CYBERJAYA, Nov 12 (Bernama) — The Medical Device Authority (MDA) has flagged the sale of unregistered medical devices by companies operating without proper licences through online platforms.
In a statement today, the authority said most sellers operate without verifiable identities or physical addresses and make exaggerated or questionable health claims to attract buyers.
MDA warned that purchasing and using unregistered medical devices could compromise public safety and pose health risks, as such products do not meet the safety, quality, and efficacy standards mandated by the authority.
“MDA does not encourage the purchase of medical devices through any e-commerce platform as doing so may result in the acquisition and use of counterfeit, unregistered, or potentially dangerous products.
“We urge the public to remain vigilant and ensure that any medical device they purchase is registered with MDA and sourced from companies holding a valid licence under the Medical Device Act 2012 (Act 737),” the authority said.
MDA also reminded e-commerce platform operators of their responsibility to ensure that all medical devices advertised or sold on their platforms are registered and sourced from licensed companies under Act 737.
The authority stressed that any company or individual found selling, distributing, or marketing unregistered medical devices will face strict legal action, including fines, product recalls, and prosecution.
Members of the public are advised not to base purchases solely on price, as low-cost devices may appear attractive but may not meet the essential standards of registration, quality, and effectiveness – critical considerations given the role of these devices in patient care.
Using unregistered or low-quality devices may lead to serious health risks, including device malfunction, unintended side effects and treatment complications.
To facilitate safe purchases, MDA requires that all advertisements for registered medical devices include the registration number and a statement confirming registration under Act 737.
The public is encouraged to verify device registration and distributor licences via MDA’s official portal at https://mdar.mda.gov.my, and to submit complaints through the FEMES (Feedback Management System) platform at https://femes.mda.gov.my.
— BERNAMA