If you’re interested in selling your medical device in Malaysia but have no local presence in the country, medical device market regulators require that you appoint a Malaysia Authorized Representative.
Malaysia Authorized Representative requirements
As in many other markets, your Authorized Representative serves as your regulatory liaison with Malaysia’s Medical Device Authority (MDA) and is responsible for managing your medical device registration.
Your Malaysian Representative must be a citizen or permanent resident of Malaysia. The representative must also hold an Establishment License and a certificate of Good Distribution Practices, Medical Devices (GDPMD).
Can your distributor serve as your Authorized Representative to the MDA in Malaysia?
Many medical device manufacturers consider the option of appointing a distributor as their Malaysia Authorized Representative. This can be risky, as distributors are primarily focused on sales and marketing, rather than new and changing regulatory issues. Also, your Malaysian Authorized Representative controls your device approval so switching to another representative later (example: to switch distributors) could present a problem.
We recommend selecting an independent authorized representative that is committed solely to ensuring your firm stays ahead of regulatory requirements in Malaysia.
Read more about the benefits of hiring an independent authorized representative.
Choose Emergo as your Malaysia Authorized Representative
With offices in Kuala Lumpur, Emergo has the expertise and resources to perform all duties required of your Authorized Representative. Here’s how we can help:
- We will submit all necessary medical device registration documents for review and assist with any follow-up questions from the MDA.
- Our consultants are up to date on the latest Malaysian medical device regulations and will ensure that you experience a smooth and efficient registration process.
- We will add distributors as allowed to import products.
- If desired, we can use your Malaysia registration dossier to ease your entry into additional Southeast Asian medical device markets such as Singapore.
Please contact us for more information on how we can act as your Malaysia Authorized Representative.