May 16, 2022 | Basic page

AMDF Resources

Guidelines for inspection

 

                         Guidelines for registration  
Guidelines for inspection of manufacturing site(s) for assessment of the quality management system of medical devices based on ISO 13485:2016 - English | French     Guidelines for registration of medical devices establishments - English | French  
         
Guidelines on import     Guidelines on regulatory requirements  
Guidelines on import and export of medical devices including in-vitro diagnostic medical devices - English | French     Guidelines on regulatory requirements for issuance of market authorization of medical devices including in-vitro diagnostic medical devices - English | French