Registration guides

Once you have determined the evaluation route and risk class of your medical device, use the relevant guide to find out the documents, fees and processing time required to complete the registration.

Class B full registration Follow this guide to find out the documents, fees and processing time needed to complete the full registration of Class B medical devices. Class B abridged registration Follow this guide to find out the documents, fees and processing time needed to complete the abridged registration of Class B medical devices. Class B immediate registration Follow this guide to find out the documents, fees and processing time needed to complete the immediate registration of Class B medical devices. Class C full registration Follow this guide to find out the documents, fees and processing time needed to complete the full registration of Class C medical devices. Class C abridged registration Follow this guide to find out the documents, fees and processing time needed to complete the abridged registration of Class C medical devices. Class C expedited registration Follow this guide to find out the documents, fees and processing time needed to complete the expedited registration of Class C medical devices. Class C immediate registration Follow this guide to find out the documents, fees and processing time needed to complete the immediate registration of Class C medical devices. Class D full registration Follow this guide to find out the documents, fees and processing time needed to complete the full registration of Class D medical devices. Class D abridged registration Follow this guide to find out the documents, fees and processing time needed to complete the abridged registration of Class D medical devices. Class D expedited registration Follow this guide to find out the documents, fees and processing time needed to complete the expedited registration of Class D medical devices. Class D with a registrable drug in a secondary role full registration Follow this guide to find out what is needed to complete the full registration for Class D devices with a registrable drug in a secondary role. Class D with registrable drug in secondary role abridged registration Follow this guide to find out what is needed to complete the abridged registration for Class D devices with a registrable drug in a secondary role.