Explore the medical device requirements currently available for Switzerland, organized by topic and linked to official sources.
Which claims, audiences, channels, approvals, and restrictions apply?
Advertising of devices may contain exclusively statements consistent with the product information; misleading claims are prohibited; public advertising is prohibited for devices intended exclusively for use by healthcare professionals.
What expires, what is retained periodically, and when must renewal start?
Route Dependent
No Swiss product-licence expiry exists for ordinary CE-conforming devices (there is no national authorisation procedure); the time-limited instrument is the conformity assessment certificate issued by a designated body: maximum 5 years validity, extendable on application by up to 5 years per re-assessment, repeatedly (Art. 26 MedDO; identical rule for IVDs in Art. 22 IvDO); legacy devices continue under the Art. 100/101 MedDO and Art. 81/82 IvDO transition deadlines instead of a renewal mechanism.
Art. 26(3): a supplement to a certificate is valid as long as the certificate to which it belongs. IvDO Art. 22(1): 'Die Bescheinigungen sind maximal fünf Jahre gültig.'
Does the event require internal documentation, notice, prior approval, transfer, or a new application?
Changes to registered actor data must be reported to Swissmedic by the economic operator concerned within one week.
Registered actor data changes are notified within one week (Art. 55(2) MedDO); device data updates in swissdamed are free of charge (administrative update); changes affecting the device or mandate follow the EU change regime (Art. 12 EU-MDR via Art. 51(4) MedDO), with certificate supplements where required (Art. 26(3)); re-registration of a 'discarded' device in swissdamed is a new, fee-bearing registration.
Effective from 2026-07-01
Swissmedic fee page: 'Updates to existing data are free of charge.' and 'A fee is payable for the new registration of a device that was "discarded"'.
Effective from 2026-07-01
The original baseline claim that a legacy device becoming MDR-compliant requires a new swissdamed registration with a new Basic UDI-DI/UDI-DI could not be confirmed on the official pages opened; what is verified is the registration obligation covering legacy devices still on the market and the fee/re-registration rules above.
Which clinical or IVD performance evidence or study is required and accepted?
Demonstration of compliance with the general safety and performance requirements includes a clinical evaluation in accordance with Art. 61 EU-MDR (incorporated by reference into the MedDO).
Clinical investigations with medical devices are categorised under KlinV-Mep: category A (subcategories A1/A2) — CE-marked device used per its instructions for use and not banned in Switzerland; category C — CE-marked off-label use (C1), non-CE device (C2), banned device (C3). Category A investigations are exempt from the Swissmedic approval requirement under TPA Art. 54(1); for category C, the reports and notifications under Arts. 35-37 KlinV-Mep must also be submitted to Swissmedic.
Is the product a device, IVD, accessory, software, or borderline product locally?
An IVD is a medical device under Art. 3(1)-(2) MedDO that is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, device, software or system, intended by the manufacturer for in-vitro examination of specimens derived from the human body.
Medical devices are instruments, apparatus, equipment, software, implants, reagents, materials or other articles intended by the manufacturer for use in humans whose principal intended action in or on the human body is not achieved by pharmacological, immunological or metabolic means (the mechanism of action may be assisted by such means).
Which evidence, local deltas, formats, and signatures are required?
The CH-REP must keep a copy of the technical documentation available; alternatively, the manufacturer and CH-REP may agree contractually that the manufacturer delivers the documentation directly to Swissmedic on request, in which case the CH-REP must ensure delivery to Swissmedic within seven days.
Technical documentation must be compiled in accordance with Annexes II and III EU-MDR and kept available; records must be retained for at least 10 years after the last device covered by the declaration of conformity was placed on the market, and at least 15 years for implantable devices.
Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?
Manufacturer Mandated Authorized Representative
Swiss authorised representative (Bevollmächtigter, CH-REP)
Yes For Foreign Manufacturer
Art. 51(1) MedDO; Art. 44 IvDO
must be agreed in writing; the CH-REP is responsible for formal and safety-related matters vis-à-vis Swissmedic
registers as actor in swissdamed and covers the mandated devices
separate registered actor (Art. 4(1)(h) MedDO)
separate supply-chain role (Art. 4(1)(i) MedDO)
roles may be combined if each is fulfilled and registered
Art. 51(4) MedDO applies Art. 12 EU-MDR (changes) to the mandate; Art. 4(1)(g) MedDO defines 'Bevollmächtigter' as any person established in Switzerland mandated in writing by a foreign manufacturer.
Swissdamed Mandate Inactivation And New Mandate
mandates are recorded per device in swissdamed Actors (not yet mandatory, but Swissmedic can request publication via Art. 51(3) MedDO in conjunction with Art. 11(3) EU MDR)
an inactivated mandate cannot be reactivated; a new mandate must be created and devices relinked
a reactivation of the actor registration is possible after review by Swissmedic, subject to a fee, if revalidated within six months
No Generic Fresh Conformity Assessment
Reactivation fee charged on a time-and-material basis per Art. 4(2) FeeO-Swissmedic (SR 812.214.5).
Which establishment licences, importer permissions, and distribution controls apply?
Importers may only place compliant products on the market and must verify before doing so: presence of the conformity mark; availability of the declaration of conformity; that the manufacturer is known and has mandated a person per Art. 51; correct labelling and availability of instructions for use; and UDI assignment where required; they must state their own name and address on the product, packaging or accompanying document, and must withhold non-conforming products until conformity is established. Distributors verify the same items (except importer details) with due care, on a sampling basis except for the importer-information check, and must withhold non-conforming products.
No separate Swiss import licence exists; importers are registered actors under Art. 55 MedDO.
Which label and IFU elements, languages, symbols, and translation controls apply?
Product information (labelling and instructions for use) must be in the three official Swiss languages (German, French, Italian); symbols concretised by technical standards may replace language statements. The product information may be limited to fewer than three official languages or to English if the product is supplied exclusively to healthcare professionals, or is a custom-made device or a device manufactured in a health institution (Art. 9).
Which current law, regulation, guidance, and transition provisions apply?
The Ordinance on In Vitro Diagnostic Medical Devices (IvDO/IvDV, SR 812.219) of 4 May 2022 entered into force on 26 May 2022, except Art. 16(5) and Art. 90(2), which enter into force at a later time.
Effective from 2022-05-26
Switzerland is not an EU member; the IvDO (like the MedDO) incorporates EU-IVDR provisions by reference rather than applying EU law directly.
Implantable Class III custom-made devices (Sonderanfertigungen) may be placed on the market until 26 May 2026 without a certificate from a Swiss designated body or an EU/EEA notified body, provided a formal application for conformity assessment was filed by 26 May 2024 and a written agreement was signed by 26 September 2024.
Effective from 2023-11-01 · Effective until 2026-05-26
Continued placing on the market of legacy IVDs under Art. 82(1) IvDO requires: continued compliance with previous law; no significant design/intended-purpose changes; no unacceptable risk; a QMS per Art. 10(8) EU-IVDR established by 26 May 2025; staged formal applications to a designated or EU/EEA notified body (certificate and Class D self-declared devices by 26 May 2025; Class C by 26 May 2026; Class B and sterile Class A by 26 May 2027) and written agreements signed four months later in each case (26 September 2025/2026/2027).
Effective from 2025-01-01
Legacy IVDs may continue to be placed on the market until: products with a valid certificate under Art. 81 IvDO, 31 December 2027; self-declared old-law products whose IvDO assessment requires a designated body - Class D until 31 December 2027, Class C until 31 December 2028, Class B and sterile Class A until 31 December 2029.
