Entering Other Markets from Switzerland
Switzerland → EU (MDR)
Swiss manufacturers accessing the EU market are treated as non-EU manufacturers under EU MDR. Requirements:
- Appoint an EU REP established in an EU member state (EU MDR Art. 11)
- Complete EU MDR conformity assessment (CE marking)
- Register in EUDAMED
- Comply with EU member state labelling language requirements
A CH REP and an EU REP are separate roles. A single organisation can hold both roles only if it is legally established in both Switzerland and an EU member state. Check whether the MRA affects this for Swiss-established manufacturers.
Switzerland → UK (UKCA)
The UK left the EU and has its own UKCA marking system for medical devices. Swiss manufacturers accessing the UK market must:
- Register with the MHRA (Medicines and Healthcare products Regulatory Agency)
- Appoint a UK Responsible Person established in the UK
- Apply the UKCA mark (or CE mark during the transitional period — verify current MHRA position)
- Comply with UK MDR 2002 (as amended) and UKCA marking requirements under the Medical Devices Regulations 2020/1574
The UK regulatory framework diverges from both MedDO and EU MDR in several areas, including notified body procedures, post-market surveillance reporting, and registration timelines. Always verify the current UK requirements on the MHRA website before finalizing your market access strategy.
Switzerland → Other Major Markets
| Market | Regulator | Key Requirement |
|---|---|---|
| Australia | TGA | ARTG registration; Australian Sponsor required |
| Canada | Health Canada | Medical Device Licence; Canadian Importer/Manufacturer |
| Japan | PMDA / MHLW | Japan MAH required; FMR; Shonin/Ninsho approval |
| Singapore | HSA | HSA registration; Singapore RSH required |
| Brazil | ANVISA | ANVISA registration; local representative |
| China | NMPA | NMPA registration; local agent |
Multi-Market Submission Strategy
When planning simultaneous market access across CH, EU, and other jurisdictions:
- Align technical documentation to EU MDR/IVDR (which satisfies MedDO)
- Use a single ISO 13485 QMS scope covering all markets
- Plan labelling for the most demanding language requirements (Swiss DE/FR/IT covers EU requirements in those languages)
- Sequence NB engagement for EU MDR first — Swiss market access follows as a procedural step