Audits of Medical Device Importers

In late spring, Swissmedic announced in an information letter that it would be conducting inspections of selected importers this year. What is planned?

Swissmedic attributes a central role to importers in Switzerland in the supply of medical devices. According to Swissmedic, the tasks of an importer include:

• Verifying formal product conformity prior to placing medical devices on the Swiss market, including the requirements set out in the transitional provisions
• Compliance with the prescribed storage and transport conditions for these products
• Cooperation with the authorities and economic operators and the provision of documentation in the event of complaints, incidents and safety-related corrective measures, including recalls

Why is Swissmedic initiating these inspections?

Investigations in 2023 showed that some importers found it difficult to comply with the requirements. Swissmedic considers importers to be directly involved in patient interests and the safety of medical devices. As the competent authority responsible for ensuring the efficacy and safety of medical devices, it sees a need for action here.

What is planned?  

Swissmedic explains this in three question and answer sections.

• What are the planned measures? A certain number of importers will be selected at random. These importers will then be inspected, following prior written notification.
• Is it necessary to respond to this information letter from Swissmedic? No, companies that have been selected will be informed by Swissmedic in a separate letter.  
• Where can I find further information? The response refers to a website that provides detailed information for importers, among others.

Finally, Swissmedic states that it can carry out inspections at any time, regardless of this measure.

Conclusion: To ensure the security of the supply chains for medical devices, Swissmedic will be randomly checking selected medical device importers in Switzerland this year.

The full text of the information letter is available on the Swissmedic website.