The MDA verification route, for devices already approved abroad.

What the verification route is.

Section 7 of Act 737 requires every Class B, C and D device to pass conformity assessment by a registered CAB before MDA registers it. For a device already approved by a regulator MDA recognises, that assessment can be done by way of verification: the CAB verifies the evidence behind the existing approval rather than repeating it. The policy is MDA Circular Letter No. 2 of 2025 (30 September 2025, which revoked Circular No. 1 of 2025). The CAB works to MDA/GD/0068 and the applicant to MDA/GD/0070, both Second Editions, with GD/0070 last revised on 13 October 2025. Class A devices skip the CAB altogether under the Exemption Order 2024; see Class A registration.

The route shortens conformity assessment only. A foreign manufacturer still needs a licensed Malaysian authorised representative, and the registration is still made in MeDC@St and lasts 5 years.

Who qualifies (MDA/GD/0070, Table 1)

The Second Editions dropped an earlier condition that the device had been marketed for at least one year in the approving jurisdiction.

Which approvals count (MDA/GD/0070 Annex 1)

HSA and Thai FDA were added in the Second Editions. The HSA arrangement has its own history and published timings; see the Singapore HSA verification route. China’s NMPA is not on the list; its approvals counted only in the 2025 pilot described in Malaysia–China reliance.

EU certificates: which annexes match which Malaysian class

Only notified-body certificates are listed. A device that is self-declared in the EU, such as an EU Class I device that is Class B in Malaysia, has no EU approval to verify and needs another recognised approval or full conformity assessment. Classify the device under the Malaysian rules first; our classification guide covers the First Schedule.

Approvals that do not count (MDA/GD/0070, Table 2)

Special authorisations that let an unapproved device into a market for emergency or compassionate use are excluded, including but not limited to:

• US FDA: Emergency Use Authorization (EUA), Expanded Access (emergency or compassionate use), Humanitarian Device Exemption (HDE)
• EU national competent authorities and UK MHRA: exceptional use authorisations
• Health Canada: Special Access Program; Interim Orders (COVID-19)
• Japan PMDA: Compassionate Use System; emergency regulatory pathway (COVID-19)
• Australia TGA: Special Access Scheme, Authorised Prescriber Scheme, emergency exemptions (COVID-19)
• Singapore HSA: Special Access Routes
• Thai FDA: exemptions for non-commercial manufacture or import under section 27 of Thailand’s Medical Device Act

MDA’s own equivalent, special access, is likewise an exemption from registration, not a route to it.

What the CAB does (MDA/GD/0068)

• Who can verify. Any CAB registered under Act 737 with at least one Medical Device Technical Area in its scope; that scope lets it verify devices in any technical area. A Malaysian subsidiary of the foreign notified body may verify the same device, provided it keeps separate personnel and impartiality declarations.
• What it verifies. All four conformity assessment elements: the quality management system, the post-market surveillance system, the technical documentation and the Declaration of Conformity, against the checklist in Appendix 2.
• The foreign approval. Authenticity and validity, checked against the ARTG, Health Canada, FDA and SMDR databases where they exist.
• Effort. MDA recommends 4 hours of review per device application.
• Certificate. One conformity assessment procedure per certificate, issued to one manufacturer or authorised representative, whose name and address must match the establishment licence. It is signed by the technical personnel who did the verification and is valid for 5 years.

CAB turnaround (MDA/GD/0068 Table 3; MDA/GD/0070 Annex 2)

CAB fees are commercial; MDA sets none. Our all-in registration fees include the CAB fee and are on the pricing page.

What goes into MeDC@St (MDA/GD/0070 Annex 4)

Documents must be in English or Bahasa Malaysia, complete, legible, valid, signed and dated, and the same dossier the CAB reviewed goes into MeDC@St. The dossier format is on our CSDT page.

MDA review and deadlines

• Review time: 30 working days for Class B, C and D once documents are complete and payment has cleared (MDA/GD/0070 section 6.4). The full sequence is on our registration timeline page.
• Queries: answer each one in writing in MeDC@St. Information MDA requests must arrive within 90 working days or the application is rejected and the fee is not refunded; you may apply again.
• Refusal: MDA will not register a device that is not a medical device, is wrongly classified, lacks mandatory information within 30 working days, fails the Act, Regulations or guidance, or whose establishment licence has been revoked.

The routes compared

Points to watch

• Same device, same claims. The intended use in MeDC@St must match the intended use approved abroad, and the brand name must appear on the label, the DoC and the technical documentation.
• A cancelled foreign approval sends the device to full conformity assessment.
• MDSAP helps the QMS section, not the route. Since 25 September 2025 MDA accepts MDSAP reports and certificates from MDSAP-recognised auditing organisations as QMS evidence for foreign manufacturers, but an MDSAP certificate is not an approval in Annex 1.
• Outdated standards in the essential principles checklist need a gap assessment, and every non-applicable principle needs a rationale.
• Circular numbers. The guidance documents still cite Circular No. 2 of 2014 and No. 1 of 2025; the current policy is Circular No. 2 of 2025, which revoked No. 1 of 2025 on 30 September 2025.
• Fees. MDA’s registration fees are set by the Fifth Schedule of the Regulations as amended from 1 January 2026; the fee table printed in MDA/GD/0070 does not reflect every current figure, so use our cost guide.