Two Updates from Malaysia MDA: Automated Re-Registration Route and Hologram Security Label

By Yu Seen Ng and Megan Gottlieb

Background on MDA registration renewals 

In Malaysia, Registration Certificates issued by the Medical Device Authority (MDA) are valid for five years and are subject to renewal, known as re-registration. Class B, C and D device Conformity Assessment Body (CAB) certificates are also valid for five years and must be reissued. The recertification assessment for the CAB certificate must be completed ahead of the re-registration application submission.

To complete the re-registration, the manufacturer or an Authorized Representative (AR) based in Malaysia must submit an application via the online portal, MeDC@St 2.0+, up to one year prior to the expiration of the registration. Once all conditions and payments have been satisfied, the MDA will issue a renewed Registration Certificate. The typical turnaround time for a re-registration application by the MDA, and re-certification by the CAB when applicable is three to five months.

New Automated Re-Registration Route

The MDA announced a new Automated Re-Registration Route as of July 13, 2026. Renewal applications submitted on or after July 13 may now use this, while applications submitted before July 13 must continue with the previous evaluation route.

While the Automated Re-Registration Route is in the very early stages of implementation, Emergo by UL’s experience thus far suggests that the route may significantly shorten MDA processing times for eligible renewal applications.

The documentation required for re-registration submission includes the current Quality Management System (QMS) certificate, pre-market approval, latest labeling, updated post-market surveillance (PMS) and vigilance information for the preceding five-year registration period, and an updated Declaration of Conformity (DoC). For Class B, C and D devices, an updated Clinical Evaluation Report (CER) and a valid CAB certificate are also required.

Once the required documentation has been submitted and the application fee has been paid, no further review by the MDA is required. The system will then automatically prompt the applicant for payment of the registration fee. Upon receipt of the registration fee, the Registration Certificate will be issued.

Prior to submission of the application, there must be no active change applications for the device. The announcement includes additional information on the eligibility, requirements and scope of the Automated Re-Registration Route, along with a process flowchart and 13 FAQs.

Background on Hologram Security Labels in Malaysia

The Ministry of Health Malaysia (MOH) originally introduced the Farmatag Hologram Security Label for pharmaceutical products in 2005. This measure was introduced to help combat counterfeit products in the market and serves as the foundation for extending this initiative to medical devices.

Hologram Security Labels for medical devices 

The MDA recently announced the implementation of the Hologram Security Label for registered medical devices, which will be required in phases. The Hologram Security Label will help consumers and healthcare professionals verify that a medical device has been registered with the MDA.

Little detail is offered in the MDA press release, but additional information may be provided by the MOH during the International Medical Device Exhibition and Conference (IMDEC) 2026 on Aug. 26, 2026.

Concluding remarks

The MDA continues to introduce measures intended to reduce regulatory burden for manufacturers while supporting the safety and traceability of medical products. 

The Automated Re-Registration Route represents a simplification of the renewal process for devices that will remain on the market beyond the initial five-year validity period. 

While more information is still needed regarding the MOH implementation of Hologram Security Labels for medical devices, stakeholders have now been notified, and Emergo by UL will continue to monitor developments related to the program.