Imported medical devices and pharmaceuticals must be registered with the Malaysian Ministry of Health (MOH) by a local authorized representative (for medical devices) or a product registration holder (for drugs). In order to meet this requirement, foreign pharmaceutical or medical device companies can set up a local subsidiary, use a distributor as their local representative, or engage an independent third party.
What are the requirements and responsibilities for a local agent in Malaysia?
- The local agent must have a permanent address in Malaysia.
- The local agent is in charge of managing your product registration in Malaysia, and also liaising with the MOH for product changes, manufacturing changes, adverse event reporting, etc.
What are the advantages of using an independent third party as your local agent in Malaysia?
- For foreign medical products companies who do not want to set up a subsidiary or trust their proprietary information to a distributor, an independent third party acting as your Malaysian local agent is the best choice.
- Using an independent third party will allow you to change distributors if you want — something that is much more difficult if your distributor holds your product licenses.
Pacific Bridge Medical is highly experienced with medical device and pharmaceutical regulations in Malaysia and can act as your in-country representative. Please contact us today to learn more about the services we can provide as your Malaysian local agent.
Need more information?
Visit our Resource Center to view free webcasts and charts or read publications, news, and research reports on the Asia medical markets.