PUTRAJAYA, Sept 6 — The business licences of seven companies selling, manufacturing and distributing unregistered medical devices in the country have been cancelled so far this year, said Medical Device Authority (MDA) chief executive Dr P. Muralitharan.
He said the business licences were revoked between January and August this year under the Medical Device Act 2012 (Act 737), involving confiscating devices worth about RM500,000.
“Among the devices seized were digital thermometers, blood pressure monitors, test kits and condoms,” Dr Muralitharan said.
He was speaking to the press after attending the signing ceremony of the Medical Device Centralised Online Application System (MeDC@aSt 3.0) development consultation service between MDA and the Malaysian Administrative Modernisation and Management Planning Unit (MAMPU), earlier today.
Dr Muralitharan said these companies will also be charged in court for selling and distributing illegal medical devices that did not have the authorities’ approval and could be harmful to consumers.
The MDA is a statutory body under the Health Ministry which controls and regulates medical devices and the industry.
It is responsible for managing registrations, applications for sales licences and evaluating medical device products before they are certified safe for use in health facilities or for sale to consumers.
— Bernama
