Singapore’s New Device Regulatory Framework

Ames Gross

The Singapore Health Sciences Authority (HSA) passed the Health Products Act in February 2007 to improve the regulatory control of medical devices in Singapore. This was a fundamental change in the regulation of medical devices. Previously, medical device regulations were relatively lax in Singapore.

To minimize disruption to supply and to ease transition into the new regulations, the Health Products Act was implemented in phases throughout the past few years. As of January 1, 2012, all phases of the Act have been executed.

The Health Products Act requires all medical devices Class A-D to be registered with HSA prior to being placed on the Singapore market. Also, all manufacturers, importers, and wholesalers of medical devices are required to have government licensing (dealer’s licenses) before doing business in Singapore.

Now that the new medical device regulations in the Act are put into practice, the Singapore HSA may continue to amend the regulations according to industry feedback. Medical device companies are advised to check regularly for new medical device updates in Singapore that may affect the regulation of their products and their legal compliance.

Ames Gross, president and founder of Pacific Bridge Medical (PBM), is recognized nationally and internationally as a leader in the Asian medical markets. In 2008, MD&DI (Medical Device & Diagnostic Industry) magazine named Gross one of the top 100 executives in the medical business. Gross founded PBM in 1988 and has helped hundreds of medical companies with business development and regulatory issues in Asia. Gross holds a BA, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.