The Health Sciences Authority (HSA), Singapore’s medical device regulator, has published draft guidance on new expedited and immediate evaluation routes for Class B low-risk devices.
As previously reported by Emergo Group, Singapore implemented changes to its medical device regulatory framework effective April 20, 2012, offering easier paths to market for qualifying Class B products. HSA has established an expedited Class B Registration (EBR) evaluation route, as well as an immediate Class B Registration (IBR) evaluation route for certain Class B medical devices; new guidance provides further details on how to qualify for these routes.
According to the HSA guidance, EBR qualifications include the following:
- Device must have prior approval from at least one of HSA’s independent reference agencies, including the US FDA, Australian TGA, Japan’s MHLW, Health Canada and EU Notified Bodies
- Device must have been marketed for at least three years in at least one of the markets listed above
- Device should have no safety issues—specifically deaths or serious health “deteriorations.”
- There should be no open field safety corrective actions or recalls associated with your device at the time of your submission to HSA.
Medical devices that have registered with at least two HSA reference agencies for uses similar or identical to those intended for Singapore also qualify for EBR.
EBR submission requirements for Class B devices approved in only one reference market include proof of marketing history as well as a declaration that no global safety issues exist for a device. EBR submission requirements for devices already approved in two or more reference markets do not have to supply this information.
Devices eligible for the IBR registration route in Singapore must meet the following criteria:
- Device must be registered with at least two reference agencies
- Device must have been marketed for at least three years in both reference agency jurisdictions
- There should be no global safety issues (deaths or serious health deteriorations) within the last three years
- There should be no open field safety corrective actions or recalls for the device
- Device should have no record of rejection or withdrawal from any reference agency
Upon successful HSA review, IBR devices are granted immediate market access in Singapore.