PUTRAJAYA – There’s some good news for consumers who rely on home medical equipment. The Medical Device Authority (MDA) has confirmed that 17 types of medical devices that had previously failed safety tests are now safe for public use.
MDA Chief Executive Officer, Dr. Muralitharan Paramasua, said the decision comes after a thorough re-evaluation of investigation reports and re-testing data submitted by the manufacturers. “We’ve reviewed the latest test results, and we’re confident these devices now meet all necessary safety and performance standards,” he explained in a statement on Tuesday (June 3).
The devices in question include popular brands of oxygen concentrators such as Dynmed, blood pressure monitors from BPLife, Novoplus, Yuwell, and Ouson+, glucose meters from Roche, Sinocare, and Yasee, thermometers by BioCare, Scaneo, and Ouson+, and surgical and examination gloves under brands like Gammex, Shirudo, Puritex, and Infinity Latex.
This assurance comes after a February 15 report revealed these products had initially failed to comply with national safety requirements. Since then, manufacturers have taken full responsibility, conducting internal investigations and making significant improvements to ensure quality and compliance.
“All the companies involved have shown a strong commitment to fixing the issues. They’ve upgraded their quality control systems and aligned more closely with regulatory guidelines. This shows serious dedication to public safety,” Dr. Muralitharan noted.
He also urged Malaysians to remain vigilant when purchasing medical devices online. “Always check that the device is registered with the MDA and that it’s sold through licensed channels,” he advised.
For those looking for more details or wishing to report concerns, you can visit the MDA website at www.mda.gov.my or contact them directly at 03-8230 0300.
