Singapore: Lower-Risk Medical Devices Subject to More Favorable Regulations

Singapore’s Health Sciences Authority (HSA) classifies medical devices into 4 classes according to its intended use and the risks associated with its use. The HSA passed a number of medical device regulatory changes to facilitate the market entry of lower-risk Class A and B medical devices (which comprise nearly 70% of all medical device applications in Singapore). These regulatory changes will grant faster access to low-risk medical devices without compromising public safety.

Currently, all Class A medical devices—medical products with the lowest risks—are subject to mandatory registration before being imported and used in the Singaporean market. Starting May 2012, only sterile Class A medical devices will be subject to mandatory product registration. The approval processing time will be reduced to 30 working days. All non-sterile Class A medical devices will be exempt from the $25 product registration fee. However, manufacturers and importers will be required to declare the Class A medical devices in their licenses to enable post-market surveillance and monitoring.

The HSA also introduced accelerated product registration routes for Class B medical devices to be in effect September 2012. Products that have already been approved by at least two key international regulatory agencies— the US FDA, EU Notified Bodies, Australia’s TGA, Health Canada, and Japan’s MHLW—and marketed for at least 3 years without safety issues will be granted immediate product registration approval.

Medical devices that have either (1) been approved by at least two of the international reference regulatory agencies, or (2) been approved by one international regulatory agency and marketed for a minimum of three years without safety concerns, will be granted an expedited 60-day product registration route. Product registration fees for both immediate and expedited routes will be reduced from the current $2,300 to $1,400.

Other regulatory changes enacted by the HSA include a lower-tiered fee framework for innovative low-cost and low-volume medical devices qualified for the GN-27 Special Authorization Route (SAR). Starting August 2012, approved SAR product applications will be subject to lower fees as well as a longer, one-year validity.