Effective from 2025-01-01 · Effective until 2029-12-31
PMS, market surveillance, vigilance, actor and device registration under the IvDO apply to these products during the transition (Art. 82(2)); devices lawfully placed on the market may continue to be made available (Art. 82(3)).
Continued placing on the market of legacy medical devices under Art. 101(1) MedDO requires: continued compliance with the previous law; no significant changes in design or intended purpose; no unacceptable risk to patients, users or others; a QMS per Art. 10(9) EU-MDR established by 26 May 2024; a formal application to a Swiss designated body or an EU/EEA notified body filed by 26 May 2024; and a written agreement with that body signed by 26 September 2024.
Effective from 2023-11-01
Swiss designated bodies and EU/EEA notified bodies are treated equally for these applications.
Legacy medical devices may continue to be placed on the market until: (a) self-declared devices under the old law whose conformity assessment under MedDO requires a designated body, until 31 December 2028; (b) devices with valid old-law certificates - Class III and implantable Class IIb (except sutures, clips and listed dental products) until 31 December 2027, and other Class IIb, Class IIa, sterile Class I and Class I with measuring function until 31 December 2028.
Effective from 2023-11-01 · Effective until 2028-12-31
Art. 101(3): devices lawfully placed on the market before 26 May 2021 or under paras 1/1ter may continue to be made available; Art. 103 reserved.
The Medical Devices Ordinance (MedDO/MepV, SR 812.213) entered into force on 26 May 2021, except Art. 17(5) and Art. 108(2), which enter into force at a later time.
Effective from 2021-05-26
Because Art. 17(5) is not yet in force, the old MepV 2001 Art. 6 notification duties for Swiss-established persons continue to apply per Art. 108(1) MedDO.
Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?
Manufacturers of Class IIa, IIb and III devices must prepare a safety update report (Sicherheitsbericht, PSUR) for each product or product category/group: Class IIa updated as needed and at least every two years; Classes IIb and III at least once a year. For Class III and implantable devices the report and its amendments are reviewed by the designated body, and on request must be submitted to Swissmedic.
Swissmedic states that for IVDs PSURs apply to Classes C and D (to the designated body, to Swissmedic on request).
For every product, manufacturers must plan, establish, document, apply, maintain and keep up to date a post-market surveillance system proportionate to the risk class and the type of product; the system is an integral part of the manufacturer's quality management system, and its modalities (including updates of the technical documentation) follow Art. 83(3) EU-MDR.
Which current form, portal, account, and submission package must be used?
Actor and mandate registration is done in the swissdamed portal (legal basis TPA Art. 62c): access requires CH-LOGIN (Swiss federal government login), with Swiss companies verified against the Zefix commercial register; upon approval of the registration request, Swissmedic sends a confirmation e-mail containing the CHRN.
TPA Art. 62c: 'Das Institut führt zur Erfüllung seiner Aufgaben ein Informationssystem Medizinprodukte'; data may be automatically matched with Eudamed (Art. 62c(3)).
Which QMS, audit, inspection, and certificate scope is accepted or required?
Manufacturers' further obligations, in particular the requirements for the quality management system and the risk management system, follow Art. 10 EU-MDR as incorporated by reference into the MedDO (for IVDs, Art. 10 EU-IVDR via the IvDO).
Which recall, FSCA, notice, and authority-coordination duties apply?
If a manufacturer or SPPP conducts a field safety corrective action involving devices available on the Swiss or Liechtenstein market, it must notify Swissmedic of the FSCA without delay. Field safety notices (FSN) directed at users or customers must be published on the Swissmedic website (www.swissmedic.ch/md-fsca-en), one machine-readable PDF per language, with personal data redacted, under TPA Art. 67, MedDO Art. 90(g) and IvDO Art. 73(g).
MedDO Art. 90(g): Swissmedic publishes 'die im Rahmen von Sicherheitskorrekturmassnahmen im Feld ... gerichteten Sicherheitsanweisungen im Feld nach Artikel 89 Absatz 8 EU-MDR'.
Which registration, notification, listing, reliance, or conformity route applies?
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).
Further modalities follow Art. 30(3) and 31 EU-MDR by reference (Art. 55(3)).
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.
Effective from 2026-07-01
Until then, the notification regime under old Art. 6 MepV 2001 continues via Art. 108 MedDO; notifications for repackaging/relabeling (Art. 53/54 old law), health-institution manufacture (Art. 18) and custom-made devices (Art. 19) remain outside the registration regime.
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.
Swissmedic page (EN); EU MDR/IVDR provisions apply via incorporation by reference in MedDO/IvDO, not as directly applicable EU law.
Which foreign decisions or evidence can be reused, with what effect and conditions?
Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.
Prior approval / evidence record
Armenia registers medical devices under two national procedures: a general procedure and a simplified procedure. The simplified procedure applies to a device that is registered in a country that is a member of the International Medical Device Regulators Forum (IMDRF) or that is prequalified by the World Health Organization. IMDRF members include the United States (FDA), the EU member states (CE marking), Japan (PMDA), Korea (MFDS), China (NMPA), Canada, Australia, Brazil, Singapore and the United Kingdom, so a US FDA 510(k)/PMA clearance, an EU CE mark, a Japan PMDA approval and a Korea MFDS approval all satisfy the gate. The device is still registered in Armenia by the Armenian authority — the foreign registration opens the shortened procedure, it does not replace the Armenian certificate.
Registration in any IMDRF member country — US FDA 510(k)/PMA, EU CE marking under MDR/IVDR (any EU member state), Japan PMDA, Korea MFDS, China NMPA, Health Canada, Australia TGA, Brazil ANVISA, Singapore HSA, UK MHRA — or WHO prequalification of the device
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Language: Armenian. Verbatim, Article 46(4): "Սույն հոդվածի 3-րդ մասով սահմանված կարգի համաձայն՝ բժշկական արտադրատեսակները գրանցվում են ընդհանուր և պարզեցված ընթացակարգերով: Պարզեցված ընթացակարգը կիրառվում է բժշկական արտադրատեսակների շրջանառությունը կարգավորող մարմինների միջազգային համաժողովի (IMDRF) անդամ երկրում գրանցված կամ Առողջապահության համաշխարհային կազմակերպության նախաորակավորած բժշկական արտադրատեսակների համար:" Translation: "Under the procedure laid down by part 3 of this article, medical devices are registered under general and simplified procedures. The simplified procedure applies to medical devices registered in a member country of the International Medical Device Regulators Forum (IMDRF) or prequalified by the World Health Organization." Article 46 was amended by the Law of 5 December 2024 ՀՕ-502-Ն; the consolidated expression is the version in force from 31.05.2026.
