Andaman Medical Regulatory Affairs Update Malaysia

Malaysia: MDA Announced Regulation Governing the Implementation of the Policy of One License for Each Establishment Role

On April 15th, 2024, Malaysia’s Medical Device Authority (MDA) announced the General Directive of the Minister of Health No. 1/2024 Pursuant to the Provisions of the Medical Device Authority Act 2012 [Act 738], regarding the Implementation of the Policy of One License for Each Establishment Role. This requirement applies to establishments that act as authorized representatives (AR) and establishments that carry out various activities. Concerning the Cancellation of the Medical Devices Authority’s (MDA) Circular Letter No. 1/2014, Establishments are no longer permitted to combine license applications for the operations of manufacturers, authorized representatives, importers, or distributors under the same establishment license.

Accordingly, in compliance with the Fifth Schedule of the Medical Devices Regulations 2012, establishments that have previously combined multiple roles under a single license and wish to renew their license may apply for the license renewal application procedure from the Licensing Branch, Pre-Market Control Division. Their application will be reviewed for approval and a refund of fees will be granted based on the license renewal fee.

The announcement can be obtained from the Medcast 2.0+ system’s homepage, which can be accessed here.

A full version of the General Directive of the Minister of Health No. 1/2024 can be found here (in Malaysian language).

If you have any queries about this draft guidance, please contact us at sales@andamanmed.com or click the button below.

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