Authorized Representative (CH-REP) for market access of international medical device manufacturers in Switzerland
Dipl.-Ing. (FH) Jan Möstel – Swiss Authorized Representative
5430 Wettingen (Switzerland)New on Amplifa
About Jan Möstel – Swiss Authorized Representative
Jan Möstel is a Swiss sole proprietorship based in Wettingen that represents international manufacturers of medical devices and IVDs as the authorized representative (Swiss Authorized Representative, CH-REP) in accordance with the Medical Devices Ordinance (MepV). Since 31.12.2021, the designation of an authorized representative residing in Switzerland has been a prerequisite for foreign manufacturers to import medical devices into Switzerland. The service offering includes CH-REP representation, review of technical documentation and declarations of conformity including CE marking, vigilance and post-market surveillance (FSCA reports, PSUR, trend reporting), regulatory consulting and audits, product registration in swissdamed (CHRN) including UDI data management, and training on Swiss regulatory affairs. The owner is Dipl.-Ing. (FH) Jan Möstel, a Dental Technologist (FH Osnabrück), with over 18 years of experience in quality management across seven industries. The company is registered with Swissmedic under the CHRN number CHRN-AR-20000756 and serves industries such as medical technology, diagnostics, dental, aerospace, automotive, and pharmaceutical suppliers.
- Site
- Wettingen
- Processes
- CH-REP representation (authorized representative in accordance with MepV/IvDV), Review of technical documentation / conformity assessment, CE marking, Vigilance & Post-Market Surveillance (FSCA reports, PSUR, trend reporting), Consulting & audits (gap analyses, internal audits, Swissmedic inspection support), Registration & UDI (swissdamed/CHRN, UDI data management), Training & communication (Swiss regulatory affairs, coordination of, CH-REP representation in accordance with MepV/IvDV, Technical documentation / review of declarations of conformity
- Certificates
- CHRN registration (Swiss Authorized Representative in accordance with MepV), CHRN registration with Swissmedic (CHRN-AR-20000756), ISO 13485 (competence), ISO 9001 (competence), ISO 27001 (competence)
- Industries
- Medical Technology, Diagnostics/IVD, Dental, Aerospace, Automotive, Pharmaceutical Suppliers
- 01
CH-REP representation in accordance with MepV/IvDV
- 02
Review of declaration of conformity and technical documentation
- 03
Product registration with Swissmedic (swissdamed/CHRN) and UDI data management
- 04
Vigilance and post-market surveillance incl. PSUR
- 05
Consulting, audits, and training
Location
Wettingen
CHBusiness address / seat of the sole proprietorship
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| CH-REP representation (authorized representative in accordance with MepV/IvDV)Engineering | – | – | – | – | – |
| Review of technical documentation / conformity assessment, CE markingEngineering | – | – | – | – | – |
| Vigilance & Post-Market Surveillance (FSCA reports, PSUR, trend reporting)Engineering | – | – | – | – | – |
| Consulting & audits (gap analyses, internal audits, Swissmedic inspection support)Engineering | – | – | – | – | – |
| Registration & UDI (swissdamed/CHRN, UDI data management)Engineering | – | – | – | – | – |
| Training & communication (Swiss regulatory affairs, coordination ofEngineering | – | – | – | – | – |
Additional services
Reference customers
Qualification and Registration
The activity as authorized representative meets the requirements of the MepV: completed degree, over 18 years of QM experience in the medical device sector, and registration with Swissmedic (swissdamed, CHRN-AR-20000756). Competencies include ISO 13485, ISO 9001, ISO 27001, MDR/IVDR, and risk management.
| Evidence | Wettingen |
|---|---|
| CHRN registration with Swissmedic (CHRN-AR-20000756) | |
| ISO 13485 (competence) | |
| ISO 9001 (competence) | |
| ISO 27001 (competence) |
History
- 2021
Start of supporting international manufacturers with Swiss market access as a registered CH-REP; CH-REP obligation in accordance with MepV since 31.12.2021
- 2026
Imprint/privacy policy as of April 2026