Check on medical devices to ensure they are safe for public use

PUTRAJAYA (May 21, 2012): Manufacturers and importers of medical devices will soon come under the microscope as the Health Ministry moves to regulate the industry.

Under the recently gazetted Medical Device Act 2011, a Medical Devices Authority will be formed as a regulatory body to register such devices, and to monitor manufacturers and importers for quality compliance.

More than 3,000 items, including everything from thermometers, condoms, pacemakers and Magnetic Resonance Imaging (MRI) machines are expected to come under scrutiny under this Act.

Health Minister Datuk Seri Liow Tiong Lai told a press conference yesterday the Medical Devices

Authority is being set up to ensure that medical devices used by hospitals, clinics, individuals or sold by pharmacies are safe for public use.

“The authority will be set up by the end of May, and a board of directors, chaired by the health director-general, will also be established. The board is expected to conduct its first meeting by June,” Liow said.

Over the next few months, the authority will draw up subsidiary regulations in the Act.

“The regulations are scheduled to be drawn up by end-October, after which the authority will begin the registration process over a period of two years.

“Devices which fall under the medium-high or high-risk categories (see accompanying graphic) will have to register with the authority, who will ensure that the products adhere to strict standards.

“This way, we will no longer allow fly-by-night or sub-standard manufacturers to put their products on the market,” Liow said.

The minister was speaking after a National Key Economic Area (NKEA) for healthcare steering committee meeting at the ministry yesterday.

Makers or importers who refuse to register after the two-year period is over will face a maximum penalty of RM200,000 fine or three years imprisonment, or both.

Liow said devices that are marketed with false claims on medical efficacy will also be pulled off the shelves.

“If a device is claimed to treat diabetes or high-blood pressure without proper clinical proof, they will not be allowed to register with the authority (and hence won’t be allowed for sale),” he said.

Medical devices are defined under the Act as any instrument, implant, in-vitro reagent or calibrator, software, or material intended by the manufacturer to be used, alone or in combination, for the purpose of:

>> diagnosis, prevention, monitoring, treatment of disease or injury.
>> of investigation, replacement or modification or support of the anatomy or a physiological process
>> disinfection of a medical device
>> control of conception
>> or support or sustainment of life.

Pills, drugs, serums or vaccines are not considered medical devices.

Liow, however, said that retailers of medical devices or individual users do not need to register with the authority.

When approached after the press conference, Health Ministry Medical Device Control Division director Zamane Abdul Rahman said a website is being developed for manufacturers to register their devices online, as well as for users and retailers to check for devices which are blacklisted or not registered to the authority.
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