Swissmedic monitors the medical device market in a targeted manner and reviews certain focus topics in the Swiss market annually – from economic operators to devices. The aim of these focus campaigns is to raise economic operators’ awareness of their obligations.
The focus topics are selected as part of Swissmedic's annual planning. In doing so, Swissmedic takes into account, among other things, national and international market feedback, the evaluation of suspicious activity reports and queries, and changes in the legal framework. The sample is selected according to certain criteria. The scope of the review varies depending on the topic and the data pool available.
The cantonal therapeutic product authorities and the Office for Health of Liechtenstein, in collaboration with Swissmedic, inspected the use of fillers in 82 clinics, medical practices, and cosmetic studios.
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.
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.
