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Malaysia: MDA Announces Harmonized QMS Standards for Medical Device Registration in 2024

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 13485Class A, B, C, D application
Quality Management System Requirement for Foreign Legal Manufacturer
ISO 13485Class A, B, C, D application
US Quality System (QS) regulation (21 CFR Part 820)Class A, B, C, D application
Japan MHLW Ordinance 169Class A, B, C, D application
ISO 9001Empty Gas Cylinder application only
Traceability Form
Declaration of Traceability of Evidence of Conformity- QMS from manufacturing site/ OEMClass A application

For further details, please refer to the official announcement which can be accessed here.

Additionally, Quality Management System (QMS) requirements and the Traceability Form are accessed here.

Should you have any enquiries or require clarification concerning the withdrawal of these guidance documents, please don’t hesitate to reach out to us. You can contact us or click the button below.

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