Medical devices
HSA regulates the import, manufacture, export and supply of medical devices in Singapore to safeguard public health and safety.
New tool available: Try our AI-enabled risk classification tool (beta) to obtain an estimated risk classification of your medical device.
Regulatory overview
Understand the scope of regulations on medical devices in Singapore.
Digital Health
Understanding digital health products and the regulations.
Registration of medical devices
Understand the process of medical devices registration
Manufacturing, import and supply
You need a dealer's licence if you import, wholesale and manufacture medical devices in Singapore.
Advertisement, post-market surveillance and safety monitoring
Find out the requirements related to advertisement, post-market surveillance and safety monitoring.
Innovation Office (Medical Devices)
Find out more on HSA’s initiatives in supporting innovation for Singapore’s MedTech industry.
Tools and resources
View the list of tools and resources for medical devices registration
Guidance documents for medical devices
Here is the list of guidance documents with relevant forms and templates to help you meet the regulatory requirements for dealing in medical devices.
Fees and turnaround time for medical devices
Here is the list of fees and turnaround times to help you with your medical device transactions.
