What to Consider When Selecting a Malaysian Local Authorised Representative in the Medical Devices Industry

by | Jan 19, 2017 | 0 comments

What to Consider When Selecting a Malaysian Local Authorised Representative in the Medical Devices Industry

 

The medical device industry in Malaysia represents one of the national key economic growth areas (NKEA) within the healthcare sector. To fully optimize the economic potential of this industry, the Malaysian Government planned out and implemented 8 Entry Point Projects (EPPs) that are expected to generate approximately RM 17.12 billion in revenue, and RM 11.4 billion in gross national income. The Entry Point Projects are expected to create 86,000 jobs by the year 2020.

 

This is great news for manufacturers, distributors, importers and exporters of medical devices who have invested in the technology, equipment and R&D in order to be a part of this economic goldmine. The Medical Device Authority of Malaysia under the Ministry of Health defines ‘medical devices’ as any non-medicinal products used by the healthcare industry for the “diagnosis, prevention, monitoring or treatment of any illness or disability”. The guidelines themselves recognize that this is an extremely wide range of products, ranging from consumer-end merchandise to more complex equipment for medical centres.

 

There is, however, a considerable obstacle for companies who have exemplary medical devices to offer consumers and operators in the Malaysian healthcare industry: when touching base for the first time in Malaysia or Asia, securing the kind of licensing, medical device registration, export permits, and other certification needed to operate successfully in the region is a time-consuming and understandably complicated process which requires efficient, consistent communication with the proper regulatory officials and authorities and an in-depth understanding of regulatory requirements.

In those circumstances, it’s best to hire a local authorised representative (AR), a Malaysian local authorised representative or a professional who acts as your liaison with the Medical Device Authority (MDA) of Malaysia.

The MDA’s web-based application system guidelines state that only Malaysian authorised representatives may register medical devices online. An authorised representative must be a Malaysian citizen or permanent resident, and must hold an Establishment License and a certificate of Good Distribution Practices, Medical Devices.

It is usually recommended that foreign healthcare and medical devices companies hire an independent Malaysian local authorised representative (a professional or firm that is not also your distributor in the region), to ensure the integrity of this agent in accomplishing your primary aim: to operate and succeed in total compliance to the ever-changing regulatory requirements and policies in Malaysia and other rapidly developing countries in the Southeast Asian region.

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