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.
Last updated 13 March 2026
Register Class B medical device via abridged route
Follow this guide to find out the documents, fees and processing time needed to complete the abridged registration of Class B medical devices.
Register Class B medical device via full route
Follow this guide to find out the documents, fees and processing time needed to complete the full registration of Class B medical devices.
Register Class B medical device via immediate route
Follow this guide to find out the documents, fees and processing time needed to complete the immediate registration of Class B medical devices.
Register Class C medical device via abridged route
Follow this guide to find out the documents, fees and processing time needed to complete the abridged registration of Class C medical devices.
Register Class C medical device via expedited route
Follow this guide to find out the documents, fees and processing time needed to complete the expedited registration of Class C medical devices.
Register Class C medical device via full route
Follow this guide to find out the documents, fees and processing time needed to complete the full registration of Class C medical devices.
Register Class C medical device via immediate route
Follow this guide to find out the documents, fees and processing time needed to complete the immediate registration of Class C medical devices.
Register Class D medical device via abridged route
Follow this guide to find out the documents, fees and processing time needed to complete the abridged registration of Class D medical devices.
Register Class D medical device via expedited route
Follow this guide to find out the documents, fees and processing time needed to complete the expedited registration of Class D medical devices.
Register Class D medical device via full route
Follow this guide to find out the documents, fees and processing time needed to complete the full registration of Class D medical devices.
Register Class D medical device with a registrable drug in a secondary role via abridged route
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.
Register Class D medical device with a registrable drug in a secondary role via full route
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.