Malaysia: Decision on the Implementation and Requirements of QMS and Traceability Form

General Registration Technical Committee Meeting by Medical Device Authority (MDA) has made the decision on the requirements of quality management system (QMS) and Traceability Form.

The transition period for the requirements has been decided to be allowed until 31 December 2023. The QMS requirements stated in the table below will be enforced starting from 1 January 2024 for all new and re-registration of medical devices.

Requirement of Quality Management System for Local Manufacturers

Requirement of Quality Management System for Foreign Legal Manufacturers

Traceability Form

Source: Medical Device Authority (MDA)