HSA Singapore Medical Device Regulations
The Health Sciences Authority (HSA) oversees the regulations of medical devices sold in Singapore.
Singapore medical device regulatory framework
Singapore’s Health Sciences Authority (HSA) oversees the system of statutory control aimed to safeguard the quality, safety, and efficacy of medical devices available in Singapore. Almost all medical devices are regulated. Only Class A medical devices supplied in a non-sterile state are exempt. Class B, C, and D medical devices are subject to product registration requirements.
Key medical device regulations in Singapore include:
- Health Products Act 2007
- Health Products (Medical Devices) Regulations 2010
- No. S 334/2016 Health Products (Medical Devices) Regulation
Singapore is one of the original member states of the Association of Southeast Asian Nations (ASEAN). Therefore its regulatory scheme is informed by the ASEAN Medical Device Directive.
Singapore medical device registration pathways
To sell a medical device in Singapore, you must register your device with the HSA and obtain a dealer’s license. Class A devices are exempt from registration but must still obtain a dealer’s license. You can check HSA’s Class A Exemption List to confirm your device’s exemption status.
Registration requirements for Class B, C and D devices vary for each risk class tier and registration route. Your device may require a full evaluation if you do not have market authorization in any other markets. If your device has approvals from USA, Canada, the EU, Australia, and Japan, you may be eligible for an immediate, abridged, even expedited registration route depending on its classification.
Some Class C and D devices are not eligible for expedited routes regardless of their registration history, such as active implantable devices, certain high-risk IVD assays, certain joint replacements, etc.
Helpful resources for Singapore HSA medical device registration
As you begin planning to market your device in Singapore, here are some resources that will be useful along the way:
- Health Sciences Authority (HSA)
- HSA guidance documents for medical devices
- Medical device classification tool
- ASEAN
- ASEAN Medical Device Directive
Frequently
Asked Questions
Do foreign manufacturers require in-country representation in Singapore?
Yes, foreign manufacturers must appoint a Singapore Registrant if they have no legal entity in Singapore. However, manufacturers of Class A exempt devices do not require a Singapore Registrant.
How long does it take to obtain HSA registration for a medical device?
Registration timelines for Class B, C, and D in Singapore can vary considerably based on the device’s classification and the registration route. On the low end, registration review can take 100 working days. On the high end, it can take longer than 300 working days.
How long are medical device registrations valid in Singapore?
Dealer’s licenses must be renewed annually, beginning 12 months from the issue date of the license. Registrations do not expire as long as annual fees are paid and post-market surveillance requirements are met. You must also officially notify HSA of any relevant changes to your device before they are implemented.
