EMERGO SUMMARY OF KEY POINTS

• Singapore’s Health Sciences Authority (HSA) has launched a priority review scheme for qualifying medium- to high-risk medical devices.
• The new registration route provides faster Singapore market access for devices that address key HSA healthcare areas; are novel; or that target unmet clinical needs.
• Class A devices as well as some combination products do not qualify for the new registration route.

Singaporean medical device regulators have implemented a new priority market pathway that could reduce review timeframes for qualifying medical devices by up to 35% within two years.

The new Health Sciences Authority’s (HSA) priority review scheme (see slide 27), launched on August 1, 2017, is open to medical devices that fall under a “Full evaluation” route (Route 1) and devices that qualify for both of the two criteria below (Route 2):

• Criteria 1- The device targets one of HSA's five focus areas: diabetes, cancer, ophthalmic diseases, cardiovascular diseases or infectious diseases
• Criteria 2 - The device is designed and validated to address an unmet clinical need, or utilizes a novel or breakthrough technology

Class B, C and D devices may qualify for the HSA priority review scheme; Class A devices and combination medical devices with medicinal components are not eligible.

Timeframes and fees

HSA anticipates that the priority review scheme will reduce turnaround times for premarket reviews for the full evaluation routes by 25% by mid-2018, and by 35% by late 2019. Evaluation fees for the HSA priority review scheme are set to increase 15% over current rates for route 1, while fees for full HSA reviews route 2 will increase 50% over existing rates.

How the HSA priority review scheme works

Medical device manufacturers interested in HSA registration via priority review must provide submit the same application materials and documentation as companies using the standard Singapore market registration route. In addition, manufacturers must provide justifications showing how their devices meet criteria to qualify for priority review. All registration materials should be submitted via HSA's Medical Device Information and Communication System (MEDICS) online submission portal.

HSA staff will then assess priority review applications and either approve them or request additional information (via Input Request, or IR). An applicant that receives an IR will strictly have two weeks to respond; inadequate responses will result in the applicant being switched to the full HSA premarket review route.

According to Perle Reyes, Emergo Regulatory Affairs Specialist in Singapore, the priority review scheme provides an opportunity for faster evaluation times for medical devices that would otherwise fall under the HSA's full evaluation route. “These are the devices that have not been registered in any of the GHTF reference countries,” Reyes explains.

“Likewise the scheme recognizes the relevance of devices that fall under criteria 1 and 2 to the requirements of health facilities and consumers in Singapore,” she says.

Additional Emergo resources for Singapore:

• Singapore HSA medical device registration consulting
• Singapore Registrant in-country representation
• Whitepaper: Medical device registration in Singapore
• Video overview of Singapore’s medical device regulatory process