The Medical Device Authority (MDA) has announced the approval of a minor amendment to Circular Letter No. 1 Year 2025. The revised document is now designated as Circular Letter No. 2 Year 2025 (“the Circular”) and took effect on 30 September 2025.
Scope
Summary of the latest update issued by the Medical Device Authority (MDA), Malaysia, concerning conformity assessment procedures for medical devices approved by recognised countries.
Key Highlights
- Policy Update The MDA now accepts pre-market approvals issued by the following recognised authorities for conformity assessment through verification:
- Health Sciences Authority (HSA), Singapore
- Food and Drug Administration (FDA), Thailand
- Updated Guidance Document
The list of recognised foreign pre-market approvals has been revised and incorporated into MDA/GD/0068 – Guide for Conformity Assessment Body (CAB): Conducting Conformity Assessment Through Verification. - Supersession
Circular Letter No. 1 Year 2025 has been revoked and replaced by Circular Letter No. 2 Year 2025.
Attachment
See attached the circular issued by the Medical Device Authority (MDA) titled “Conformity Assessment Procedures for Medical Device Approved by Recognised Countries”. [PDF]
Effective Date
30 September 2025
Implications to Clients
Stakeholders are advised to review the updated Circular and Guidance Document to ensure compliance with the new conformity assessment requirements. This policy simplifies the acceptance of foreign approvals, thereby streamlining the assessment process for medical devices in Malaysia. Future revisions to the Guidance Document will continue to apply.
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