Swissmedic recently inspected local importers for compliance. The results can be found: HERE
Thirty importers were inspected. Of those, Swissmedic found that:
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.
While the above mentioned obligations and findings fall on the importer, it impacts you as the manufacturer if they are not:
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.
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