Our website uses an automatic service to translate our content into different languages. These translations should be used as a guide only.
How long can an MDSAP certificate reference a jurisdiction where no product is distributed?
MDSAP AOs can issue certificates referencing jurisdictions where the manufacturer does not yet have market authorization.
Recognizing that market entry can take time, such certifications can be extended for a full three years.
If, at the end of three years, the manufacturer has not obtained or applied for market authorization, it is recommended that the requirements for the affected jurisdiction should be removed from the certificate until such time as the manufacturer can demonstrate implementation and effectiveness.