Medical Device Regulations 2012 effective 1st July 2013

The Malaysia Medical Device Regulations 2012 comes into effect today, 1st July 2013. It is to ensure that manufacturers of medical devices adhere to set standards. Medical devices would be given two years to register with the Medical Device Authority. Companies dealing with the devices, including manufacturers, importers and distributors would be given a year to apply for licences from the Ministry.

Association of Malaysian Medical Industries (AMMI) chairman Hitendra Joshi, 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 investments with increased market confidence,” he said. AMMI secretary S. Balasubra­maniam said the regulations would also enable more joint ventures with foreign companies.

AMMI 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 ( Source: the STAR dd 01-07-2013).