Faster, lower-cost registration of medical devices: HSA

New rules that came into effect in the beginning of this year required that medical devices brought into Singapore be registered with the Health Sciences Authority (HSA).

Doctors and importers, however, complained about the registration fees, processes and long waiting times for approval, even for products that have been in the country for a long time.

Moving to address complaints by the medical industry here, HSA yesterday announced changes to quicken the registration process for medical devices while lowering registration costs.

There are four categories in total, with Class A being the lowest risk and Class D being the highest risk.

Examples of Class A devices are surgical face masks and wheelchairs, while Class D devices include products that come into contact with vital organs, such as heart valves.

The HSA announced yesterday it would cut approval times and registration costs for two low-risk categories of medical devices - Class A and B - from May 1 and Sept 1 respectively.

More Class A devices - from 2,000 to 4,700 devices, or 80 per cent of all Class A devices - will be exempted from registration.

Going forward, the HSA is looking at changes for Class C and D devices.

In a press briefing yesterday, HSA chief executive Dr John Lim said these changes were based on industry feedback.

He said: "Key concerns that came through these sessions were the longer than expected timelines ... high registration costs, especially for certain niche devices and, in particular, those that are low cost, low volume."

"Then there was the question (of) whether the HSA really needs to evaluate devices already approved by reputable agencies such as the United States FDA (Food and Drug Administration) and EU (European Union)," said Dr Lim.

Doctors contacted were encouraged by the news and said less costs would be passed on to patients. Yet, they wanted more to be done to lessen the number of applications to the HSA and to streamline the processes.

Also, many doctors feel the Government should pay the costs of regulation, as it will otherwise be passed on to patients, he added. 

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