Русскоязычный заголовок: Производство медицинских материалов и оборудования в Малайзии
Виробництво медичних матеріалів та обладнання в Малайзії (англ.)
Medical Devices Industry
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.
The production of medical gloves has moved up the value chain, with higher quality and specialty gloves being manufactured such as low protein, powder free medical gloves, safety gloves and clean room gloves.
Other medical device products manufactured in Malaysia include syringes, surgical equipment, blood transfusion sets, blood pressure transducers, dialysis solutions, medical gases, hypodermic /spinal/ AV fistula needles, medical tubes & bags, diagnostic radiographic equipment, orthopaedic products and procedural kits.
Although the medical industry in Malaysia is currently concentrated on the rubber-based products, more companies are moving into the manufacturing of non-rubber based products made from plastics, silicone and metal alloys. The medical devices sector is expanding its manufacturing value chain by moving from basic processes and conventional assembly to product and process research & development, design and prototyping, distribution and logistics.
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. Voluntary registration of medical device establishments was launched on 12 January, 2006. Mandatory registration and full enforcement of the regulation is expected to be in place by 2010. A new department within the Ministry of Health's Engineering Division, the Medical Devices Bureau has been established to oversee the development 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.
The vast majority of `high-end' medical equipment are imported from abroad, and the government hopes to encourage production of more advanced devices in the following areas :
- Electromedical equipment
- Cardiovascular products
- Orthopaedic products
- In-vitro diagnostic devices
- Wound care products
- Ophthalmic products
- Home care products