Register your device

Grouping of medical devices

Grouping of multiple medical devices for product registration can help save on fees and processing time. Learn about each criteria to help you decide on a possible option for your devices.

Priority Review Scheme

The Priority Review Scheme offers faster registration and market entry for medical devices.

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.

Registration overview of medical devices

Understand the evaluation routes, fees and turn-around-times applicable when you register your medical device.

Summary Reports of Benefit-Risk Assessment

Summary Reports of Benefit-Risk Assessment.