Medical device registration

You will need to register your medical device before supplying it in Singapore. Find out how to complete your product registration here.

Registration overview Understand the evaluation routes, fees and turn-around-times applicable when you register your medical device. Is it a medical device Tool Check if your device is considered a medical device in Singapore. Risk classification rules and factors Understand the general risk classification system for medical devices, as well as the rules and factors that determine risk class. Risk classification tool Tool Find out the risk classification of your medical device for grouping and registration. Registration and licensing requirements Tool Find out the requirements for your device's registration route and whether you need to apply for a licence. Medical device grouping tool Tool Check if you can group your medical devices for registration. Grouping 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. 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. Priority Review Scheme The Priority Review Scheme offers faster registration and market entry for medical devices. Special Access Routes In specific situations, HSA may allow the import and the supply of unregistered medical devices via approval of Special Access Routes.

Last updated: 31 Dec 2018