Regulatory overview of medical devices

Understand the scope of regulations on medical devices in Singapore.

Legislation

We regulate medical devices in Singapore under the Health Products Act (HPA) and its Health Products (Medical Devices) Regulations 2010.

Scope of regulation

We require companies to obtain a dealer's licence before manufacturing, importing or supplying medical devices. All medical devices will require registration with us before they can be supplied in Singapore, except for Class A low risk medical devices, which are exempted from product registration, or under specific conditions as approved by us.

Device registration

You must register your medical device before you can supply it in Singapore. Registration requirements will differ depending on your device's risk classification and the evaluation routes.

Dealer's licensing

All medical device dealers will need to apply for a dealer's licence before you can import, manufacture and supply your devices in Singapore. HSA will assess if you meet Good Distribution Practice requirements before issuing your licence.

Notify changes for registered devices

You must notify HSA prior to implementing changes to your medical device. The changes include technical changes, review changes, administrative changes, notification changes and changes arising from Field Safety Corrective Actions.

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Adverse Events (AE) reporting

Field Safety Corrective Actions (FSCA) reporting

If your device poses a health risk to users, you must inform HSA, take corrective actions, and send out communications to the device users, healthcare professionals and the public.