Industries in Malaysia
Medical Devices Industry
The medical devices industry in Malaysia is dominated by companies engaged in the production of medical gloves and other medical disposable products. Malaysia continued to maintain its position as the world's leading producer and exporter of medical gloves and catheters, supplying 80 per cent of the world market for catheters, and 60 per cent for rubber gloves.
Currently there are more than 180 medical devices manufacturers in Malaysia including some major foreign multinational corporations (MNCs) which are involved in other high valued products such as othopaedic products, dialysers, surgical instruments, medical electrodes, catheters, diagnostic radiographic equipments, safety intravenous cannulae, sutures as well as ophthalmic lenses.
Most medical products manufactured in Malaysia are self-regulated and conform to internationally recognised quality standards such as the Food and Drug Administration (United States), Department Of Health (United Kingdom) and Bundesgesundheitsamt (Germany).
The Ministry of Health, Malaysia has implemented the medical devices regulatory system in stages. The Medical Devices Act was gazetted on 15 March 2012 and the mandatory registration as well as full enforcement of the regulation is expected to be in place by October 2012. The Medical Devices Authority has been established to oversee the implementation of the medical devices regulatory system. It has been agreed in principle that the regulations would be aligned to the guidelines drawn up by the ASEAN Harmonisation Working Party (AHWP) and the Global Harmonisation Work Force (GHTF).
The medical devices sector is one of the priority sectors identified for promotion and further development, given the growing demand for medical products. There is a strong presence of established supporting industries ranging from sterilisation services, sterile medical packaging, precision engineering and tool and die making to contract moulding and assembly and machinery fabrication in Malaysia. The availability of the supporting industries positions Malaysia as an ideal location for the manufacture of medical devices with the potential to be developed into a medical device hub in Asia.
With a strong presence in supporting industries for the medical devices industry, expansion in production of higher quality and technology as well as sophisticated medical devices is also expected to continue. This is in line with the Healthcare National Key Economic Area (NKEA) which aims to develop the medical technology sub-sector such as medical devices, diagnostic equipment and healthcare information technology.
The vast majority of `high-end' medical equipment are imported from abroad, and the government hopes to encourage production in the following areas:-
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