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Medical device risk classification tool

Find out the risk classification of your medical device for grouping and registration.

Before you begin, please check if your product is a medical device in Singapore.

Medical device registration and licensing requirements



1

What type of medical device are you registering?

Note: For embedded software, where it controls or influences the intended output of a separate IVD medical device, it will have the same class as the IVD medical device itself. For standalone software, when it is not incorporated in an IVD medical device, it is classified in its own right.

Health Sciences Authority

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