Swiss Authorized Representative (CH-REP)
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.
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.
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.
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.
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.
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