Explore the IVD requirements currently available for Switzerland, organized by topic and linked to official sources.
Common questions about changing a registered IVD in Switzerland. Each question separates published rules from details still awaiting verification.
Does the event require internal documentation, notice, prior approval, transfer, or a new application?
An economic operator registered under IvDO Article 48 must report changes to its registered actor data to Swissmedic within one week. Swissmedic verifies the actor data and issues a CHRN. This is the operator’s reporting duty, not a one-week authority review period.
Under IvDO 19 and incorporated IVDR Annex IX, where Annex IX conformity assessment applies, notify the body that approved the QMS of planned substantial QMS or covered device-range changes; it assesses the proposal and any necessary audits. Under Annex IX 4.11, a change to an approved device that could affect safety, performance or prescribed conditions of use needs the issuing body’s approval. The body decides whether a new conformity assessment or a certificate supplement is required. An identity-data edit does not settle that decision.
Qualifying devices lawfully placed on the market under the former rules or the applicable transition may continue to be made available or put into service under the stated provisions. This is a lawful-placement condition for the actual units; it does not authorise newly changed or non-conforming devices, or automatically extend an old manufacturer/brand label after a transfer. Establish placement date, conformity/legacy status, batch identity and whether the proposed alteration changes that basis.
MDCG 2022-6 distinguishes administrative manufacturer name/address/legal-form changes, including its merger/acquisition example, from significant design/intended-purpose changes for legacy IVDs. This design-change guidance does not itself establish a transfer of conformity responsibility or a universal certificate-succession procedure. Observe the actual certificate conditions and agreed notified-body change procedure; current transition dates must come from amended law, not the old dates printed in this 2022 guide.
Which evidence, local deltas, formats, and signatures are required?
If an export destination requires an FSC, a Swiss-established manufacturer or authorised representative may apply. Update supporting documents for a company name/address change before ordering. The product list identifies the single legal manufacturer, CHRN, product name, REF/article number, class and applicable UDI/conformity references. Current-law and legacy-law products require separate orders; no mixed order is accepted. Orders processed from 1 January 2027 require the listed devices to be registered in swissdamed. This export requirement is separate from an ordinary identity-data update.
For an FSC covering current IvDO devices, supply the declaration of conformity. The table shows no body certificate for non-sterile Class A; sterile A and Classes B, C and D use the relevant class/route certificate entries, with the stated self-test, near-patient and companion-diagnostic conditions. For legacy IVDs, identify both old and current classes and the applicable transition evidence, including the prior 26 May 2022 declaration. The guide does not issue an old-law FSC for an Other-class IVDD device that is now IVDR Class A.
Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?
A foreign manufacturer needs a Swiss-established CH-REP under a written mandate: MedDO Article 51 for MD and IvDO Article 44 for IVD. The responsible manufacturer must meet the applicable conformity, technical-documentation and declaration duties. A different legal manufacturer cannot be substituted by editing the non-updateable manufacturer SRN. A transfer of the CH-REP mandate and its registered devices is a separate representative workflow and does not itself prove that a new manufacturer succeeds to the former manufacturer’s conformity evidence.
For a CH-REP-only change, the current actor, incoming actor and mandate must all have Registered status. The outgoing CH-REP requests the transfer; the incoming CH-REP must approve before the selected transfer date or the request cancels. On that date the mandate and all its registered devices transfer. The legal handover agreement also addresses mandate dates, the date until which the outgoing representative may appear in information, document transfer and complaint forwarding under the incorporated Article 12 rules.
What regulator fee applies to this class, route, event, and date?
A new FSC costs CHF 200 per certificate. Additional resources for product lists over 100 pages may be charged; cancellation/withdrawal or an uncompleted rejected order can attract the stated CHF 100 reduced charge. Swissmedic issues an FSC within 30 days after receipt of the order and complete, appropriate electronic documentation. An incomplete application has a separate 30-day response deadline. These are FSC conditions, not a general identity-variation fee or review clock.
