of the Class IIa options; Class III follows a full quality assurance audit including a design dossier examination, or Annex III type examination plus product conformity verification. The UKCA mark may be affixed and the device placed on the market only after receiving the approved body certificate.

For Class I medical devices, the manufacturer self declares conformity against the UK MDR 2002 by drawing up a written statement (technical documentation and declaration per Annex VII); for sterile or measuring Class I devices, the manufacturer must additionally apply to a UK approved body to approve and certify the sterility or metrology aspects of manufacture.

Devices placed on the Great Britain market must bear a UKCA marking or a CE marking depending on the legislation under which the device is certified; UKCA third party assessment is performed by UK approved bodies, eligible CE marked devices are accepted during the current statutory transition periods, and all devices must be registered with MHRA before being placed on the GB market.

Before placing a general medical device on the Great Britain market, the manufacturer must inform the Secretary of State (MHRA) of the address of its registered GB place of business, provide a description of the device, and pay the relevant fee under regulation 53; an overseas manufacturer must first appoint a sole UK responsible person who gives written evidence of their authority to act and assumes registration duties. Registration is complete only once device details are provided and MHRA confirmation is received.

The De Novo classification request (FD&C 513(f)(2), 21 U.S.C. 360c(f)(2)) is the route for novel devices of low to moderate risk without a valid predicate; it may be submitted after a 510(k) Not Substantially Equivalent decision or directly to FDA; content follows 21 CFR 860.220 and acceptance review 860.230; a grant (21 CFR 860.260) establishes a new classification, while a declined request leaves the device in Class III.

Market access routes: (1) 510(k) exempt Class I/II devices need only establishment registration and listing; (2) 510(k) premarket notification under 21 CFR 807 subpart E for most Class II and some Class I devices; (3) De Novo classification request under FD&C 513(f)(2) / 21 CFR part 860 for novel low to moderate risk devices; (4) Class III PMA under 21 CFR part 814. Every route additionally requires establishment registration and listing under 21 CFR 807 subparts A and B.

A premarket notification must be submitted to FDA at least 90 days before the person introduces the device into commercial distribution; a new 510(k) is required for a change or modification that could significantly affect safety or effectiveness, or for a major change in intended use.

All products defined in Decreto 3/008 (diagnostic reagents, therapeutic devices, medical equipment) must be registered with the MSP; applications are submitted by companies holding a valid MSP habilitación, and registration is done by families of products.

submissionSurface: Registration and renewal applications are filed electronically through the VUCE PIRM trámite ('PIRM MSP Recepción de solicitudes de registro de productos de DETM'), backed by the MSP manual dossier ('carpeta', max 20 products per folder, all within the same family) and category specific forms. · verifiedHighlights: Separate registration forms per category: FO 13222 006 equipo médico, FO 13222 007 reactivo de diagnóstico, FO 13222 008 dispositivo terapéutico.; Certificate issued: 'Certificado de Registro y Autorización de venta de Productos Médicos'.

Devices undergo state registration either by the ordinary procedure (умумий тартиб) or by the recognition route (тан олиш йўли); recognition applies to devices already registered by specified foreign regulators.

Dedicated application forms exist for fast track (cấp nhanh, Mẫu 06) and urgent (cấp khẩn cấp, Mẫu 07) Class C/D circulation number applications under Circular 44/2025.

Class C/D devices may only circulate in Vietnam with a circulation number (số lưu hành) issued by the competent authority; Class A/B devices circulate after declaration of the applied standard (công bố tiêu chuẩn áp dụng), except where exemption applies.

statement: A person who intends to place a non in vitro medical device on the Zambian market must apply to ZAMRA for marketing authorisation. The application comprises a cover letter, a duly completed and signed application form (Annex 1), proof of payment of the prescribed application fee, at least two samples of the device in the smallest commercial pack size labelled primarily in English, a completed Annex 2 checklist, and the product dossier. Where a product has variants such as size, design, dimensions or capacity the variants are treated as different products and require separate applications. An incomplete application is not accepted if any of those six items is missing. The dossier is presented as an electronic text selectable/editable PDF submitted via the Authority's online portal, and for IVDs one hard copy and one soft copy are required.

statement: For the two regulated device classes the pathway has two steps. First, a person who wishes to obtain the Authority's approval of a type and brand of condom applies in duplicate on Form M.C.Con.1, and a person seeking approval of a type of glove applies in duplicate on Form M.C.G.1, each accompanied by the prescribed fee and the appropriate number of samples. Second, and separately, no importer, manufacturer or wholesaler may sell a condom or glove unless the batch of which it is part has been approved for distribution by the Authority; that batch application is made in duplicate on Form M.C.Con.2 or M.C.G.2. MCAZ's own description is that 'Male condoms and medical gloves types and brands are initially registered and granted market authorisation prior distribution' and that 'Routine compliance checks of subsequent shipments is also done for all the condom and glove batches imported into the country.' There is no registration pathway for any other medical device.