Medical Device Establishment Licensing Rules Set to Take Effect in Malaysia

Update on June 26, 2014: Establishment license requirements apply to medical device manufacturers, authorized representatives and distributors based in Malaysia, not foreign companies.

Requirements that medical device companies commercialized in Malaysia obtain establishment licenses will come into force on June 30, 2014. Following that deadline, any domestically based medical device manufacturer, authorized representative or distributor that has not either obtained or applied for a device license may not conduct medical device-related business in Malaysia.

Firms that have already applied to the Malaysian Medical Device Authority (MDA) for establishment licenses but have not yet paid application fees must do so before June 30, as well.

Companies that have not yet begun the application process for establishment licensing should do so through the MDA’s Medical Device Centralised Online Application System (MeDC@St) ahead of the June 30 deadline in order to stay in full compliance with Malaysian medical device registration requirements.

Foreign manufacturers do not require establishment licenses in Malaysia; however, their Malaysia authorized representatives and distributors are subject to the MDA's deadline for establishment licenses. 

Stewart Eisenhart

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