Prior approval / evidence record
Registration certificate from SFDA (Saudi Arabia), US FDA, TGA (Australia), PMDA (Japan), MHRA (United Kingdom), HPRA (Ireland), Swissmedic (Switzerland), ANSM (France) or BfArM (Germany)
Yes
Article (7) bis of Resolution No. (48) of 2020, inserted by Resolution No. (69) of 2024, provides by way of exception to the ordinary Article (7) prohibition that medical devices and products registered in one of the nine listed reference countries 'shall also be registered in the Kingdom of Bahrain' on the basis of that country's registration certificate, on payment of the applicable fee. This is a documentary registration route rather than a full de novo technical assessment, but the application is still filed by a licensed Bahraini Authorized Representative and NHRA retains the decision.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
Article (7) bis of Resolution No. (48) of 2020, inserted by Resolution No. (69) of 2024, provides that by way of exception to the ordinary Article (7) prohibition, medical devices and products registered in one of nine listed reference countries 'shall also be registered in the Kingdom of Bahrain' on the basis of the registration certificate issued by that country, following payment of the applicable fee. The listed reference authorities are SFDA (Saudi Arabia), FDA (United States), TGA (Australia), PMDA (Japan), MHRA (United Kingdom), HPRA (Ireland), Swissmedic (Switzerland), ANSM (France) and BfArM (Germany). A holder of a US FDA or Japan PMDA registration therefore has a documentary registration route in Bahrain rather than a full de novo technical assessment.
US FDA registration/clearance; Japan PMDA approval; Saudi SFDA registration; Australia TGA registration; UK MHRA registration; Ireland HPRA registration; Swissmedic (Switzerland) registration; France ANSM registration; Germany BfArM registration
Abridged Or Recognition Route
facilitated
Product Marketing
Yes
Yes
Effective from 2024-11-22
Verbatim source passage: "By way of exception to Article (7) of this Resolution, medical devices and products registered in one of the following reference countries shall also be registered in the Kingdom of Bahrain: 1. Kingdom of Saudi Arabia - Represented by the Saudi Food and Drug Authority (SFDA). 2. United States of America - Represented by the Food and Drug Administration (FDA). 3. Australia - Represented by the Therapeutic Goods Administration (TGA). 4. Japan - Represented by the Pharmaceuticals and Medical Devices Agency (PMDA). 5. United Kingdom - Represented by the Medicines and Healthcare products Regulatory Agency (MHRA). 6. Ireland - Represented by the Health Products Regulatory Authority (HPRA). 7. Switzerland - Represented by Swissmedic(Swissmedic). 8. France - Represented by the French National Agency for Medicines and Health Products Safety (ANSM). 9. Germany - Represented by the Federal Institute for Drugs and Medical Devices (BfArM). Based on the registration certificate issued by one of these countries, following the payment of the applicable fee."
Prior approval / evidence record
At renewal, Bahrain requires a Free Sale Certificate (FSC) or Certificate to Foreign Government issued by the regulatory authority of the country of origin or of a reference country (Registration Guideline 9.1, section 10 item 4). The guideline's glossary (item 14) defines reference countries as Saudi Arabia, USA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, New Zealand, France, Holland and Belgium, so a certificate from one of those authorities substitutes for an origin-country free-sale certificate. A Free Sale Certificate is also required on manufacturer acquisition (section 12).
Free Sale Certificate or Certificate to Foreign Government from the country of origin or from a reference country (Saudi Arabia, USA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, New Zealand, France, Holland, Belgium)
Origin Country Evidence
Evidence Only
Premarket Review
Yes
Yes
Verbatim source passages: "Free Sale Certificate (FSC) or Certificate to foreign government issued by the regulatory authority of the country of origin or a reference country." and "Reference countries: Saudi Arabia, USA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, New Zealand, France, Holland, Belgium."
Prior approval / evidence record
To obtain an NHRA classification letter, the applicant must supply a Free Sale Certificate or Registration Certificate issued by the competent authority of the country of origin or by one of the reference countries listed in the classification guideline (SFDA, USA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, New Zealand, France, Holland, Belgium), together with a recognised quality assurance certificate such as ISO 13485, CE mark or FDA.
Registration certificate or Free Sale Certificate from SFDA (Saudi Arabia), US FDA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, New Zealand, France, Holland or Belgium
Origin Country Evidence
Evidence Only
classification
Yes
Yes
Verbatim source passage: "1. Free Sale Certificate OR Registration Certificate issued from competent authority in country of origin classifies the product as a medical device. 2. Free Sale Certificate OR Registration Certificate issued from one of the following reference countries: (SFDA, USA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, Newzland, France, and Holland, Belgium.)."
Prior approval / evidence record
The Medicines and Related Substances Act, 2025 introduces reliance on decisions by trusted authorities and mutual recognition agreements, and the draft Medical Devices Regulations, 2026 would let BoMRA rely on approvals from IMDRF member authorities, African Medical Devices Forum recognised authorities, WHO prequalification, WHO Listed Authorities and Maturity Level 3/4 authorities, and on MDSAP audit outcomes. Neither instrument is in force: the Act's commencement is 'ON NOTICE' and the Regulations are unpublished drafts. A holder of a foreign approval therefore has no route under these provisions today.
none
No Reliance Route
none
Premarket Review
Yes
Yes
Status is official-source-verified for the text of the draft; the conditions and the reliance-recognition value record that the instrument is not in force. This is the deliberate 'do not upgrade a policy aspiration into an operating route' fact for Botswana. The draft would also give registration a five-year term (draft reg. 20(1)).
Prior approval / evidence record
Stringent Regulatory Authority approval — ICH members (European Commission, US FDA, Japan MHLW/PMDA), ICH observers (Swissmedic, Health Canada) or an authority associated with an ICH member through a legally binding mutual recognition agreement (including Australia, Iceland, Liechtenstein and Norway)
No
The SRA definition in G01 s.3.1.26 is used for dossier and reference purposes rather than as an automatic grant: an SRA approval does not by itself confer a Botswana registration, and it benefits the applicant only through the abridged pathway's proof-of-reference-agency requirement, which is defined by the separate Reference Regulatory Authority concept.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
For a Class B, C or D general medical device, an existing approval from a Stringent Regulatory Authority, a BoMRA-recognised Reference Regulatory Authority, or WHO prequalification, together with a valid ISO 13485 certificate, qualifies the application for the abridged assessment pathway instead of full evaluation. Class B accepts one approval from an RRA, an SRA or WHO. Class C requires at least one SRA or WHO approval, plus at least three years on the market in an SRA jurisdiction and no safety issues in the previous three years. Class D requires approvals from at least two RRAs including one SRA, plus the same three-year marketing and safety conditions. The local application and the final BoMRA decision are retained in all cases.
Any Stringent Regulatory Authority (ICH member: European Commission, US FDA, Japan MHLW/PMDA; ICH observers: EFTA/Swissmedic, Health Canada; ICH-associated via MRA: Australia, Iceland, Liechtenstein, Norway) or a BoMRA-recognised Reference Regulatory Authority, or WHO (with valid ISO 13485 certification or equivalent)
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Effective from 2024-12-09
SRA is defined in the same guideline at s. 3.1.26 as an ICH member (European Commission, US FDA, MHLW/PMDA), an ICH observer (EFTA as represented by Swissmedic, and Health Canada), or an authority associated with an ICH member through a legally binding mutual recognition agreement (Australia, Iceland, Liechtenstein, Norway). China NMPA is NOT an SRA on that definition. RRA is defined at s. 3.1.25 by cross-reference to BoMRA policy 'Recognition and-or Reliance on Information on Medical Devices including IVDs from Regional and International Regulatory Agencies BOMRA-ER-MED-Policy No.1', which was not found published on the BoMRA site.
Regulatory reference
Health Canada maintains a List of Regulatory Agencies (around 40 authorities including US FDA, ANVISA, TGA, MHRA, PMDA/MHLW, COFEPRIS, MFDS, HSA, Swissmedic and NMPA) incorporated by reference into MDR ss.61.2 and 68.3; decisions of these agencies trigger Canada's 72-hour foreign risk notification duty.
