The Health Sciences Authority (HSA), the agency regulating the medical device market in Singapore, has lowered registration fees for its Special Authorization Routes (SAR) to expand public access to low-risk devices.
The SAR program enables importation of unregistered medical devices into Singapore in cases where no alternative registered products are yet available in the country. Importers may also utilize SAR in order to import and then re-export devices, or import for non-clinical research and training purposes.
As of August 1, 2012, fees for the five Special Authorization Routes available from HSA will be reduced:
- GN-26 (requests from healthcare providers to import unregistered devices to treat specific patients): from $500 to $150
- GN-27 (requests from licensed importers to import unregistered devices for use in specific public hospitals or clinics): from $500 to $350
- GN-28 (requests from importers to import unregistered devices in order to re-export them from Singapore): from $500 to $250
- GN-29 (requests from importers to import unregistered devices for non-clinical applications): from $500 to $250
(All figures are in Singaporean dollars.)
The revised SAR fee structures are part of HSA's broader effort to streamline registration processes for medical devices in Singapore. Interest among medical device manufacturers in Singapore’s market was already increasing, but this further easing of regulatory requirements will further drive up registrations among foreign firms with the HSA.