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) requirements
The UK regulatory framework diverges from both MedDO and EU MDR in several areas. Always verify the current UK requirements on the MHRA website.
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
Official Sources
- MHRA — UK medical devices
- TGA — Australian medical devices
- RAPath AU — Australian regulatory reference
- RAPath EU — EU regulatory reference
AI-assisted navigation aid only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.