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.
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.
Register your device
Changes to registered devices
Free Sales Certificate and Export Certificate
Report adverse events
Field Safety Corrective Action reporting
Advertisements and promotions
Bringing personal medical devices into Singapore
COVID-19: Standards Resources for Essential Medical Devices
Standards for Medical Devices
Fees and turnaround time
Registration and licensing tools