Page issued 2024-01-03, modified 2024-01-24.
Regulatory reference
Per Article 47 of the Reglamento (acápite 3.2.4), devices with prior registration in their country of origin or in another country with a device regulatory program based on the same essential safety/efficacy requirements as the Cuban program (such as IMDRF members) are exempt from presenting: software validation report, biological pre-clinical evidence, safety/environmental/parametric test reports, raw-material certificates of analysis, and stability study. In lieu they present the Certificate of Registration of the origin country or an internationally recognized regulatory program; where the device circulates under manufacturer responsibility without registration, a manufacturer declaration plus evidence of circulation suffices.
Effective from 2016-07-29
Reinforced by E 132-25 epígrafe 3.8: the CECMED will, as appropriate, take into account decisions of other regulatory authorities and regional/international bodies.
Regulatory reference
From 28 January 2027, the simplified procedure requires registration from an authority that satisfies BOTH high-vigilance status and IMDRF membership (Article 31). Article 32 additionally requires device marketing in an IMDRF Management Committee country, device-scope authorisation and ARCSA risk classification I-IV. IMDRF membership alone is not sufficient, and NMPA eligibility is not established by this general rule.
Effective from 2027-01-28
Recognition opens a simplified procedure; it is not a full reliance approval.
Regulatory reference
For imported devices, a Certificate of Free Sale (CLV) or equivalent is accepted from the country of manufacture or export, from a high-vigilance agency, or from an IMDRF member country; if the CLV or the product-owner authorization states no validity date, ARCSA considers it valid for a maximum of two years from issuance. Electronic CLVs are accepted without apostille when verifiable on the issuing authority's website.
Effective from 2027-01-28
Current regime already requires a CLV/Certificate of Exportation for imports (2016 Art. 16.a).
Regulatory reference
EDA recognizes reference countries: EU member states plus Australia, Canada, Iceland, Ireland, Japan, New Zealand, Norway, Switzerland, United Kingdom and United States of America; devices from these countries get reduced documentation, while devices from non-reference countries need extra evidence.
Variation guideline v03 (res-eg-variations) lists the same set plus Croatia and Liechtenstein.
Regulatory reference
A device registered, or approved for marketing and actually marketed, in a 'recognized state' (מדינה מוכרת) is registered in the Israeli register for a period not exceeding the period it may be marketed in that state, capped at 5 years from Israeli registration. Recognized states are listed in the First Addendum to the law — 21 states including the US, UK, Germany, France, Italy, Spain, the Netherlands, Belgium, Ireland, Denmark, Sweden, Finland, Norway, Iceland, Greece, Portugal, Austria, Switzerland, Australia, Canada and New Zealand (no single 'EU' entry: member states are listed individually).
First Addendum list per the official Sefer HaChukim text of the law held from gov.il.
Regulatory reference
PPB's Guidelines on Reliance Mechanisms for Marketing Authorization apply to all health products and technologies including medical devices: PPB may base part or all of its regulatory decisions on prior evaluations conducted by trusted reference authorities while retaining authority for final approval. Eligible reference mechanisms listed include WHO Prequalification Programme / Collaborative Registration Procedure, Stringent Regulatory Authorities (US FDA, EMA, Health Canada, Swissmedic, PMDA Japan, TGA Australia) and the East African Community Medicines Regulatory Harmonization (EAC-MRH).
Regulatory reference
The medical device registration guideline recognizes marketing clearances from eight listed reference regulatory agencies: Australia TGA, Health Canada, EU Notified Bodies (MDD/AIMDD/IVD Directive certificates), Japan MHLW, US FDA (510(k) or PMA), Ireland HPRA, Saudi Arabia SFDA and Swissmedic. US FDA 510(k)-exempt products do not qualify for the abridged route. Approvals from EU and TGA count as independent reference approvals only if the devices were reviewed and approved by those agencies themselves and not registered on the basis of a Mutual Recognition Agreement (MRA).
Prior approval / evidence record
A registration application must be accompanied by at least one of a closed menu of conformity documents: the US FDA approval (510(k) or PMA) or an FDA certificate for foreign governments; a CE marking certificate issued by a notified body plus the manufacturer's declaration of conformity; a safety certificate issued by a competent authority of Australia, Canada or Japan or other IMDRF countries; a certificate of conformity to Lebanese standards issued by the Industrial Research Institute; or — for products originating outside the EU, USA, Canada, Australia and Japan — an ISO 13485 quality-system certificate. A manufacturer's authorisation for the local distributor is required in all cases.
US FDA 510(k)/PMA and FDA certificate for foreign governments; EU CE marking certificate plus declaration of conformity; safety certificates of Australia TGA, Health Canada, Japan and other IMDRF member authorities; Lebanese IRI certificate
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Effective from 2013-11-01
Source language French. The excerpt is the contiguous run at the head of the list; the list continues on the next page, past a running header, with the CE and IMDRF bullets, quoted here separately: "o Certificat de marquage CE délivré par un organisme notifié (nom et numéro de l'organisme notifié doivent figurer d'une façon claire) ainsi que la déclaration de conformité faite par le fabricant. o Certificat garantissant la sécurité du dispositif délivré par l'une des autorités compétentes des pays suivants: Australie, Canada ou Japon et autres pays de l'IMDRF. o Certificat de conformité aux normes libanaises délivré par l'institut de recherche industriel (IRI) le cas échéant." Translation of the excerpt: "The registration application must be accompanied by at least one of the following documents: the approval of the US FDA administration (510(k) or PMA certificate); a US FDA certificate for foreign governments." Translation of the continuation: "a CE marking certificate issued by a notified body (notified body name and number must appear clearly) together with the declaration of conformity made by the manufacturer; a certificate guaranteeing the safety of the device issued by one of the competent authorities of the following countries: Australia, Canada or Japan and other IMDRF countries; a certificate of conformity to Lebanese standards issued by the industrial research institute (IRI), where applicable."
Prior approval / evidence record
GHTF/IMDRF member countries — free-sale certificate (شهادة بيع حر)
Yes
A mandatory document rather than a route: Decision 1506/1 Art. Four requires the registration application to carry a free-sale certificate issued by a country belonging to the GHTF/IMDRF group, meaning the device is sold in one of those countries whatever its origin, and the Ministry's service records require a free-sale certificate with an ISO 13485 certificate where the goods are made outside the reference states or the listed documents cannot be produced. No examination period is shortened by it.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
In addition to the documents required by Article Six of Decision No. 455/1 of 16 April 2013, a registration application must be accompanied by a free sale certificate or a certificate for foreign government issued by one of the countries belonging to the IMDRF (International Medical Devices Regulators Forum) — that is, proof that the device is sold in one of those countries, whatever its origin. This is a separate and mandatory documentary condition, not a route to a shortened review. (Decision No. 1506/1 of 1 September 2014, Article Four.)
