Medical Device Registration in Singapore

The medical device market in Singapore is about $500 million. While Singapore now has a voluntary regulatory environment, new regulations being implemented will require product registration for all medical devices by 2011.

Singapore's chief medical regulatory body is the Health Sciences Authority (HSA). In 2007, the HSA passed the Health Products Act, allowing them to conduct mandatory product registration and regulate the supply, distribution, manufacturing, import, and advertisement of all health products. Registered medical devices are listed on the Singapore Medical Device Register (SMDR), which is publicly available on the HSA's website.

Before a device dossier or product registration application is submitted, the HSA must initially verify that the product qualifies as a medical device under the Health Products Act. Once it is confirmed to be a medical device, the application process can begin. There are four types of medical classes: A, B, C, and D. Class A devices are lower risk while Class D devices are higher risk medical products.

For more information on medical device registration in Singapore, please see the following PBM publications and/or contact us to discuss your specific needs.