Updating data for an already registered UDI-DI incurs no new device registration fee. Re-registering a discarded UDI-DI is fee-bearing under the current registration schedule. Actor data changes are usually free, but Swissmedic intervention may be charged on actual time at CHF 270 per hour. A new UDI/device registration resulting from the actual identity change must not be presented as a free data update.
Which label and IFU elements, languages, symbols, and translation controls apply?
Under IvDO 15 and incorporated IVDR label requirements, the label identifies the device name/trade name and the manufacturer’s name, registered trade name or trademark and registered-place-of-business address, plus the representative where required and the applicable UDI carrier. Keep the actual post-change device/manufacturer identities consistent with the conformity and registration records. This label-content rule is not an old-stock grace or a permission to use another company’s certificate.
IVD labelling and instructions are generally required in German, French and Italian. The fewer-languages/English exception requires all IvDO 15(3) conditions, including the stated professional-use or Art 9 branch, the user’s professional/language ability and agreement, assured protection and no jeopardy to effective use. For self-testing and near-patient testing, Article 15(8) requires the specified information to be easily understandable in all three languages. The limited placement of CH-REP particulars on an accompanying document has its own Article 15(9) conditions.
Which current form, portal, account, and submission package must be used?
Manufacturers and their CH-REP register the actual device/UDI data in swissdamed under the applicable legislation. The manufacturer SRN in the mandate and device data must match. Device registration became mandatory 1 July 2026 with the published transition to 31 December 2026; specified vigilance cases require immediate registration. The Swiss actor, mandate and device records remain separate from an EU EUDAMED registration, and cannot be assumed to update one another automatically.
For a company synchronised with the UID register/Zefix, correct the company name or address there first; swissdamed receives the update automatically. For a manually registered company or one that opted out of synchronisation, the current FAQ describes the Registered companies pencil editor and directs company-name changes to Swissmedic support. The Actors guide separately directs support for company data that cannot be edited through the actor profile. Other actor details are updated by the authorised user and confirmed. A name/address edit does not establish transfer to a different manufacturer.
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
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
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.
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
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
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
Prior approval / evidence record
País de Alta Vigilancia Sanitaria (art. 9 D.S. 016-2011-SA): United States, Canada, Japan, Australia, Switzerland, South Korea, United Kingdom, Germany, France, Netherlands, Spain, Italy, Belgium, Portugal, Ireland, Austria, Hungary, Denmark, Norway, Sweden
Yes
The Peruvian route to relying on a foreign approval is documentary, not procedural. A certificate of free sale or a GMP certificate issued by a high-surveillance authority is accepted directly, and if the issuing authority appears on the Resolución Directoral 169-2014-DIGEMID list the document does not need an apostille. Everything else still goes through DIGEMID certification.
None published — the TUPA period is set by class, not by origin
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
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
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
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
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
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
Which UDI, device listing, database, and traceability duties apply?
Under IvDO 16(4) and its incorporated IVDR clauses, a new UDI-DI is required for a change that could cause misidentification or traceability ambiguity, including a device name/trade-name or version/model change. An actual catalogue/REF change is not automatically the same thing: assess its effect on identity and traceability. A change to an existing UDI database element that does not require a new UDI-DI must be updated within 30 days. Cosmetic artwork alone is not listed as an automatic new-UDI trigger.
The current swissdamed data dictionary distinguishes manufacturer SRN, Basic UDI-DI, UDI-DI, model/name, trade names and catalogue/REF. Its Updateable legend says blank means No: the REF field FLD-UDID-163 is not updateable in this version for either MD or IVD, while trade names have explicit edit/add/delete permission. The manufacturer SRN is expressly non-updateable in the business rules. Discarding a registered UDI is only for incorrect data that cannot be corrected by updating, not a general workaround for a real commercial or legal-manufacturer change.
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
These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.
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
✅
These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.
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
These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.
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
