SINGAPORE: Medical devices such as blood pressure monitors and hearing aids brought in under the Special Authorisation Routes (SAR) will now cost less.
The Health Sciences Authority (HSA) has lowered the fees for bringing in the devices for patients — by between S$150 and S$350.
Previously, the fees were set at S$500.
Under SAR, licensed importers and health—care professionals can import unregistered medical devices where there is a lack of registered alternatives.
The biggest cut is for requests by healthcare practitioners to import unregistered medical devices for use in specific—named patients — from the previous S$500 to the current S$150.
For requests by licensed importers to import unregistered medical devices for use in specific institutions, the fee is now S$350, instead of the previous S$500.
Importers can also bring in and re—export such devices, or import them for research and training. The fees have been halved — from S$500 to S$250.
The HSA said on Thursday that the revised fees took effect on August 1.
They are part of changes to the medical device regulatory framework announced earlier in 2012 to reduce the need to register low—cost and low—volume devices. This will translate to quicker access to the devices, as well as a more effective way to manage regulatory costs.
The HSA said it arrived at the costing after consulting healthcare professionals and the medical device industry, particularly small and medium enterprises.
Dr Raymond Chua, group director of HSA’s Health Products Regulation Group, said: "Taking into account concerns expressed about access and cost issues and to ensure that medical devices continue to be optimally available for patient care, HSA has further streamlined processes for reviewing and approving SAR applications. This is reflected in the lower SAR application fees that we are implementing."
President of the Association of Medical Device Industry (Singapore), Mr Henry Tan, added: "AMDI welcomes the revision of the fees for the Special Authorisation Routes by HSA to make it more affordable for SME. It clearly shows that HSA listens and understands the industry. AMDI will continue to work with HSA to review on the medical device framework."
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