PUTRAJAYA, June 3 — The Medical Device Authority (MDA) has confirmed that the 17 types of medical devices sold online, which previously failed safety tests, are now safe for use by the public.
MDA chief executive Dr Muralitharan Paramasua said that based on a review of the investigation report and re-testing submitted, it has found that all the medical devices now meet the standards and are safe and effective for continued use by the public.
The affected devices are Dynmed brand oxygen concentrators; Angel Biss (SH01) and Carer; blood pressure monitors (BPLife, Novoplus, Yuwell and Ouson+); glucose meters (Roche, Sinocare and Yasee); thermometers (BioCare, Scaneo and Ouson+) as well as surgical and examination gloves (Gammex, Shirudo, Puritex and Infinity Latex).
Dr Muralitharan said that thorough investigations and corrective actions had been carried out by all the establishments (companies) following the February 15 MDA report regarding the devices’ failure to comply with standards.
“All the establishments involved showed a high commitment to undergoing full investigations. This is in line with the post-market responsibilities outlined in the Medical Device Act 2012 (Act 737),” he said in a statement today.
Dr Muralitharan said comprehensive actions, such as the improvements in quality control systems, compliance with regulation guidelines as well as increased transparency in managing safety and efficacy issues of the devices had helped restore public confidence.
He also advised the public to be more cautious when purchasing medical devices online.
“The public needs to ensure the medical devices bought are registered with the MDA and sold by licensed establishments,” he said.
Further information and complaint channels can be accessed via official MDA website at www.mda.gov.my or by contacting 03-82300300. — Bernama
