SWISS AUTHORISED REPRESENTATIVE
FOR FOREIGN MANUFACTURERS OF
MEDICAL DEVICES
Since 26 May 2021, Switzerland is considered a third country for the EU.
Mutual recognition of conformity assessment procedures no longer applies. Foreign manufacturers of medical devices must appoint a "Swiss Authorised Representative".
A Swiss Authorised Representative is a natural or legal person established in Switzerland who is appointed in writing by a manufacturer established abroad to perform on his behalf the obligations under SR 812.213 Medical Devices Ordinance MeDO as Swiss Authorised Representative.
Inspera GmbH is registered by the Swiss Authority Swissmedic as a Swiss Authorised Representative for foreign manufacturers.
As one of the founding and main partners of www.ch-rep.com platform, we are appointed globally by foreign manufacturers as their Swiss Authorised Representative.
We also support importers and distributors who wish to assume the role of Swiss Authorised Representative themselves.
Further Information can be found at www.ch-rep.com.
Request further information on the Swiss Authorised Representative for Medical Devices
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