Swissmedic recently inspected local importers for compliance. The results can be found: HERE

The inspection results

Thirty importers were inspected. Of those, Swissmedic found that:

• • 18 out of 30 importers performed incomplete product checks
  • Of 8 out of 30 importers, the importer information was incomplete
  • At 8 out of 30 importers, the storage and transport conditions were inadequate
  • 3 out of 30 importers had deficiencies in the recording and forwarding of complaints

While most importers were aware of their legal obligations, including reporting requirements, there were deficiencies related to proper verification of products, identifying themselves per Swissmedic’s requirements, and storage and conditions.

Swissmedic has given the importers a deadline to address the deficiencies.

Why does this matter to you?

While the above mentioned obligations and findings fall on the importer, it impacts you as the manufacturer if they are not:

• Storing or transporting your products correctly
• Ensuring proper traceability of your devices
• Forwarding you (and your Swiss Authorized Representative, who is responsible for vigilance reporting) complaints

As well, if this specific group of inspected importers do not resolve their findings by the deadline, Swissmedic “will take appropriate measures”, which could impact the distribution and sale of your devices in Switzerland.

It would, therefore, behoove manufacturers to ensure that their Swiss importers understand their requirements under the MedDO and IvDO and are in compliance.

For more information

The same above link has the results from Swissmedic’s inspection of Swiss-based manufacturers and Authorized Representatives, if of interest.

Further, the requirements for Swiss importers (including labeling and registration) can be found: HERE