MALAYSIA · MEDICAL DEVICES

Malaysia automated re-registration 2026: check CN, CAB and updatable documents first

Malaysia’s Medical Device Authority (MDA) has operated an Automated Re-Registration Route in MeDC@St 2.0+ since 13 July 2026. For manufacturers with existing registrations, preparation comes down to checking eligibility, clearing any reportable changes, then updating documents in the permitted fields and paying the fees. MDA issued Revision 2 of the guide with updated FAQs on 14 October 2026, so any procedure written only from the July version needs to be rechecked. (Source: MDA announcement and submission guide, Revision 2)

This article focuses on re-registration of Class B, C and D devices, including IVDs. Class A uses its own form in Part A of the guide, with different sections and no CAB section; assess it against those requirements rather than applying the CAB checklist below.

Which Class B, C and D devices qualify for automated re-registration?

For each registration number you plan to renew, check the MeDC@St record, registration certificate, establishment licence and CAB documents together. Section 2 of the guide sets out the general eligibility criteria below; if any item is unresolved, deal with it through the relevant procedure first. (Source: guide, Section 2)

The FAQs explain that there is no separate option labelled “Automated Re-Registration” in the system; the streamlined process is triggered by the eligibility criteria and the information in the application, and the required documents must still be submitted. There is no routine manual evaluation, but MDA reserves the right to request additional information or conduct further regulatory review where necessary.

For Class A, the Section 2 criteria are not split by risk class, yet the Class A form has no CAB section. The guide does not say how the original-route criterion applies to Class A, so confirm this with MDA before submitting.

Which updates need a CN before re-registration?

The fact that some form fields are open for update does not mean the approved device can be changed through re-registration. A matrix of actual changes, the approved fields they affect and the related CN status works better than uploading a new document set and explaining the differences afterwards. The table follows the October FAQs. (Source: guide FAQs, pp. 15–18)

For example, if a manufacturer renews its ISO 13485 certificate and moves production to a new site in the same year, that is not a validity-only update; the site change needs a CN first. Only a pure validity renewal can go straight into the re-registration application. Note also that a related CN cannot be submitted while the re-registration application is being processed, so schedule changes before or after it.

CAB certificate: valid at submission, and maintained afterwards

The October FAQs state that the CAB certificate must be valid before and at the time of submission, with no prescribed minimum remaining validity. If it has expired, the registration holder must provide an updated recertification certificate issued by a registered CAB directly in the application form; valid certificates and reports already on file do not need to be uploaded again. Registration holders remain responsible for keeping their devices’ conformity assessment status valid throughout the registration period. (Source: guide, “CAB Certificate & Conformity Assessment” FAQs, pp. 10–13)

Updates after re-registration also differ from older guidance. Given the interim nature of the route, MDA does not currently expect a CN solely to reflect a renewed CAB certificate for devices re-registered this way; the registration holder keeps the latest CAB certificate and report and provides them on request. This applies to CAB certificate renewal only; other changes still follow CN requirements, and timely recertification is still required. The guide adds that under MeDC@St 3.0, updated CAB certificates and Verification reports will be uploaded directly by the CAB through a “Change Management – Update for Re-Registration” pathway, with details to follow; the 3.0 core modules are targeted for December 2026.

The current system sends no automatic reminder when a CAB certificate is due to expire. We suggest the registration holder keeps a CAB expiry register and agrees document delivery dates with the manufacturer, rather than waiting for a platform notice.

COVID-19 test kits registered under the former CAB exemption need a separate check

MDA’s announcement of 26 June 2026 confirms that the CAB conformity assessment exemption for COVID-19 test kit registration no longer applies, following the withdrawal of the relevant circular letter on 23 February 2024. Applications must now meet current registration requirements and include a valid CAB Conformity Assessment Report and Certificate of Conformity; kits already in MeDC@St may be re-registered through their existing registration record. (Source: MDA announcement on COVID-19 test kit re-registration)

So this is not a routine CAB recertification, and holding any foreign certificate does not automatically satisfy the Verification conditions. The announcement does not list which approvals qualify; that should be assessed under MDA’s current Verification guidance.

For these kits, the AR and the CAB should first confirm the usable reference approval, product equivalence and the reports required, and only then settle the re-registration route. The announcement does not mention the automated route, and automated re-registration requires original registration via Full Conformity Assessment or Verification, so do not assume that previously exempted kits can go straight into it.

Plan re-registration by registration number and payment milestone

We suggest building a register of registration numbers expiring within the next year, showing CN/COO, CAB, QMS and product version status, and scheduling prerequisite items ahead of re-registration. For items with no pending changes, prepare the applicable clinical or performance evaluation, risk, post-market and declaration documents together. This sequence is a project-management suggestion; statutory and system windows follow the actual rules.

The application fee and registration fee are issued as two separate invoices: the registration fee invoice is generated only after the application fee is paid and the application passes system validation, and the certificate is issued only after the registration fee is paid. The registration number stays the same, and the new validity runs on from the previous expiry date provided the application fee is paid before the existing certificate expires. The FAQs set no fixed regulatory or operational processing timeline. Fee rates are listed on page 20 of the guide, under the Fifth Schedule of the Medical Device Regulations 2012 as amended in 2025. (Source: guide, “Fees, Timeline and Registration Certificate”, p. 20)