BY LOH FOON FONG
FOONFONG@THESTAR.COM.MY
PETALING JAYA: Imagine surgical stitches ripping apart after a patient is discharged or a metal plate implanted in a leg breaking weeks after the operation.
Such scenarios have happened because of substandard medical devices.
The Medical Device Regulations 2012, which comes into effect today, is aimed at minimising situations like these.
The new law would help ensure that manufacturers of medical devices adhere to set standards.
Medical devices are defined as any instrument used for the use of diagnosis, prevention, monitoring and or for treatment of disease and injury.
They would be categorised into A, B, C or D, depending on the risk level and intended use.
Under the regulations, those producing or importing these items must register the products with the Medical Device Authority (MDA), a body under the Health Ministry tasked with supervising the country’s medical devices industry.
They would be given two years to register the devices while companies dealing with the devices, including manufacturers, importers and distributors, would be given a year to apply for licences from the ministry.
Health director-general Datuk Dr Noor Hisham Abdullah said the new regulations would help ensure the safety and effectiveness of devices being used in the country.
“Patients and other customers will be protected from substandard or unapproved medical devices,” he said.
The new regulations would also shield buyers from misleading or fraudulent advertisements, as it is mandatory for all claims to be supported by evidence.
Dr Noor Hisham said the protection provided by the regulations included misuse of devices by unqualified or untrained personnel.
“Manufacturers, importers and distributors of medical devices are also compelled to report any adverse incidents or faults involving their products.
“This is mandatory and applies even if an incident occurs outside Malaysia,” he added.
The cases could be faults in devices, deterioration in effectiveness or inadequate labelling or instructions.
Dr Noor Hisham said an incident must be reported to the MDA within 30 days of occurrence.
“But if the incident results in death or serious deterioration in the health of a patient, it must be reported within 10 days.”
“And if the incident poses a serious threat to public health, it must be reported within 48 hours,” he added.
This regulatory reform in the medical device industry comes under the National Key Economic Area for Healthcare within the National Economic Transformation Programme.
Higher standards for those making medical devices
PETALING JAYA: The Medical Device Act is expected to shake up companies producing medical devices.
Association of Malaysian Medical Industries (AMMI) chairman Hitendra Joshi said small and medium enterprises (SMEs) would have to comply with quality and safety standards.
“While multinationals and some local companies have complied with international standards, some SMEs have to move up the value chain,” he said.
Hitendra, who is based in Penang, said the standards under the Medical Device Regulations would help Malaysia be recognised as a reliable producer of medical devices in the global market.
“It would help attract foreign direct investment with increased market confidence,” he said.
AMMI secretary S. Balasubramaniam said the regulations would also enable more joint ventures with foreign companies.
The association comprises 45 member companies which collectively account for more than 50% of the country’s total export revenue for medical devices.
The industry recorded sales of RM6.5bil last year, based on the AMMI’s survey on 67% of its members.
According to the survey, Malaysia’s medical device exports last year totalled RM12.9bil, with RM5.9bil coming from AMMI members.
The association expects exports to increase to RM13.7bil this year.
Medical gloves and catheters made up RM9.8bil of the total value last year while instruments for medical, surgical and dental practices, electro-mechanical devices, contraceptives, ophthalmic lenses, radiation devices and orthopaedic implants made up RM3.1bil.
Most of the companies producing theses products are located in the Northern Corridor Economic Region covering Penang, Kedah, Perak, Perlis, besides in the Klang Valley and Iskandar Malaysia in Johor.
Malaysian-made medical devices were mainly exported to Asia Pacific countries, Japan, United States, Canada and Europe.
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