Mandatory Medical Devices Registration By 2008, Says Dr Chua

PUTRAJAYA, Jan 12 (Bernama) -- The voluntary registration scheme for medical devices establishments (MeDVER) was launched Thursday, with Health Minister Datuk Dr Chua Soi Lek expressing the hope that mandatory registration can be implemented by 2008.
He also announced that a proposal to establish a department to oversee the development of the medical devices regulatory system had been approved by the authorities concerned.
It will be called the Medical Devices Bureau to be housed within the ministry's Engineering Division. Twenty-two posts have been approved for the new department.
Speaking at the launching of the MeDVER here, he said: "In view of the fact that there are no less than 400,000 different types of medical devices using diverse technology in the market, I believe that the bureau has a heavy task ahead.
"Nevertheless, I expect that by the time mandatory registration and full enforcement of regulations is introduced, probably by 2008, they will already be well placed to carry out their responsibilities effectively."
Dr Chua said the first phase of the voluntary registration scheme would only cover medical devices manufacturers and their representatives, exporters, importers, distributors and vendors of such devices.
"We will gather information on the profile of the establishments. As for medical devices, only limited information will be required at this stage," he said.
The minister said the scheme was meant to create awareness and familiarise all the parties involved with the upcoming medical devices regulations that would be implemented in stages.
He further said a well-conceived and appropriate regulatory framework would prevent sub-standard, unsafe and ineffective devices from entering the market and instil consumer confidence in the medical devices industry.
It was reported that the world's market for medical devices would exceed US$260 billion this year. And in 2005, Asia's healthcare market alone constituted about 45 per cent of the global healthcare market.