Medical items to be registered

New ruling beginning November applies to bandages, condoms and other devices

PUTRAJAYA: Come November, all medical items – from the easily obtainable bandages, condoms and syringes to the sophisticated magnetic resonance imaging equipment – must be registered with the authorities.

This, said Health Minister Datuk Seri Liow Tiong Lai, was to protect consumers from low-quality products that could pose health risks.

Even beauty products such as facial fillers and breast implants, as well as slimming or weight reduction equipment used in beauty salons, are also required to be registered.

“Weare setting a Malaysian standard and once the new regulation is implemented, many of the low-quality products, including those from China, will not be allowed to be used here,” he said at a press conference here yesterday.

Liow said the manufacturers and importers should register the products before these were sent to Malaysia.

He explained that the medical devices had been divided into four risk categories – low, medium, high to medium and high.

He said those in the low-risk category included bandages and stethoscopes while items such as condoms and syringes had been categorised as medium-risk.

Equipment such as the MRI and CT scanners have been placed under the high to medium-category while implants and needles for syringes have been placed in the high-risk category.

The responsibility of registering the items, however, was with the manufacturers, distributors, importers and local authorised representatives.

The new ruling follows the implementation of the Medical Device Act 2011.

Liow said registration should be done with the Medical Devices Authority (MDA) that was set to function next month.

“Those found guilty of failing to do so will face a maximum fine of RM200,000,” he warned.