Do manufacturers seeking MDSAP certification need to comply with regulations in jurisdictions where they do not market?

A manufacturer only needs to comply with the regulations of the countries where they intend to sell, actively sell, distribute, or make available for use their medical devices. If a medical device has valid marketing authorization in a country, it is considered intended for distribution in that country, even if no sales have occurred.

If MDSAP certification is required before applying for marketing authorization, the manufacturer must inform the AO and request that the relevant country’s requirements be included in the audit. If the manufacturer does not proceed with marketing authorization application in that country after several years, the AO may recommend or decide to remove that country from the audit scope.