Free sale certificate or certificate for foreign government issued by an IMDRF member country (the decision names the IMDRF group rather than individual authorities)
Origin Country Evidence
Evidence Only
Premarket Review
Yes
Yes
Effective from 2014-02-18
Source language Arabic; the PDF is a scan with no text layer and the text was recovered by OCR (pdftoppm -r 300 -png + tesseract -l ara+eng), so the wording is an OCR reading and Arabic-Indic digits are unreliable — hence source-backed-partial. OCR original: "إضافة الى المستندات المطلوبة في المادة السادسة من القرار رقم 1/455 تاريخ 2013/4/16، يرفق بطلب التسجيل شهادة بيع حر Free sale certificate أو certificate for foreign government صادرة عن احدى الدول المنتمية الى مجموعة IMDRF (International Medical Devices Regulators Forum) اي انها تباع في واحدة من هذه الدول مهما كان منشؤها." Translation: "In addition to the documents required under Article Six of Decision No. 455/1 of 16/4/2013, the registration application shall be accompanied by a free sale certificate or a certificate for foreign government issued by one of the countries belonging to the IMDRF (International Medical Devices Regulators Forum); that is, that it is sold in one of these countries, whatever its origin." The article number (المادة الرابعة, Article Four) is legible in the OCR.
Prior approval / evidence record
US FDA (510(k)/PMA approval or approval letter), European Union (conformity certificate issued by the manufacturer and by EU-notified bodies), Swiss, Australian, Canadian or Japanese competent health authorities (conformity certificate)
Yes
Accepted and in practice required for an implantable device: Decision 455/1 Art. Six lists them as the conformity documents that go into the registration file — a European-standards certificate from the manufacturer and EU-notified bodies, an FDA marketing approval or approval letter, or a conformity certificate from the health authorities of Switzerland, Australia, Canada or Japan — and Decision 1506/1 Art. Four requires a GHTF/IMDRF free-sale certificate on top. The Ministry's service records for sterile instruments and laboratory reagents require FDA evidence for US-origin goods and CE evidence for European ones. The benefit is documentary, not a shortened clock: none of the instruments publishes an abbreviated examination period, and the registration certificate is still issued on the Health Technology Unit's advice to the Minister.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Regulatory reference
Exceptional authorisations (Ausnahmebewilligungen) for non-compliant devices issued by Swissmedic under the Swiss-side rules (Art. 22 Abs. 1 MepV, Art. 18 Abs. 1/61 Abs. 3 IvDV) are valid for the whole customs territory (Switzerland/Liechtenstein); Liechtenstein accepts Swissmedic acts for the customs-union channel.
Effective from 2024-02-27
Prior approval / evidence record
Vía regulatoria abreviada — ARR equivalence (COFEPRIS-04-050)
The single reliance route since the DOF Acuerdo of 18 July 2025, which took effect 30 working days after publication and abrogated every individual equivalence agreement issued between 2012 and June 2025 — the separate FDA, Swissmedic, European Commission, Health Canada, TGA and WHO prequalification acuerdos no longer exist. COFEPRIS now recognises the decision of any Reference Regulatory Authority from a country sitting on the IMDRF Management Committee, and MDSAP full membership for GMP certificates. The dossier drops to an administrative-legal section plus technical information under RIS Art. 31.
Resolution within a maximum of 30 working days
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
class-ii
Class II
medium
Registration or Equivalency
35
35
days
official-verified
RIS Art. 179 — statutory resolution periods by class (COFEPRIS)
https://salud.gob.mx/unidades/cdi/nom/compi/ris.html
2026-08-25
15
31
months
8
16
months
No
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
class-iii
Class III
highest
Registration or Equivalency
60
60
days
official-verified
RIS Art. 179 — statutory resolution periods by class (COFEPRIS)
https://salud.gob.mx/unidades/cdi/nom/compi/ris.html
2026-08-25
15
31
months
8
16
months
Yes
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
For medical devices, COFEPRIS recognizes as Autoridades Regulatorias de Referencia (ARR): countries that are members of the IMDRF Management Committee, and full members of the Medical Device Single Audit Program (MDSAP) for Good Manufacturing Practice certificates. Device registrations can be obtained through equivalence with prior ARR approvals via trámite COFEPRIS-04-050.
Effective from 2025-07-19
Effective date assumed day after DOF publication (18-07-2025) per standard transitorio wording of this type of Acuerdo; the mechanism is also described on the COFEPRIS reliance page.
Regulatory reference
Rule 67 names the reference countries and schemes whose market authorisations DRAP relies on: USA, Japan, Australia, Canada, Austria, Belgium, Denmark, France, Germany, Ireland, Italy, Netherlands, Norway, Spain, Sweden, Switzerland and United Kingdom, or devices pre-qualified by the World Health Organization, or CE marked by conformity assessment bodies (CABs) notified in the NANDO database under the relevant European directive for medical devices, subject to evidence and supporting documents.
Effective from 2018-01-16
Prior approval / evidence record
For IVDs, DINAVISA decides within 30 business days for products manufactured nationally or in a country of Annex I, within 45 business days for products manufactured outside Annex I but registered and commercialised in an Annex I country (which must additionally file the foreign registration certificate and free-sale certificate), and within 120 business days for other imports. Annex I names high-surveillance and adequate-surveillance authorities and the full MERCOSUR members; the United States and Japan are on it and Korea is not.
Sanitary registration and free-sale certificate in force in an Annex I country — high-surveillance authorities (Germany, Austria, Belgium, Canada, Denmark, Spain, United States, France, Israel, Italy, Japan, Netherlands, United Kingdom, Sweden, Switzerland) or adequate-surveillance authorities (Australia, Chile, Cuba, Finland, Hungary, Ireland, Luxembourg, Mexico, Norway, New Zealand); Annex I also lists full MERCOSUR members (Argentina, Brazil, Paraguay, Uruguay) and PAHO/WHO reference authorities
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Source language: Spanish. Translation of the quoted Annex I heading and entries: 'Countries with High and Adequate Sanitary Surveillance Authorities (Law 3283/07 Article 11)' / 'Countries with high sanitary surveillance regulatory authorities: Germany, Austria, Belgium, Canada, Denmark, Spain, United States, France, Israel, Italy, Japan, Netherlands, United Kingdom, Sweden and Switzerland.' / 'Full MERCOSUR members: Argentina, Brazil, Paraguay and Uruguay.' The excerpt is taken from the resolution's own Annex I; Art. 6 supplies the 30- and 45-business-day clocks.
Prior approval / evidence record
PAHO/WHO reference authority or IMDRF Management Committee member authority
Yes
Operative for class II, III and IV IVDs, which enter the Proceso Simplificado de Registro Sanitario under Resolución DINAVISA N° 44/2024 with a 15-business-day validation and approval by positive silence.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
Class II, III and IV in-vitro diagnostic products already authorised and commercialised in countries regulated by PAHO/WHO reference regulatory authorities, by authorities of IMDRF Management Committee member countries, or by authorities with bilateral agreements with DINAVISA enter the Proceso Simplificado de Registro Sanitario (PSR). DINAVISA has 15 business days to validate and decide, and approval follows by positive silence if no report is issued.
PAHO/WHO reference regulatory authorities; authorities of IMDRF Management Committee member countries (the IMDRF committee includes US FDA, EU, Japan PMDA/MHLW, Health Canada, TGA, ANVISA, China NMPA, Korea MFDS, Singapore HSA and UK MHRA); authorities with bilateral agreements with DINAVISA
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Effective from 2024-01-30
Source language: Spanish. Translation of the operative part of Art. 2: 'Applications for sanitary registration of In Vitro Diagnostic Products ... that are authorised and commercialised in countries regulated by: PAHO/WHO Reference Regulatory Authorities; Regulatory Authorities of member countries of the Committee of the International Medical Device Regulators Forum - IMDRF; Regulatory Authorities with which bilateral agreements with DINAVISA exist, shall be subject to the Simplified Sanitary Registration Process (PSR).' and 'DINAVISA shall have a term of 15 (fifteen) business days to validate the required documentation and decide thereon. Once the term has elapsed with no report from DINAVISA, the application shall be approved.' Article numbering confirmed by reading the page image of the official PDF.
