Malaysia, a key gateway to Southeast Asia, offers strategic access for businesses. Understanding medical device regulations is crucial for market entry.
Malaysia is centrally located within Southeast Asia, and is an ideal regional gateway for overseas companies to venture into Southeast Asia. In the north, Perlis, Kedah, Perak and Kelantan share a border with Thailand and people on either side speak both Thai and Malay. In Sabah, the Malay diaspora extends to the southern part of the Philippines which has aporous border. Malaysia also shares a land border with Indonesia and Brunei in the island of Borneo. In the South, its border with Singapore allows thousands of people to commute each day for work and trade.
The Malaysian medical device market is an important one, given its significant size and potential for growth. However, before medical devices can be marketed and sold in Malaysia, they must be registered with the Malaysian Medical Device Authority (MDA) and comply with the country's regulatory requirements, to ensure that products are safe, effective, and of high quality.
For companies to register and hold MDA medical device certs, they must first obtain what is known as an “Establishment licence”, of which the detailed requirements are specified under Section 15 of the Medical Device Act 2012 (Act 737). All establishments as defined in Section 2 of the Act 737 shall obtain a license/licenses before they can import, export or place a medical device in the market.
Pure Malaysia is now able to act as your Authorized Representative (AR) in Malaysia. By having a neutral third party such as Pure Global hold your MDA medical device licence, you can easily switch distributors immediately without the hassle of re-registering your product with MDA which may take 6 months or more.
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