By Stewart Eisenhart, Emergo Group
In a move likely to boost interest in the Singaporean medical device market, the Health Sciences Authority (HSA), Singapore’s medical device market regulator, plans to implement new rules effective May 1 to provide expedited market access for lower-risk devices.
First, the rules will exempt all Class A medical devices (with the exception of sterile Class A products) from HSA registration requirements.
Manufacturers of qualifying devices must still declare their products in their importer and manufacturer licenses, and update their lists of qualifying devices every six months to enable post-market surveillance efforts. Sterile Class A device registrations will have target timelines of 30 days, and fees for these registrations will remain at $25. The HSA estimates that 80% of all Class A devices will qualify for the new registration exemption.
Effective September 1, 2012, the HSA will also establish Immediate and Expedited Registration routes for some Class B devices.
- Immediate Registration Route: allows immediate access to the Singaporean market for Class B devices already approved by at least two independent reference regulatory agencies (US FDA, EU, Health Canada, Therapeutic Goods Administration and/or Japan’s MHLW) and marketed for at least three years with no safety issues
- Expedited Registration Route: 60-day registration periods will be available for Class B devices that have either been approved by at least two independent reference regulatory agencies or approved by one such agency and have been marketed either in Singapore or that agency’s jurisdiction for three years without any safety issues
Second, Singaporean regulators plan to implement a lower-tiered fee structure for Special Authorization Route (SAR) devices starting August 1, 2012. The SAR is designed for innovative, low-cost and low-volume devices. The HSA will temporarily offset SAR fees for all applicants subject to pending registration or change notification that have submitted their applications by December 31, 2012. In addition, eligible SAR applications that have not been approved by the HSA as of April 20, 2012 will be issued refunds.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.