Prior approval / evidence record
Proceso simplificado de Registro Sanitario (PSR) para productos para diagnóstico de uso in vitro
Class II, III and IV IVDs (Res. 44/2024 Art. 7) already authorised and commercialised by a recognised reference authority are validated in 15 business days with approval by positive silence, instead of the 30, 45 or 120 business days of the ordinary IVD route.
From 30-120 business days down to 15 business days
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Regulatory reference
For free-sale certificate and related evidence purposes, the high-vigilance countries are France, Netherlands, UK, USA, Canada, Japan, Switzerland, Germany, Spain, Australia, Denmark, Italy, Norway, Belgium and Sweden.
D.S. 018-2019-SA subsequently added Austria to this list (as shown on DIGEMID's normas-legales repository).
Prior approval / evidence record
País de Alta Vigilancia Sanitaria (art. 9 D.S. 016-2011-SA): United States, Canada, Japan, Australia, Switzerland, South Korea, United Kingdom, Germany, France, Netherlands, Spain, Italy, Belgium, Portugal, Ireland, Austria, Hungary, Denmark, Norway, Sweden
Yes
The Peruvian route to relying on a foreign approval is documentary, not procedural. A certificate of free sale or a GMP certificate issued by a high-surveillance authority is accepted directly, and if the issuing authority appears on the Resolución Directoral 169-2014-DIGEMID list the document does not need an apostille. Everything else still goes through DIGEMID certification.
None published — the TUPA period is set by class, not by origin
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
For general medical devices, registrations from USA, UK, Australia, Canada, Japan, Norway, Switzerland and all EU member countries are considered under the reliance pathway; for IVD medical devices the same list applies plus Singapore.
Prior approval / evidence record
WHO Prequalification, or quality-system certification from a certification body accredited by a regulatory authority in an IMDRF founding-member country, or any other international organisation recognised by NDA
Yes
Track 2: accepted as a documentary substitution for an IMDRF-country licence under DAR/GDL/028 §4.12.2 — the foreign element that unlocks the route is the quality-system certification and its accreditation rather than a product approval, and no shortened period is published for it.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
A product that is not licensed in an IMDRF founding-member country can still enter Track 2 by producing documented evidence of conformity to an accepted quality system standard from a certification body accredited by a regulatory authority in one of the IMDRF founding member countries, or WHO Prequalification, or any other international organisation recognised by NDA. This is a documentary substitution: the foreign element that unlocks the route is the quality-system certification and its accreditation, not a product approval. NDA's Medical Devices page states the same route for products 'prequalified by WHO or registered in SRA countries'.
WHO Prequalification, or ISO 13485/ISO 13488 (or the country-equivalent QS) certification issued by a certification body accredited by a regulatory authority in an IMDRF founding-member country; more broadly, registration in a country NDA treats as a stringent regulatory authority
Qms Audit Reliance
facilitated
Premarket Review
Yes
Yes
Effective from 2020-08-14
edgeType 'qms_audit_reliance' is reused from the existing vocabulary (4 prior uses): the mechanism is reliance on a third party's quality-system certification rather than on a product approval. NDA's page wording for this route ('Track 2 for Products prequalified by WHO or registered in SRA countries') is carried by the supporting source. The guideline does not define 'SRA'; the page's SRA language and the guideline's 'accredited by a regulatory authority in one of the IMDRF founding member countries' are not identical, and the fact is bounded to what the guideline says.
Prior approval / evidence record
A device already licensed in one of the IMDRF founding-member countries goes into Track 1, which NDA describes as an expedited review with shortened registration timelines whose evaluation process is abridged by the foreign approval. The applicant does not re-submit the full technical dossier: Track 1 requires a covering attestation, abbreviated product and manufacturer details, a notarized copy of the IMDRF-country licence, a Certificate of Analysis confirming compliance to an accepted quality system standard, evidence of repeat sales in the country of manufacture, product samples where practicable, and a completed submission checklist. The approval recognised is the one listed for the country in DAR/GDL/028 Table 2.
Australia: TGA GMPALS licence or CE mark; Canada: appliance licence; European Union: CE mark; Japan: MHLW appliance licence; United States: FDA 510(k) letter
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Effective from 2020-08-14
Excerpt joins the s. 4.12.1 heading with items (d) and (e) of the same list and with Table 2 verbatim, separated by [...]. NDA's Medical Devices page restates the same mechanism in its own words for the customer question: 'Foreign manufacturers entering the Ugandan market can leverage their existing approvals in recognized reference markets (Australia, Canada, European Union countries, Japan, and the United States) with expedited reviews and shortened registration timelines.' That page sentence is the supporting source's contribution and is why this is not marked source-backed-partial.
Prior approval / evidence record
Licence or approval from an IMDRF founding-member country — Australia, Canada, the European Union, Japan, the United States
Yes
Track 1: an abridged evaluation in which the foreign approval carries the technical assessment, with a much smaller submission (attestation, abbreviated product and manufacturer details, notarized copy of the licence, Certificate of Analysis to an accepted quality-system standard, evidence of repeat sales and product samples where practicable). It is an expedited review with shortened registration timelines, but NDA publishes no number for the shortening and the final decision remains NDA's.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
class-c
Class C
high
Circulation number registration (Ministry of Health)
45
45
days
official-verified
Nghị định 98/2021/NĐ-CP on the management of medical devices (as amended by Decrees 07/2023, 96/2023, 04/2025) — Art. 28 declaration for Class A/B and Art. 32 appraisal periods for Class C/D
https://vanban.chinhphu.vn/?pageid=27160&docid=204442
2022-01-01
2026-08-29
4
5
months
10
10
working-days
No
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
class-d
Class D
highest
Circulation number registration (Ministry of Health)
45
45
days
official-verified
Nghị định 98/2021/NĐ-CP on the management of medical devices (as amended by Decrees 07/2023, 96/2023, 04/2025) — Art. 28 declaration for Class A/B and Art. 32 appraisal periods for Class C/D
https://vanban.chinhphu.vn/?pageid=27160&docid=204442
2022-01-01
2026-08-29
4
5
months
10
10
working-days
Yes
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
Origin Country Evidence
Evidence Only
Disclosure of marketing approval in a SADC state, WHO Prequalification, US FDA approval, CE marking, or approval in any IMDRF member state
ZAMRA's device application form requires the applicant to disclose its foreign approvals: it must list the SADC states where the medical device has obtained marketing approval, attaching documentation, and state whether the device is WHO prequalified, US FDA approved, CE marked or approved in any IMDRF member state, attaching valid documentation. A separate dossier item requires documentary proof of registration of the product in other countries, specifically those in the SADC region. None of these approvals, however, gives a shortened or substitute route in the guidelines: the non-IVD guideline states only that an application 'shall be evaluated on a first come first serve basis unless expedited evaluation has been authorised by the Authority', and neither the non-IVD nor the IVD guideline provides that a WHO, FDA, CE or IMDRF approval triggers that authorisation or replaces any part of ZAMRA's assessment. An FDA or CE holder therefore still files the full ZAMRA dossier and obtains a Zambian marketing authorisation on ZAMRA's own evaluation. This is disclosure and evidence, not reliance.
