Switzerland medical device registration timeline
Source-linked clocksSwiss Agency for Therapeutic Products (Swissmedic) review clocks and end-to-end planning ranges, using the 4-class (I, IIa, IIb, III) - EU MDR aligned classification system.
| Class / pathway | Review clock | Planning total | With prior approval | Provenance |
|---|---|---|---|---|
| Class I(Self-declaration (no conformity assessment body)) MepV Art. 23 applies the EU MDR conformity assessment procedures, so a Class I device that is not sterile, has no measuring function and is not a reusable surgical instrument is self-declared with no body involved and no review clock | 0 days | 3-5 months | 1-2 months | Verified |
Review clocks exclude applicant hold time · planning totals are estimatesSwitzerland Medical Device Registration Process
Step-by-step Swissmedic registration process. Total estimated timeline: 3-5 months.
Step 1: Pre-Submission Preparation
1-3 monthsGather technical documentation, quality management system (QMS) records, and clinical data required by Swissmedic. Appoint a Swiss Authorized Representative (CH-REP).
Step 2: Application Submission
1-2 weeksSubmit complete registration dossier to Swissmedic including device description, risk analysis, and testing reports.
Step 3: Administrative Review
2-4 weeksSwissmedic reviews application for completeness. May request additional documents or clarifications.
Step 4: Technical Evaluation
0 daysIn-depth technical assessment of device safety and performance. Swissmedic may issue questions.
Step 5: Registration Approval
1-2 weeksUpon successful review, Swissmedic issues Switzerland market authorization certificate.
Full recognition of EU CE marked devices until 2028
Eligibility: Valid EU MDR CE Mark, MDD CE Mark until expiry
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
Eligibility: Certificate from a body designated under EU law and established in an EU or EEA state, Procedures must meet Swiss requirements and the body must hold equivalent qualification
- Swiss Authorized Representative (CH-REP) for foreign manufacturers
- EU MDR technical documentation
- Swiss specific labeling requirements
- Swissmedic registration
- Actor registration: manufacturers, CH-REPs and importers register in swissdamed within 3 months after first placing a product on the market (MedDO Art. 55; IvDO Art. 88)
- Device registration: swissdamed UDI Devices module live since 18.08.2025; registration mandatory from 1 July 2026, with a transition period until 31 December 2026 for devices placed on the market before then
- Clinical investigations (KlinV-Mep Art. 12): the ethics committee confirms receipt and flags formal deficiencies within 10 days, gives the sponsor 10 days to cure them, and decides within 40 days of confirming a formally correct dossier; the clock is suspended while additional information is outstanding
- Multicentre investigations (KlinV-Mep Art. 13): the lead committee confirms receipt within 10 days (each deadline extendable by 5 days on request), the participating committees report their local assessment within 15 days, and the lead committee decides within 40 days
- Swissmedic authorisation (KlinV-Mep Art. 19): receipt confirmed within 10 days, 10-day cure period extendable by 20 days, decision within 45 days of a formally correct dossier and only after the ethics committee has approved, extendable by up to 20 days for first-in-human use or a new manufacturing process; substantial amendments are decided within 38 days (+7)
Reviewed 2026-08-29. End-to-end totals remain planning estimates.