Malaysia Verification Route: Simplified Conformity Assessment Under Circular 1/2025

1. Key takeaways

The verification route allows a Conformity Assessment Body to assess a Class B, Class C or Class D device by verifying conformity evidence that has already been established elsewhere, rather than by conducting a full assessment. In Malaysia the route operates under Circular Letter of the MDA No. 1 Year 2025, which took effect on 11 March 2025 and revoked Circular 2/2014. The four assessment elements remain the same, namely QMS, PMS, TD and DoC, but the depth of examination changes: for Class C and Class D a full assessment normally involves a more comprehensive QMS audit, potentially with an on-site arrangement, and a stricter technical documentation review, whereas verification works from the existing evidence base. Official fees do not change with the route, standing at RM500 plus RM2,000 for Class C and RM750 plus RM3,000 for Class D.

• The route is available to Class B, Class C and Class D devices that hold an approval of a type recognised in the Circular.
• Circular Letter of the MDA No. 1 Year 2025 has been in force since 11 March 2025 and replaced Circular 2/2014.
• The four elements of QMS, PMS, TD and DoC are still assessed; what changes is that the CAB verifies existing evidence.
• Official fees remain RM500 plus RM2,000 for Class C and RM750 plus RM3,000 for Class D.
• Industry experience places a full Class C or D assessment at roughly six to twelve months and a verification-based file at roughly four to six months.
• MDA and CAB internal targets sit in the region of 30 working days each for verification-type review and MDA registration, subject to current commitments.
• The certificate presented must map to an approval type listed in Table 1 of the Circular; a certificate that cannot be mapped is rejected at the verification stage.

2. Legal basis

The operative instrument is Circular Letter of the MDA No. 1 Year 2025, effective 11 March 2025, which revoked Circular 2/2014 and restated the categories of foreign approval that qualify for verification. MDA/GD/0068 and MDA/GD/0070 set out the supporting guidance, and the MDA announcement titled Implementation of Circular Letter No. 1/2025, dated 26 March 2025, describes how the change is applied in practice. Circular 2/2014 Rev.5 Table 1 remains relevant as the historical version of the recognised country list, useful for understanding how a particular certificate was treated before the current circular took effect, but it is not the operative reference for a new submission. The four-element assessment structure itself comes from the Third Schedule to the Medical Device Regulations 2012. MDA/GL/MD-01 describes how the application is prepared and reviewed. The service reference of approximately 30 working days for each of verification-type review and MDA registration derives from the MDA CAB Guide for Conducting Conformity Assessment by Way of Verification issued in 2025, and it is a target rather than a statutory deadline.

3. Expert insights

The verification route is often described as a faster path, which is accurate but incomplete. It is faster because the CAB is testing whether an existing approval supports the Malaysian submission, not because the Malaysian requirements have been reduced. That distinction determines where projects fail. The most common failure is a certificate that does not correspond to a listed approval type in Table 1 of the Circular. A CE certificate, for example, must be identifiable by both its certificate type and the notified body number, so that it can be matched to a category such as MDD Annex II Section 3. Where that mapping cannot be made, the certificate will be sent back at the verification stage regardless of how strong the underlying technical file may be. The check is documentary and can be completed before any contract is signed.

The second point of failure is evidence that has not been localised. Verification accepts the technical basis of a foreign approval, but it does not accept foreign arrangements for classification, grouping, labelling language, the AR and establishment licence, or PMS. Those must be built to Malaysian requirements. Projects that treat verification as a translation exercise discover at review that the Malaysian-specific content is missing, and the resulting round consumes the time the route was supposed to save.

A third consideration is the interaction between verification and assessment depth for higher classes. Because Class C and Class D would otherwise attract a broader QMS audit and a stricter technical documentation review, the benefit of the route is greatest at those classes. At Class C and Class D, the verification route also changes the nature of the CAB conversation: the discussion centres on the scope and validity of the existing approval and on the completeness of the linkage to the Malaysian dossier, rather than on the design and manufacturing evidence itself. Preparing that linkage properly, with a clear statement of which foreign document supports which CSDT section, is what allows the CAB to complete its verification without opening a full technical enquiry.

4. Practical recommendations

• Confirm eligibility against Circular Letter No. 1/2025 before committing to the route, rather than assuming that any CE or FDA document qualifies.
• Record the certificate type and the notified body number for every CE certificate, and map each one to a Table 1 approval type in writing.
• Complete the certificate mapping check before signing with a CAB, since an unmappable certificate cannot be cured at the verification stage.
• Build the Malaysian-specific elements separately: classification, grouping, labelling language, AR and establishment licence, and PMS arrangements.
• Prepare a linkage table showing which foreign document supports each CSDT section, so that the CAB can verify rather than investigate.
• Plan against the four-stage structure of preparation, CAB assessment, MDA registration, and issuance and maintenance, and keep the five-year validity and renewal obligations in view from the start.
• Treat the 30 working day reference and the four to six month range as planning assumptions to be confirmed at submission, not as guarantees.

5. Verification checklist

• □ Circular Letter of the MDA No. 1 Year 2025, effective 11 March 2025 and revoking Circular 2/2014, has been reviewed in its current form.
• □ MDA/GD/0068 and MDA/GD/0070 have been checked for the evidence expected in a verification submission.
• □ The MDA announcement Implementation of Circular Letter No. 1/2025, dated 26 March 2025, has been reviewed for implementation detail.
• □ Circular 2/2014 Rev.5 Table 1 has been consulted only as the historical version of the recognised country list.
• □ Every certificate in the file is mapped to a Table 1 approval type, with certificate type and notified body number recorded.
• □ All timelines in the plan are labelled as industry experience or target reference rather than official commitments.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across Southeast Asia, including Malaysia. Our team prepares dossiers to ASEAN CSDT structure, manages submissions and deficiency responses with the MDA, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com