Based on the General Directive of the Minister of Health No.1/2024, announced on 15 April 2024, following the provisions of the Medical Device Authority Act 2012 (Act 738): Implementation of the One License Per Establishment Role Policy”, establishments are not allowed to combine license applications for the activities of manufacturers, authorized representatives, importers, or distributors under a single license.
Hence, any establishments with multiple roles under a single license and require license renewals must comply with the following actions effective from 1 July 2024;
Choose only one establishment role to retain under the renewable license
Discontinue other establishment roles and apply for new licenses for each role accordingly.
A new application to obtain the establishment license applies only to one role per application. For renewable licenses, establishments must select only one role to retain and complete the following form: Establishment Role Update Form. The implementation phase is expected until the end of the year 2027 and any establishments that may be affected were requested to fill in the Fee Refund Application Form (Refund – Single License) so MDA can refund the excess fee.
Please refer to the table below for a better understanding of the license type and its permitted activities, and the linked document for the License Renewal Procedure.
MDA advised retaining the Authorized Representative role in the renewable license to facilitate the medical device registration application, notification changes application and post-market activities. Establishments may contact the MDA License Unit directly via license-unit@mda.gov.my for more information.
Source: Medical Device Authority (MDA)
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