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Medical Devices Industry in Malaysia

Malaysia is continuing to maintain its position as a leading producer and exporter of medical gloves and catheters in the world. The country supplies about 80% of the global market for catheters and about 60% for medical gloves. The manufacture of medical gloves has moved up the value chain, with better quality and specialty gloves being made like powder free medical gloves, safety gloves, and clean room gloves.
Other medical device products made in Malaysia are surgical equipment, syringes, blood transfusion sets, blood pressure transducers, medical gases, hypodermic /spinal/AV fistula needles, medical tubes & bags, dialysis solutions, orthopaedic products, diagnostic radiographic equipment, and procedural kits.
Even though the medical industry in Malaysia is presently focussed on the rubber-based products, more companies are beginning to manufacture non-rubber based products made from plastics, silicone and metal alloys. This sector is expanding its manufacturing value chain by making a shift from basic processes and conventional assembly to design and prototyping, product and process research & development, distribution and logistics. 
Most medical products manufactured in Malaysia are self-regulated and conform to internationally recognised quality standards like the Food and Drug Administration (US), Department of Health (UK), and Bundesgesundheitsamt (Germany).
The Ministry of Health, Malaysia has employed the medical devices regulatory system in phases. Voluntary registration of medical device institutions was launched on January 12, 2006. Compulsory registration and full enforcement of the rule is expected to be ready by 2010. A new department within the Ministry of Health's Engineering Division, the Medical Devices Bureau has been set up to supervise the development of the medical devices regulatory system. It has been agreed in theory that the rules would be aligned to the directives drawn up by the ASEAN Harmonisation Working Party (AHWP) and the Global Harmonisation Work Force (GHTF).
The medical devices sector is one of the sectors classified for promotion and further development, given the increasing demand for medical products. There is a strong incidence 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 a perfect place for the manufacture of medical devices with the potential to be developed into a medical device centre in Asia.
Investment Opportunities
The huge majority of `high-end' medical equipment are imported from abroad and the government expects to promote manufacture of more advanced devices in the following areas :-
  • Orthopaedic products
  • Wound care products
  • Electromedical equipment
  • Cardiovascular products
  • Ophthalmic products
  • In-vitro diagnostic devices
  • Home care products

Last Updated on: 18-11-2009

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