Product Marketing
Yes
Yes
Effective from 2024-06-21
Verbatim from Annex I: 'List the SADC states where the medical device has obtained marketing approval (Attach documentation)' and 'Is the device WHO prequalified, US FDA approved, CE Marked or approved in any IMDRF member state? If so attach valid documentation'. Non-IVD guideline section 1(i): 'An application shall be evaluated on a first come first serve basis unless expedited evaluation has been authorised by the Authority.' Definition: '“expedited evaluation” means the express evaluation of a product application within a 90 – day period'.
Prior approval / evidence record
WHO Prequalification; US FDA approval; EU CE marking; approval in any IMDRF member state
No
Disclosure only. The Annex I application form requires the applicant to state whether the device is WHO prequalified, US FDA approved, CE marked or approved in any IMDRF member state and to attach valid documentation, but neither the non-IVD nor the IVD guideline attaches any procedural consequence — no shortened clock, no abridged dossier and no substitute for ZAMRA's own evaluation.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
geo:che
EU CE under MDR/IVDR
Unilateral Recognition
Direct With Local Obligations
Product Marketing
No
No
Switzerland unilaterally recognises the CE label: a device lawfully CE-marked under the EU system may be placed on the Swiss market without a separate Swiss conformity-assessment or authorisation step, subject to local obligations (CH-REP, actor and device registration, languages, vigilance, market surveillance).
Recognition is unilateral following the lapse of the mutual recognition agreement; Swissmedic states it 'follows what is specified for the European Union (EU) system of compliance assessment and certification'.
Prior approval / evidence record
EU CE Mark (MDR)
Yes
Full recognition - immediate Swiss market access
Immediate
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
Unilateral recognition of EU/EEA certificates
The device chapter of the EU-Switzerland MRA has not applied since 26 May 2021 and has not been restored; Switzerland instead recognises EU/EEA notified-body certificates one-way under MepV Art. 25(4), which is why a CH-REP and Swiss labelling are still required
No second conformity assessment
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
FDA 510(k)
No
Documentation can support Swiss application
Indirect
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Regulatory reference
Certificates issued by bodies designated under EU law and established in an EU or EEA state that are not recognised through an international agreement are treated as equivalent to certificates of Swiss designated bodies, provided it is credibly demonstrated that the applied conformity assessment procedures satisfy Swiss requirements and the body has qualifications equivalent to those required in Switzerland.
Also underpins the legacy-transition option to apply to an EU/EEA notified body (Arts. 100-101 MedDO).
Prior approval / evidence record
class-i
Class I
low
Self-declaration (no conformity assessment body)
0
0
days
official-verified
Medizinprodukteverordnung (MepV, SR 812.213), Stand 1. Juli 2026 — Art. 23 conformity assessment by reference to EU MDR, Art. 25(4) equivalence of EU/EEA notified-body certificates
https://www.fedlex.admin.ch/eli/cc/2020/552/de
2026-07-01
2026-08-29
3
5
months
1
2
months
No
No
No
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Regulatory reference
Switzerland recognises only the EU CE conformity route (unilateral recognition of CE-marked devices under the MedDO/IvDO); a China NMPA registration certificate gives no route to the Swiss market and is not assessed. A Chinese manufacturer needs CE conformity assessment plus a Swiss authorised representative and Swissmedic registration duties.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
switzerland
All NMPA classes -> all Swiss classes
No Reliance Route
none
Product Marketing
Yes
Yes
Source passage: Switzerland unilaterally recognises the CE label for medical devices (existing verified source section).
Prior approval / evidence record
EU CE Mark (MDD)
Yes
Recognized until certificate expiry
Immediate
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
EU CE Mark Recognition
Full recognition of EU CE marked devices until 2028
Immediate market access
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
What review, validation, and applicant stop-clock rules apply?
In clinical investigation procedures under KlinV-Mep, if the ethics committee requests additional information under Art. 10(2), the decision period is suspended until the information is received (stop-clock).
Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?
Individual products that have not undergone the applicable conformity assessment procedure may be placed on the market and used without Swissmedic authorisation if: they serve to remedy life-threatening conditions or permanent impairment of a body function; no conforming product is available for the intended purpose; they are applied to individual persons exclusively by medical professionals; the applying professional has informed the person concerned of the non-conformity and its risks; and the person concerned has consented.
Art. 22(3): separate exceptions possible for products used exclusively within the army.
On reasoned application, Swissmedic may authorise the placing on the market and putting into service of a specific product in the interest of public health or patient safety or health, even though the applicable conformity assessment procedure under Art. 23 was not carried out or the language requirements of Art. 16(2) are not met.
How are deficiencies answered, clocks handled, and decisions escalated or appealed?
Insofar as the Therapeutic Products Act does not provide otherwise, administrative procedure and legal protection are governed by the Federal Act of 20 December 1968 on Administrative Procedure (VwVG, SR 172.021), the Administrative Court Act and the Federal Court Act - Swissmedic decisions follow the ordinary Swiss administrative justice track.
In clinical investigation procedures, the ethics committee confirms receipt of the application within 10 days and notifies formal deficiencies, setting a 10-day period to cure them (with notice that the application will not be entered upon if not corrected in time); the decision is issued within 40 days of confirmation of formally correct documents.
Which UDI, device listing, database, and traceability duties apply?
IVD UDI affixing deadlines: Class D from 26 May 2023; Classes B and C from 26 May 2025; Class A from 26 May 2027.
The manufacturer (or system/procedure-pack assembler) must assign a UDI to the product, system or procedure pack and all higher levels of packaging before placing on the market (custom-made devices exempt) and affix it to the labelling; shipping containers are not higher packaging levels. Affixing deadlines: implantable devices and Class III from 26 May 2021; Classes IIa and IIb from 26 May 2023; Class I from 26 May 2025; reusable products requiring the UDI on the product itself: 2 years after the respective class date.
What is reportable, by whom, where, in what format, and by what deadline?
The manufacturer of an IVD made available on the Swiss market must report to Swissmedic serious incidents in connection with the product occurring in Switzerland, as soon as they become aware, and field safety corrective actions taken in Switzerland; exceptions, modalities, periodic summary reporting, trend reporting and analysis follow Art. 24(5) and Arts. 82-84 EU-IVDR. Where a CH-REP is required under Art. 44 IvDO, the CH-REP bears reporting responsibility and must submit trend reports and final reports ex officio.
The manufacturer of a product made available in Switzerland, or the person assembling systems or procedure packs and making them available in Switzerland, must report to Swissmedic: (a) serious incidents in connection with the product occurring in Switzerland, as soon as they become aware of them; and (b) field safety corrective actions taken in Switzerland. Exceptions, modalities, periodic summary reporting, trend reporting and analysis follow Art. 27(5) and Arts. 87-89 EU-MDR. Where a CH-REP is required, the CH-REP bears reporting responsibility and must submit trend reports and final reports ex officio.
Exact day counts (immediately, 2, 10, 15 days) follow Arts. 87-89 EU-MDR via Art. 66(2) MedDO; the EU-MDR article text itself was not opened in this session, so specific deadlines are not quoted.
