News about GMP/cGMP

05.07.2021

Swissmedic: Information sheet on the Swiss Authorised Representative (CH-REP) for medical devices

Swissmedic: Information sheet on the Swiss Authorised Representative (CH-REP) for medical devices

The aborted negotiations between Switzerland and the EU on the institutional framework agreement (we reported) are casting their shadow: new regulations are needed to ensure the safe supply of medical devices within Switzerland. However, not only Swiss manufacturers are affected. Medical device manufacturers who are not domiciled in Switzerland but who place products on the market there must also mandate an authorized representative in Switzerland.


At the end of June, Swissmedic published an information sheet on the mandating of a Swiss authorised representative for medical devices. Point 2 states:  

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). This also applies to manufacturers with their registered place of business in the EU.

The name and address of this so-called "Swiss authorized representative"(CH-REP) must be indicated legibly next to the "CH-REP" symbol on the product packaging. The "CH-REP" symbol is available for download.  

The following transition periods apply according to Art. 104a of the Swiss MepV:  

a. for class III devices, implantable class IIb devices and active implantable medical devices: until December 31, 2021;  

b. for class IIb non-implantable devices and class IIa devices: until March 31, 2022;  

c. for Class I devices: by July 31, 2022.  


Source:

Swissmedic: Medical Devices


 

Comments