Swiss Authorized Representative (CH-REP)
for Medical Devices and In Vitro Diagnostic Devices
The Swiss Authorized Representative is required by the Swiss Authorities for Manufacturers of Medical Devices & In Vitro Diagnostic Devices located outside Switzerland. In order to place medical devices in the Swiss market, you need to appoint a Swiss Authorized Representative (CH-REP) according to the MedDO and IvDO.
Authorised representative; “natural or legal person in Switzerland who has been mandated in writing by a manufacturer established in a foreign country to act on the manufacturer’s behalf in relation to specified tasks in accordance with Art. 4 para. 1 let. g from MedDO and with Art. 4 para. 1 let. f from IvDO .”
As a Swiss Authorized Representative, MDSS is the main contact for the Swiss Authority and responsible for the formal and safety-related issues connected with the placing of medical devices in the Swiss market.
Swiss Authorized Representative (CH-REP) tasks:
- Verification of Technical Documentation – Check that declarations of conformity and TD have been drawn up and that conformity assessment procedures have been carried out (certificates)
- Registration of economic operators
- Traceability of devices
- Report serious incidents and safety corrective actions in Switzerland to Swissmedic, trend reports
- Immediate forwarding of complaints and reports about suspected incidents to the Manufacturer
- Register of complaints, non-conforming devices, recalls and withdrawals
- Cooperate with Swissmedic in all preventive or corrective actions
- Documents retention requirements
Contact MDSS now
As your Swiss Authorized Representative (CH-REP), we are dedicated to guiding you through all aspects of the Swiss regulatory requirements and regulations.
We can apply for a Free Sales Certificate (FSC) in Switzerland on you behalf!
** From SWISSMEDIC: “If the manufacturer of a medical device does not have its registered place of business in Switzerland, its products may only be placed on the market once an authorised representative domiciled in Switzerland has been appointed (Art. 51 para. 1 MedDO and Art. 44 para. 1 IvDO). This also applies to manufacturers with their registered place of business in the EU.”
