MDA Acts On Over 300 Medical Device Complaints In 2025

By Samantha Tan Chiew Tieng

PUTRAJAYA, April 13 (Bernama) -- The Medical Device Authority (MDA) received more than 300 complaints related to medical devices in 2025, all of which were investigated and followed by enforcement or legal actions against companies found to have breached regulations.

MDA chief executive Dr Muralitharan Paramasua said that by the end of the year, approximately 10 companies were convicted for offences such as selling unregistered devices or operating without valid licences.

“The rest involved licence suspensions or revocations. These were among the enforcement measures we are intensifying,” he told Bernama after the MDA Excellent Service Awards 2025 today.

Dr Muralitharan said among the most frequently reported products were contact lenses, thermometers, blood pressure monitors, catheters and syringes, particularly consumable items.

He stressed that all medical devices marketed in Malaysia must undergo stringent evaluation and verification by the MDA to ensure their safety, especially for patient use.

Meanwhile, Dr Muralitharan said that the authority is also paying close attention to online sales channels, which have emerged as a key avenue for the distribution of unregistered products.

“MDA will continue to intensify monitoring and enforcement against any party selling unregistered medical devices or operating without a valid licence, to ensure consumer safety is protected at all times,” he said.

He also encouraged the public to report any suspicious sales activities involving medical devices as part of a collective effort to safeguard public health.

At the event, Dr Muralitharan also expressed appreciation to the media for helping raise awareness of MDA’s role and the importance of medical device registration.

“The media plays a crucial role, as their coverage has helped the public better understand that all medical devices must be registered and purchased from authorised representatives,” he said.

-- BERNAMA