On September 12, 2025, the Medical Device Authority (MDA) of Malaysia released the Second Edition of Guidance Document MDA/GD/0068: Conformity Assessment Body (CAB) Guide for Conducting Conformity Assessment by Way of Verification. This update aims to improve consistency, transparency, and efficiency of conformity assessments under Malaysia’s medical device regulatory framework.
Scope
Guidance document detailing instructions for Conformity Assessment Bodies (CABs) on conducting conformity assessments by way of verification.
Key Highlights
- Added Singapore and Thailand as recognised regulatory authorities in Appendix 1.
- Schemes or programs not subject to verification pathways now explicitly include Singapore and Thailand in Table 2.
- Verification criteria for conformity assessment of Class B, C, and D devices during initial certification and recertification in Appendix 2:
- Include evidence of pre-market clearance or approval from Singapore
- Conformity Assessment Report for medical and IVD devices (verification of evidence for initial certification) in Appendix 3:
- Include evidence of pre-market clearance or approval from Singapore and Thailand under recognized regulatory authorities or notified bodies
- 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.
- Changed from ‘Yes/No’ to ‘Provide summary/conclusion’ on clinical safety, efficacy, and risk/benefit in Section 7: Technical Documentation Assessment
- Conformity Assessment Report for medical and IVD devices (verification of evidence for FOR RECERTIFICATION ASSESSMENT) in Appendix 5:
- 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.
- Changed from ‘Yes/No’ to ‘Provide summary/conclusion’ on clinical safety, efficacy, and risk/benefit in Section 7: Technical Documentation Assessment.
- 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 ‘has been marketed for at least one year in the respective agencies’ jurisdictions; and’ under Verification (initial certification assessment) | 8 September 2025 | ||
2 | Table 2 : Schemes/ programs exempt from verification pathway for medical device | Added schemes or programs not subject to verification pathways for Singapore and Thailand | ||||
3 | APPENDIX 1 (normative) | Added Singapore and Thailand as recognized regulatory authorities | ||||
RECOGNIZED REGULATORY AUTHORITIES OR NOTIFIED BODIES | ||||||
4 | APPENDIX 2 (informative) | Added in: | ||||
CONFORMITY ASSESSMENT ELEMENTS REVIEW AND VERIFICATION CRITERIA FOR CONFORMITY ASSESSMENT BY WAY OF VERIFICATION PROCESS FOR CLASS B, C AND D INITIAL CERTIFICATION AND RECERTIFICATION ASSESSMENT | evidence of pre-market clearance or approval for Singapore and Thailand under RECOGNISED REGULATORY AUTHORITY OR NOTIFIED BODY DETAILS. MDSAP under QMS certificate information in CONFORMITY ASSESSMENT ON QUALITY MANAGEMENT SYSTEM Editorial changes from CER to CPR under Clinical performance for in-vitro medical devices | |||||
5 | APPENDIX 3 | Added in | ||||
CONFORMITY ASSESSMENT REPORT FOR MEDICAL DEVICES INCLUDING IN-VITRO DIAGNOSTIC DEVICES (by way of verification on evidence of conformity) | evidence of pre-market clearance or approval for Singapore and Thailand under RECOGNISED REGULATORY AUTHORITY OR NOTIFIED BODY DETAILS. Removed ‘to 5 years’ from Post | |||||
FOR INITIAL CERTIFICATION ASSESSMENT | market surveillance & vigilance report for the past 3 to 5 years under SECTION 6: CONFORMITY ASSESSMENT ON POST MARKET SYSTEM. Rephrased from ‘yes or no’ to ‘provide summary/conclusion’ under Summary/conclusion of the overall assessment on the clinical safety and efficacy, risk/benefit assessment: in SECTION 7: CONFORMITY ASSESSMENT ON TECHNICAL DOCUMENTATION | |||||
6 | Second | APPENDIX 5 CONFORMITY ASSESSMENT REPORT FOR MEDICAL DEVICES INCLUDING IN-VITRO DIAGNOSTIC DEVICES (by way of verification on evidence of conformity) FOR RECERTIFICATION ASSESSMENT | Removed ‘to 5 years’ from Post market surveillance & vigilance report for the past 3 to 5 years under SECTION 6: CONFORMITY ASSESSMENT ON POST MARKET SYSTEM. Rephrased from ‘yes or no’ to ‘provide summary/conclusion’ under Summary/conclusion of the overall assessment on the clinical safety and efficacy, risk/benefit assessment: in SECTION 7: CONFORMITY ASSESSMENT ON TECHNICAL DOCUMENTATION | |||
Attachment
See the full guidance here: Second Edition Guidance Document MDA/GD/0068 (official MDA source).
Effective Date
12 September 2025
Implications to the Client
- CABs will strictly implement the updated timelines, documentation, and reporting structures in line with the new edition
- Manufacturers/Authorized Representatives should ensure conformity assessment submissions align with the revised requirements, and anticipate stricter conformity assessment procedures
- Non-compliance with the updated procedures could lead to delays or rejections in medical device registration applications.
For guidance on aligning your device registration with the Second Edition of MDA/GD/0068, please contact us at sales@andamanmed.com or click the button below.
