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:
