The Medical Device Authority (MDA) is committed to enhancing the efficiency and speed of the establishment license application assessment process. We are pleased to announce that complete applications will now receive approval within 14-21 working days from the date the application is received by the evaluation officer.

During the evaluation process, the following elements will be reviewed:

1. An updated Letter of Authorization (LOA) with accurate address information and 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 to complete it and/or provides the information and/or 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.
  • However, this will not affect the right of the applicant to make a new application, and the application fee is not refundable.

Thank you.

Pre-Market Control Division
Medical Device Authority
25th March 2024