Singapore Decreases Medical Device Approval Time

The Health Sciences Authority (HSA), the regulatory body in charge of medical devices in Singapore, announced a dramatic change in its approval process of devices entering the country. In response to complaints from doctors and patients about the high costs and long waiting periods for approval, the HSA initiated a proposal for cutting approval times and registration costs of two low-risk medical device categories, Classes A and B. The proposed changes will take effect beginning May 1.

At the start of this year, new rules took effect requiring all medical devices entering the country to be registered with the HSA. Devices were categorized into risk classes A, B, C and D, with D being the highest risk. According to the HSA, Class A and B devices account for about 70 percent of all medical device applications it receives, so the new procedures should help a majority of those waiting for devices.

Beginning May 1, the HSA will exempt non-sterile Class A devices from registration. Only 20 percent of Class A devices qualify as sterile. There will also be no registration fee for any Class A device. Class B devices will fall into one of two categories: Immediate registration or expedited registration, depending on if the device has been registered with the HSA’s independent regulatory reference agencies. If the device qualifies for expedited registration, the approval time will be reduced from 100 to 60 days. Class B registration fees will be reduced from $1,845 (U.S.) to $1,123.

Class A devices include products such as surgical face masks and wheelchairs, while Class D includes products which come into contact with vital organs, such as heart valves and neural stents.