BY 2010, all medical devices - from high-risk stents for heart surgery to low-risk ones like mechanical wheelchairs - will be licensed, promising consumers a minimum standard of quality.

The move to regulate medical devices is expected to cost the Health Ministry about $10 million a year over the next five years, primarily to recruit more people to enforce the new rules.

But Dr John Lim, head of the Health Sciences Authority (HSA), said at a media briefing on Thursday: 'It will hopefully be a non-event for consumers.'

This move comes after the Health Products Act was passed earlier this year to consolidate the various medical-related Acts.

The Act allows flexibility in implementation of controls for different products, which have grown in diversity and complexity.

Since the rules serve more as a precaution, Dr Lim said the rollout will be gradual to reduce inconvenience to manufacturers and importers.

Medical devices are defined as products used to diagnose, prevent, treat, monitor or alleviate a medical condition in humans. Not on the list are things like exercise equipment, magnetic accessories or aromatherapy products.

Devices have been grouped into four classes, based on their level of risk. The first to be regulated will be the high- to medium-risk items like artificial heart valves and CT scanners.

More than 4,000 of these - used mainly in hospitals and by doctors - are already registered under the voluntary registration scheme.

The HSA is also looking at which low-risk devices, such as bandaids and walking sticks, can be exempted from registration.

Dr Lim said that Singapore's requirements will be in line with the accepted global ones, and no labelling will be required as everything sold here by 2010 will have to conform to HSA standards.

Medical devices are the first area of health products to be regulated. It will be followed soon by cosmetics, in line with a move by other Asean nations to do so.

Other areas that may be included in future include health supplements.

The new Act also gives HSA powers of enforcement, which it lacked in the past, like requiring companies to recall products, for example.

Anyone who contravenes the Act can be fined up to $10,000 or jailed for up to six months, or both.