As it is a highly diversified industry, it produces a broad range of products and equipment ranging from medical gloves, implantable devices, orthopaedic devices and dialysers to diagnostic imaging equipment and minimal invasive surgery equipment and other devices which can be used for medical, surgical, dental, optical and general health purposes.
To date, the medical devices industry in Malaysia is made up of more than 190 companies dominated by small and medium companies (SMIs) of which mostly are manufacturers of medical gloves. More than 20 medical devices Multinational Corporations (MNCs) producing non-medical gloves have made Malaysia their offshore location for their manufacturing operations. Major MNCs such as Agilent, B. Braun, St. Jude Medical, C.R. Bard, Symmetry Medical, Teleflex, Resmed, Convatec, Ciba Vision (a subsidiary of Novartis), Accellent, Kelpac Medical, Eurocor, Criticare, Ambu, Toshiba Medical Systems and Haemonetics have investments in Malaysia.
The medical devices industry has been identified as one of the growth areas and has been included under the Healthcare NKEA, whereby eight (8) Entry Point Projects (EPPs) for the medical devices sub-sector was announced by the Government which will create RM17.12 billion in revenue and RM11.4 billion in GNI and generate 86,000 jobs by 2020.
The Malaysian medical devices regulation was being implemented in stages. The first stage of voluntary registration of establishments was launched in 12 January, 2006. The Medical Device Act has been passed by the Parliament and gazetted on 9 February 2012. With the enforcement of the Medical Device Act, commencing on 1 July 2013, all medical devices manufactured, imported or sold in Malaysia are required to be registered. A transition period of two years for medical devices products registration and one year for establishment licensing will be given to the industry before it is fully enforced. The Medical Devices Regulations 2012 is aimed to protect patients and other customers from substandard and unapproved medical devices. Medical devices would be categorised into A, B, C and D depending on the risk level and intended use. Under the regulations, those producing or importing these items must be registered with the Medical Device Authority, a body under the Ministry of Health Malaysia responsible in supervising the medical devices industry. The Medical Device Regulations would help Malaysia to be recognised as a reliable producer of medical devices in the global market, help to attract foreign direct investment with increased market confidence and enable more locals to joint venture with foreign companies.
There is a strong presence of established supporting industries conforming to world-class standards which supporting the medical devices industry in Malaysia. The supporting industries are capable of meeting the needs of the medical devices industry such as sterilisation services, sterile medical packaging, electronic manufacturing services (EMS), precision engineering, tools and dies making contract moulding and machinery fabrication. The availability of the supporting industries has positioned Malaysia as an ideal location for the manufacture of medical devices and global supplier of parts and components, with the potential to be developed into a medical devices hub, for both manufacturing and R&D in Asia.
The following growth areas are being promoted:-