Tuesday, July 02, 2013

Medical tools to be registered within two years

 The Star Online

PUTRAJAYA: 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.
The establishment licensing ini­tiative covers manufacturers, autho­rised representatives of foreign manufacturers, importers and distributors.
Registration of both medical devices and vendors would enable the authorities to carry out inspections on the equipment to ensure ongoing compliance, said Dr Noor Hisham.
“They can register from anywhere – from home or their offices, in the country or overseas. This marks a significant milestone for the Health Ministry in discharging our responsibility to protect the public in terms of patient safety and use of medical devices,” he added.
More information can be obtained from the Medical Device Authority website on www.mdb.gov.my

No comments: