The Health Sciences Authority (HSA), Singapore’s medical device regulator, has published draft guidance on new expedited and immediate evaluation routes for Class B low-risk devices.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:
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:
Upon successful HSA review, IBR devices are granted immediate market access in Singapore.