Based on the Decision from the Mesyuarat Jawatankuasa Teknikal Pendaftaran Umum 2023, the Medical Device Authority of Malaysia (MDA) has established a transition period for specific requirements until December 31, 2023. Starting January 1, 2024, only the recognized Quality Management System (QMS) standards outlined in Table 1 will be accepted for new and re-registration of medical devices. These standards apply to both local and foreign legal manufacturers. Additionally, a Traceability Form is required for Class A applications.
Table 1: QMS requirements and traceability form
| Quality Management System Requirement for Local Manufacturer | |
| ISO 13485 | Class A, B, C, D application |
| Quality Management System Requirement for Foreign Legal Manufacturer | |
| ISO 13485 | Class A, B, C, D application |
| US Quality System (QS) regulation (21 CFR Part 820) | Class A, B, C, D application |
| Japan MHLW Ordinance 169 | Class A, B, C, D application |
| ISO 9001 | Empty Gas Cylinder application only |
| Traceability Form | |
| Declaration of Traceability of Evidence of Conformity- QMS from manufacturing site/ OEM | Class A application |
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