Announcements on market control issues

18.10.2023

Swissmedic reviews Swiss importers (PDF, 1 MB, 18.10.2023)Swissmedic reviewed 30 importers of medical devices for compliance with legal requirements.

22.06.2023

Request to check mandates relating to ECM certifications (PDF, 215 kB, 22.06.2023)Swissmedic requests Swiss authorised representatives (CH-REP) to check their mandates with regard to ECM certifications. The following letter was sent to all Swiss authorised representatives registered with Swissmedic.

27.03.2023

Swissmedic inspects Class I manufacturers in Switzerland (PDF, 3 MB, 27.03.2023)Swissmedic inspected 27 Class I medical device manufacturers in Switzerland regarding compliance with the new requirements and market observations

03.10.2022

Swissmedic inspects Swiss authorised representatives (CH-REP) (PDF, 951 kB, 03.10.2022)Swissmedic carried out systematic, focused inspections of Swiss authorised representatives (CH-REP) in the first half of 2022 to check their implementation of the provisions in the market.

12.03.2021
09.03.2021
27.11.2020




https://www.swissmedic.ch/content/swissmedic/en/home/medical-devices/market-surveillance-of-medical-devices/announcements-on-market-control-issues.html