SINGAPORE - Starting this month, the fees for medical devices brought under the Special Authorisation Routes (SAR) are to be lowered to make it more affordable for Small and Medium Enterprises (SME) to import low cost and low volume medical devices.
The SAR allows licensed importers and healthcare professionals to import unregistered medical devices for unmet medical needs due to lack of registered alternatives, for re-exportation purposes, and for non-clinical purposes like research and training.
Previously, the fees were set at $500. Under the new structure, the fees now range between $150 to $350.
This is part of the Health Sciences Authority's (HSA) enhancements to the medical device regulatory framework announced earlier this year to expedite access and manage regulatory costs for medical devices.
It was in response to feedback received from the healthcare industry, particularly SMEs, that the current application fees charged for some products are high in comparison to the cost and volume of the products imported.
Hence, as part of HSA's review, a survey was sent to all doctors, dentists and importers on the specific low cost and low volume medical devices that they use or import, including the cost and annual volume of the items.
To ensure that the fee revision will not be inappropriately used to by-pass registration of medical devices, HSA will be refining the application criteria for devices eligible for the SAR routes following further consultations with industry professionals.
This too will enhance the consistency and clarity of the SAR application system, HSA said.
The move was commended by the Association of Medical Device Industry (Singapore) and the Singapore Manufacturers' Federation (SMa), both of which applauded HSA's positive response to feedback received and said they will be working closely with HSA in the upcoming review of the medical device framework.