PETALING JAYA - The Medical Device Act 2011 will help ensure the quality and safety of medical devices once it is enforced.
Health director-general Datuk Seri Dr Hasan Abdul Rahman said products such as facial fillers and breast implants would be register-ed with the Medical Device Authority.
"All companies dealing with medical devices will be licensed so that authorities can monitor the performance of medical devices in the market and take action once the Act is enforced." he said.
Dr Hasan was responding to reports asking for tighter regulations of such cosmetic procedures like anti-ageing injections in Britain recently.
This followed fears that harmful dermal fillers could be the next scandal in the cosmetic surgery industry following the breast implant scare in France.
"Under the Act, a 'designated medical device' would be regulated to ensure its usage complied with certain requirements," he said.
Dr Hasan added that anyone who used the device must possess a permit issued under the Act.
"This permit will only be issued to a person who has the necessary qualification and experience," he said.
He added that once the Act was fully enforced, the marketing and usage of such devices would be regulated.
"For a medical device, the manufacturer must demonstrate evidence that the filler will not compromise the clinical condition or safety of users," he said.
He stressed that although facial fillers were not regulated as medicines, the provisions under the Act would allow the ministry to put in place all the appropriate steps to address safety issues.