For Class B, C, and D medical devices (see Classification of General Medical Devices in Singapore), there are two submission routes in Singapore: the abridged submission route and the full evaluation route. The abridged submission route is only for medical devices that are already registered or approved in two of the following reference agencies: U.S., Japan, European Union, Canada, and Australia. The full evaluation route is for all products not approved in two of the reference agencies.
For more information about Singapore’s medical device registration process, please see Medical Device Registration in Singapore.
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