The Medical Device Authority (MDA) has officially announced the introduction of the Automated Re-Registration Route within the MeDC@St 2.0+ platform. Effective 13 July 2026, re-registration applications submitted on or after this date will be eligible for the automated pathway, while applications submitted before the effective date will continue to follow the existing evaluation process.

The official announcement also serves as an operational user guide, outlining the eligibility requirements, implementation scope, and application form modifications required for the new re-registration route.

Introduction to the Automated Re-Registration Route
The Automated Re-Registration Route in MeDC@St 2.0+ enables eligible registration holders to renew their medical device registrations through an optimized and automated submission process.

This route applies only to medical devices that meet the eligibility criteria specified under the Medical Device Act 2012 (Act 737), its subsidiary regulations, relevant MDA guidance documents, and the requirements outlined in the official announcement.

Eligibility and General Requirements
To qualify for the Automated Re-Registration Route, registration holders must ensure they meet the following eligibility requirements before initiating an application:

1. The establishment must hold a valid Manufacturer Licence or Authorized Representative (AR) Licence.
2. There must be no active Change Notification (CN) or Change of Ownership (COO) applications for the device in MeDC@St 2.0+.
3. The current medical device registration certificate must remain active and be within one (1) year prior to its expiration date.
4. The device must have been previously registered through either the Full Conformity Assessment or the Verification pathway, and the corresponding Conformity Assessment Body (CAB) certificate must remain valid.
5. All registration data must reflect the latest information approved by the MDA. Unapproved changes are not permitted unless explicitly specified in the announcement.
6. The medical device registration certificate must not be subject to any active rejection, suspension, or cancellation status.

The guide also states that it should be read together with the current edition of MDA/GD/0070 – Medical Device Registration Submission Guide for Conformity Assessment by Way of Verification Process and Submission of Application in MeDC@St.

Implementation Scope
The submission requirements differ depending on the classification of the medical device. The official guide provides separate application form requirements for:

1. Class A Medical Devices
2. Class B, Class C, and Class D Medical Devices

For each device classification, the guide outlines which sections of the application form are system-generated and non-editable, as well as the sections that require updates and supporting documentation during the re-registration process. These requirements should be read together with the relevant annexes in MDA/GD/0070.

Important Notes
The MDA emphasizes that changes or updates to registered medical device information are not permitted during the re-registration process, except for the sections specifically identified in the announcement or within MDA/GD/0070.
Any other changes must first be approved through the Change Notification (CN) pathway before initiating the automated re-registration application. The MDA also reserves the right to request additional information or conduct further regulatory review where deemed necessary.

Conclusion
The introduction of the Automated Re-Registration Route marks an important update to Malaysia’s medical device regulatory process. Effective 13 July 2026, eligible registration holders may submit their re-registration applications through the automated pathway, provided they meet the eligibility requirements and submission conditions outlined by the MDA.

Registration holders are encouraged to review the official guidance carefully and ensure that all applicable requirements are met before submitting their applications through MeDC@St 2.0+.

How Tecolab Can Help
Navigating medical device re-registration can be challenging, especially when ensuring compliance with the latest MDA requirements. Tecolab provides expert regulatory support to help manufacturers and Authorized Representatives prepare complete and compliant submissions.

Our services include:

1. Medical device registration and re-registration

2. Regulatory documentation review

3. Change Notification (CN) support

4. Guidance on MeDC@St 2.0+ submissions

Need assistance with your medical device registration or re-registration? Contact us today to speak with our regulatory experts.