Seven companies had their licenses revoked for selling unregistered medical devices, says MDA

PUTRAJAYA: The Medical Devices Authority (MDA) has seized various unregistered medical devices this year, including blood pressure monitors, condoms, digital thermometers, and medical test-kits. These seized items, valued at around RM500,000, were confiscated in five raids conducted nationwide, according to Dr Muralitharan Paramasua, the CEO of MDA. He further stated that as of September 6th, a total of seven companies have had their licenses revoked for selling unregistered medical devices. These companies will also face charges under the Medical Device Act (Act 737), which mandates the registration of all medical devices manufactured, imported, or distributed in Malaysia. Dr Muralitharan made these remarks after the signing ceremony between MDA and the Malaysian Administrative Modernisation and Management Planning Unit (Mampu) on September 6th.

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Regarding the upgrade of the Health Ministry’s Medical Device Centralised Online Application System (MeDC@St), Dr Muralitharan explained that it will enhance monitoring of medical devices and products’ sales and registration in the country. He added that every medical device in the local market must be registered with MDA. The system’s enhancement will help combat the sale of counterfeit and unlicensed medical devices, as it currently contains data of all registered medical device suppliers. Additionally, the registration process for suppliers will be streamlined and expedited with the system’s improvement. Previously, it could take between 30 to 90 days for an application to be approved, depending on the device category.

MeDC@St is an online platform that allows companies and the public to register devices, apply for permits, and provide feedback on medical devices in the country.