Understand the scope of regulations on medical devices in Singapore.
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.