Regulatory Affairs Update: Malaysia

Malaysia: Announcement on Faster Approval for Establishment License Application 

On March 25th, 2024, the Medical Device Authority (MDA) of Malaysia published an announcement regarding faster approval for establishment license applications. The complete applications will be processed within 14–21 working days after the review officer receives them.

The following elements will be reviewed during the evaluation process:

  1. An updated Letter of Authorization (LOA) with accurate address information in the prescribed format.
  2. An updated list of medical devices on attachment 1.
  3. Confirmation that the Person Responsible is from the list of directors listed in Form 49, or
  4. An appointment letter for the Person Responsible, signed by a director listed in Form 49 and appointed by the company’s top management.
  5. An updated Quality Management System (QMS) report and a valid certificate.
  6. A QMS report prepared by a registered Conformity Assessment Body (CAB).

Important Notes:

  • Incomplete applications without the above elements will be returned once to the applicant, who must complete it and/or provide the information, particulars, and/or documents within 30 working days.
  • The application will be rejected if any information, particulars, or documents as requested are not provided to the MDA within 30 working days or the application is returned without the requested information, particulars, or documents.
  • This will not affect the applicant’s right to make a new application, and the application fee is not refundable.

Further information on this announcement can be accessed here.

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