HSA revises rules for registration of devices

The Health Sciences Authority (HSA) has announced that it will be making radical changes to the registration of medical devices here.

This follows a flood of feedback from doctors and importers about new rules for registration.

The rules, which came into effect earlier this year, required the industry to register all medical devices brought into the country.

Doctors and importers had been vocal in their complaints about long approval times and other difficulties they faced with the new rules, which they claimed would push up health-care costs and reduce the number of devices in use here.

But with the changes announced yesterday, it will become easier, faster and sometimes cheaper for importers to register medical devices.

HSA's chief executive officer, Associated Professor John Lim (left), said the aim is to "maintain patient safety while better meeting stakeholder needs".

All low-risk Class A devices - except for sterile devices - will now be exempt from registration.

This change will affect 4,700 items including wheelchairs and hospital beds.

Class B products such as catheters and hypodermic needles, which are low to medium risk, will be divided into three groups, depending on whether they have been registered and used elsewhere.

There are four classes, with D for devices that involve the highest risk. These include products that come into contact with vital organs, such as heart valves and stents.

This article was first published in The New Paper.