Protection against 'fly by night' devices

PUTRAJAYA - The Medical Device Act to be implemented in October will protect Malaysians from medical devices that could jeopardise their health, said Health Minister Datuk Seri Liow Tiong Lai (pictured).

The act, which was gazetted in March, will ensure devices sold in Malaysia adhere to the country's standards.

He said manufacturers, importers, distributors and local authorised representatives would be required to register the devices with the Medical Devices Authority, which was set to function next month.

"It's akin to medicine being registered with pharmacies. The devices will be sold under strict conditions to ensure it won't affect people's health. This is good for the country and investors will have a lot of confidence here as their products will not face copyright issues because their patented products will be protected," he said after chairing the fifth Healthcare National Key Economic Area post steering committee, here, yesterday.

Liow said manufacturers, importers, distributors and local authorised representatives would be given a two-year grace period to register their products. Should they continue to sell unregistered products when the ruling is enforced in 2014, they can be slapped with a maximum fine of RM200,000.

Medical devices will be categorise into four groups namely, low risk, medium risk, high-medium risk and high risk. Low risk includes items such as bandages and stethoscopes, while condoms and gloves fall under medium risk. High-medium risk items comprises cat scan and Magnetic resonance imaging machines, while pace makers would be high risk devices.

He added that there were many products that claim which could cure various illness and the act would also go after these items.

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