Market Opportunity in Malaysia
The medical device industry in Malaysia is a rapidly growing industry with extensive opportunities for investors, local manufacturers, importers and exporters
The medical device industry in Malaysia consists of three sectors: 1 – manufacturers, 2 – suppliers of raw materials and services to the medical device manufacturing companies and 3 – importers and exporters of medical devices. This industry has been included under the Healthcare NKEA, whereby eight (8) Entry Point Projects (EPPs) for the medical device sub-sector were announced by the Government. These will create RM17.12 billion in revenue and RM11.4 billion in GNI, and is likely to generate 86,000 jobs by 2020.
In addition, a number of incentives have been made available for investment, for example, incentives for operational headquarters (OHQ), regional distribution centres (RDC), Research & Development (R&D), International Procurement Centres (IPC) and many others. With the implementation of the Medical Device Act 737, commencing in 2013, all medical devices manufactured, imported or sold in Malaysia are required to be registered.
Under the regulations, those producing or importing these items must be registered with the Medical Device Authority (MDA), a body under the Ministry of Health Malaysia responsible in supervising the medical device industry. Not only do the medical device regulations ensure that Malaysia is recognised as a reliable producer of medical devices on the global stage, they also assist in attracting foreign investment with improved market confidence and support joint ventures between local and foreign companies.
Andaman Medical can act as your in-country representative
If the medical device manufacturer is not present in Malaysia, it is required to authorize an authorized representative to act on its behalf to conduct the conformity assessment as laid out in the Medical Device Regulations. Andaman Medical can be the appointed as the local authorized representative for those companies that do not have an establishment that is operating in Malaysia. As a local authorized representative, Andaman Medical can liaise with both the MDA and the company to ensure that an appropriate conformity assessment is completed.
In addition, Andaman Medical has the in-house expertise to support a company in preparing submission files that comply with specific local regulations. We will provide a responsive service to address the submission and compliance requirements for the medical device industry. Andaman Medical can also provide support and guidance throughout the application process for a Malaysian establishment license right up until approval is granted!