On September 12, 2025, the Medical Device Authority (MDA) of Malaysia released the Second Edition of Guidance Document MDA/GD/0070. This updated guide provides establishments, manufacturers, and authorised representatives with revised instructions for medical device registration and abridged conformity assessment via the MeDC@St system. The revisions align with the Medical Device Act 2012 (Act 737), the Medical Device Regulations 2012, and Circular Letter No. 1/2025.
Scope
The updated guidance document establishes clearer pathways for conformity assessment and verification processes for medical device registration. It introduces significant changes regarding recognised regulatory authorities, documentation requirements, and submission timelines.
Key Highlights
The main changes introduced in the Second Edition of MDA/GD/0070 include:
- Expanded Recognition of Authorities: Singapore’s Health Sciences Authority (HSA) and Thailand’s Food and Drug Administration (Thai FDA) are now recognised as regulatory authorities. Pre-market clearance or approval from these agencies is eligible documentation for the verification process (Annex 1 and Annex 4).
- Conformity Assessment Evaluation Pathways and Eligibility Criteria: The one-year marketing requirement for devices in specific jurisdictions has been removed in Table 1.
- Verification Pathway Clarifications: Table 2 now includes medical devices from Singapore and Thailand that are not eligible for the verification pathway as they fall under specific schemes or programs.
- Post-Market Surveillance and Vigilance: The required data for Post-Market Surveillance and Vigilance has been changed to cover the past 3 years instead of the previous 3-to-5-year range.
- Terminology Changes: The term “verification assessment” has been updated to “verification process” across the document.
A summary of other important changes can be found in the table below.
No | Edition no. | Section | Description of changes | Published date |
| First | All | Initial release | March 2025 |
1 | Second | 4.3 Conformity Assessment Pathways | Removed the phrase ‘has been marketed for at least one year in the respective agencies’ jurisdictions’ under Verification (initial certification assessment) as in Table 1 | 11 September 2025 |
2 |
| Table 2 : Schemes/ programs exempt from verification pathway for medical device | Added information on schemes or programs not subject to verification pathways for Singapore (HSA) and Thailand (Thai FDA) |
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3 |
| ANNEX 1 (normative) | Added Singapore (HSA) and Thailand (Thai FDA) as recognised regulatory authorities |
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| RECOGNIZED REGULATORY AUTHORITIES OR NOTIFIED BODIES |
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4 |
| ANNEX 3 (informative) | Revised Section 9: Post-Market Surveillance and Vigilance – amended text from ‘past 3 to 5 years’ to ‘past 3 years’. |
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| SUBMISSION GUIDE FOR CLASS A MEDICAL DEVICE REGISTRATION APPLICATION IN MeDC@St FOR NEW AND RE- REGISTRATION APPLICATION |
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5 |
| ANNEX 4 (normative) |
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| SUBMISSION GUIDE FOR CLASS B, C, AND D FOR CONFORMITY ASSESSMENT BY CAB AND SUBMISSION OF APPLICATION IN MeDC@St FOR NEW AND RE- REGISTRATION APPLICATION |
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These changes aim to streamline submissions, reduce administrative burden, and ensure alignment with evolving regional regulatory frameworks
Attachment
See the Second Edition Guidance Document MDA/GD/0070 published by the Medical Device Authority (MDA)
Effective Date
The Second Edition of MDA/GD/0070 is effective immediately upon publication on September 12, 2025.
Implications to the Client
Clients should review the revised guidance to align their registration and verification processes with the new requirements. By noting the expanded recognition of authorities, shorter reporting timeframes, and updated documentation, stakeholders can prevent delays and ensure smooth access to the Malaysian market.
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