Malaysia Authorized Representative

Malaysia MDA allows multiple authorized representatives for medical devices

The Malaysian Medical Device Authority (MDA) now allows for multiple authorized representatives for medical devices. This was announced on 14 September 2021, by repealing Circular Letter No. 1/2014 for Establishments Carrying Out the Role as an Authorized Representative (AR) and Establishments Carrying Out Various Activities, which was effective as of 17 June 2021 in accordance with the decision made in MDA Meeting No. 2/2021.

This means that as of 17 June 2021 the MDA no longer limits medical device registrations to a single authorized representative and so allows the registration of a single medical device by multiple authorized representatives. The MDA also no longer limits the importation and placing of medical devices on the Malaysian market to one authorized representative.

Medical device manufacturers are free to register their medical device as many times as they wish, for example should a distributor not perform as expected then a new distributor can be appointed, however registration costs will double as well as the delay in getting to market by having to register again. To overcome this situation, manufacturers may still appoint an Independent Authorized Representative to register their medical device who then issues Letters of Authorization to as many distributors as desired.

What’s more, by repealing Circular Letter no.1/2014, the Medical Device Authority no longer allows the combining of license applications. Previously, one license application could be submitted to cover various activities such as manufacture, authorized representation, importation, and distribution. This is no longer allowed. One license application must be made per activity.

The implications for medical device manufacturers in choosing a partner in Malaysia is that they must now be licensed for the exact function they are to carry out i.e., an Authorized Representative license to register medical devices, an importer’s license for importing, a distributor’s license for distribution. Please be aware that importers and distributors may decide not to apply for Authorized Representative licenses in order to register medical devices. And please note that in light of the current situation of the Covid-19 pandemic in the country, the implementation of this second component has been postponed and will be implemented at a future date.

If you have any queries as to how this change will affect your medical device, please contact the Regulatory Affairs Specialist who is looking after your dossier.

To learn more about registering medical devices in Malaysia click here.

To learn more about the medical device market in Malaysia click here

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