from the Star: Medical tools to be registered within two years
All medical devices will need to be registered with the Health Ministry within two years in line with the Medical Device Regulations 2012.
The move, effective yesterday, is meant to ensure all medical devices in the country are in compliance with safety and performance re-quirements as stipulated under the Medical Device Act 2012 (Act 737), said Health director-general Datuk Dr Noor Hisham Abdullah.
Dr Noor Hisham, who also chairs the Medical Device Authority in charge of the enforcement of the regulations, said there were some 70,000 existing medical equipments that need to be registered.
“One of the issues raised in the past is that medical devices were not regulated and we don’t want to be a dumping ground, where medical devices are being used but not being monitored according to the standard or the benchmark of the devices.
“So, the Medical Device Authority has taken this role to make sure all medical devices will be registered and licensed,” Dr Noor Hisham said at a press conference here after the launch of the Medical Device Centralised Online Application System (MedCast).
MedCast, an online platform for the registration of medical devices and the licensing of establishments as stipulated under the Act, was launched by Health Minister Datuk Seri Dr S. Subramaniam.
Under Act 737, all medical device establishments will be given a one-year transition period, starting yesterday, to apply for licensing with the authority.
In the name of safety, this is a good move. However it will mean more layers of red tape and bureaucracy for the practice of medicine in this country. If run right, hopefully it will not be too troublesome but we shall see.
In the meantime, we have updated our Public sector Departments listing to include the MDA website.
Now should I register my pen torch, stethoscope, tape measure, BP set….. hmmm….