Addressing the rising concern that some medical devices designed for use by medical professionals are being advertised and distributed on the open market, Malaysian health authorities are tightening regulations on the unauthorized sale of such devices.
In a public notice published in May, the Medical Device Authority warned that IVD test kits and other medical devices intended to be employed by medical professionals present serious risks when employed by laypeople. Anyone found to be distributing such devices to the public faces significant fines, and the loss of registration of the medical device.