Reports to Swissmedic must be made electronically and in machine-readable form (Art. 66(5) MedDO); Swissmedic designates the forms: serious incidents are reported with the MIR form (in English or a Swiss national language) by e-mail as XML plus PDF to materiovigilance@swissmedic.ch; the scope covers serious incidents that occurred in Switzerland or Liechtenstein; where the manufacturer or SPPP is not established in Switzerland or Liechtenstein, the authorised representative assumes reporting responsibility.
switzerland:ivd
switzerland
Switzerland IVD risk classification
a
IVD Class A
low
b
IVD Class B
medium
c
IVD Class C
high
d
IVD Class D
highest
Swissmedic
official-source-verified
Ordinance on In Vitro Diagnostic Medical Devices (IvDO), Art. 14 (Klassifizierung)
https://www.fedlex.admin.ch/filestore/fedlex.data.admin.ch/eli/cc/2022/291/20250101/20250101/de/pdf/a.pdf
2026-08-25
switzerland:medical-device
switzerland
MedDO classes I, Is, Im, Ir, IIa, IIb and III.
i
Class I
low
is
Class Is
low
im
Class Im
low
ir
Class Ir
low
iia
Class IIa
medium
iib
Class IIb
high
iii
Class III
highest
Swissmedic
official-source-verified
Medical Devices Ordinance (MedDO), Art. 15 (Klassifizierung)
https://www.fedlex.admin.ch/filestore/fedlex.data.admin.ch/eli/cc/2020/552/20231101/20231101/de/pdf/a.pdf
2026-08-25
Switzerland
switzerland
CH
🇨🇭
Swiss Agency for Therapeutic Products
Swissmedic
europe
2
4-class (I, IIa, IIb, III) - EU MDR aligned
class-i
Class I
low
Self-declaration (no conformity assessment body)
0
0
days
official-verified
Medizinprodukteverordnung (MepV, SR 812.213), Stand 1. Juli 2026 — Art. 23 conformity assessment by reference to EU MDR, Art. 25(4) equivalence of EU/EEA notified-body certificates
https://www.fedlex.admin.ch/eli/cc/2020/552/de
2026-07-01
2026-08-29
3
5
months
1
2
months
No
No
No
EU CE Mark Recognition
Full recognition of EU CE marked devices until 2028
Immediate market access
Unilateral recognition of EU/EEA certificates
The device chapter of the EU-Switzerland MRA has not applied since 26 May 2021 and has not been restored; Switzerland instead recognises EU/EEA notified-body certificates one-way under MepV Art. 25(4), which is why a CH-REP and Swiss labelling are still required
No second conformity assessment
EU CE Mark (MDR)
Yes
Full recognition - immediate Swiss market access
Immediate
EU CE Mark (MDD)
Yes
Recognized until certificate expiry
Immediate
FDA 510(k)
No
Documentation can support Swiss application
Indirect
Yes
Swiss Authorized Representative (CH-REP)
No
Not accepted but ISO 13485 required
5 years (aligned with CE certificate)
2026-08-29
partially-verified
Medizinprodukteverordnung (MepV, SR 812.213), Stand 1. Juli 2026 — Art. 23 conformity assessment by reference to EU MDR, Art. 25(4) equivalence of EU/EEA notified-body certificates
https://www.fedlex.admin.ch/eli/cc/2020/552/de
2026-07-01
2026-08-29
Verordnung über klinische Versuche mit Medizinprodukten (KlinV-Mep, SR 810.306), Stand 20. Mai 2025 — Art. 12, 13 and 19 procedural deadlines
https://www.fedlex.admin.ch/eli/cc/2020/553/de
2025-05-20
2026-08-29
2026-08-29
default
planning-template
Maintained planning steps and estimates, not verified regulator deadlines.
1
Pre-Submission Preparation
Gather technical documentation, quality management system (QMS) records, and clinical data required by Swissmedic. Appoint a Swiss Authorized Representative (CH-REP).
1-3 months
📋
2
Application Submission
Submit complete registration dossier to Swissmedic including device description, risk analysis, and testing reports.
1-2 weeks
📤
3
Administrative Review
Swissmedic reviews application for completeness. May request additional documents or clarifications.
2-4 weeks
🔍
4
Technical Evaluation
In-depth technical assessment of device safety and performance. Swissmedic may issue questions.
0 days
⚙️
5
Registration Approval
Upon successful review, Swissmedic issues Switzerland market authorization certificate.
1-2 weeks
✅
Switzerland
switzerland
CH
Swissmedic
200
200
CHF
No
200
10000
CHF
No
swissdamed-basic-fee-first-udi-di
swissdamed Basic Fee - First UDI-DI
CHF
200
CHF 200
First UDI-DI per manufacturer per calendar year
official-verified
https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank/registrierungsgebuehr.html
Swissmedic swissdamed device registration fee
2026-07-01
2026-08-25
exact-current
swissdamed-unit-fee-additional-udi-di
swissdamed Unit Fee - Additional UDI-DI
CHF
20
CHF 20
Each additional UDI-DI in the same calendar year
Maximum CHF 10,000 per manufacturer per year
official-verified
https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank/registrierungsgebuehr.html
Swissmedic swissdamed device registration fee
2026-07-01
2026-08-25
exact-current
swissdamed-registration-first-device
swissdamed device registration - first device per year
CHF
200
CHF 200
Annual, per manufacturer
Effective 1 July 2026; capped at CHF 10,000 per year per manufacturer or assembler of systems/procedure packs (no additional cost from 492 devices per year).
exact-current
official-verified
https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank/registrierungsgebuehr.html
Swissmedic swissdamed device registration fee
2026-07-01
2026-08-25
swissdamed-registration-additional-device
swissdamed device registration - each additional device
CHF
20
CHF 20
Annual, per additional device
exact-current
official-verified
https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank/registrierungsgebuehr.html
Swissmedic swissdamed device registration fee
2026-07-01
2026-08-25
2026-08-25
official-verified
Swissmedic swissdamed device registration fee
https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank/registrierungsgebuehr.html
2026-07-01
2026-08-25
2026-08-25
exact-current
Yes
switzerland
Switzerland
low
swiss-medical-electrical-emc-evidence
Swiss medical electrical/EMC evidence
Medical Electrical Safety
Included In Medical Registration
Finished Device
Designated-body certificates (per Annexes IX-XI EU-MDR) must be issued in one of the three official languages or English, contain at least the Annex XII information and are valid for a maximum of 5 years, extendable on application by up to 5 years per re-assessment and repeatedly (MedDO Art. 25-26; identical rule for IVD certificates IvDO Art. 22); ancillary federal law (Electricity Act, Metrology Act, Product Safety Act, Radiation Protection Act) is triggered alongside device certification per the MedDO preamble.
unresolved
bakom-ofcom-radio-market-conformity
BAKOM/OFCOM radio market conformity
Radio Spectrum
Mandatory If Feature
Radio Equipment
candidate
swiss-or-accepted-ce-conformity-marking
Swiss or accepted CE conformity marking
Radio Spectrum
Evidence Only No Separate Certificate
Radio Equipment
candidate
foph-radiation-authorization
FOPH radiation authorization
Ionizing Radiation
Mandatory If Feature
Product Or Use Site
unresolved
BAKOM/OFCOM
market access for radiocommunications equipment
https://www.bakom.admin.ch/en/market-access-of-radiocommunications-equipment
BAKOM/OFCOM
equipment marking
https://www.bakom.admin.ch/en/equipment-marking
Fedlex
MedDO designated-body certificate rules and ancillary legal bases
https://www.fedlex.admin.ch/filestore/fedlex.data.admin.ch/eli/cc/2020/552/20231101/20231101/de/pdf/a.pdf
