The Medical Device Authority (MDA) Malaysia has officially introduced the Automated Re-Registration Route within the MeDC@St 2.0+ platform.
Effective 13 July 2026, eligible re-registration applications will transition to this automated pathway, significantly reducing regulatory processing times and streamlining market access while ensuring compliance with the Medical Device Act 2012 (Act 737), applicable regulations, and MDA guidance documents.
The announcement also serves as the operational user guide detailing eligibility criteria, application requirements, and form updates for Class A, B, C, and D medical devices.
Read the full announcement here:
https://portal.mda.gov.my/index.php/announcement/1821-official-announcement-and-submission-subject-introduction-of-the-automated-re-registration-route-in-medc-st-2-0-for-streamlined-market-access-and-continuous-supply-of-medical-devices
Key Highlights
Implementation Timeline
The automated route applies strictly to eligible applications submitted on or after 13 July 2026.
Applications submitted prior to this date will continue to be processed under the standard evaluation framework.
Strict Eligibility Criteria
To qualify for the automated pathway, establishments must satisfy the following conditions:
- Must hold a valid Manufacturer or Authorized Representative (AR) license
- The current device registration must be active and within one (1) year of its expiration date
- The device must have been previously registered via either the Full Conformity Assessment or the Verification pathway, and the corresponding CAB certificate must remain valid
- The device registration certificate must be in good standing and must not be subject to any active registration rejection, suspension, or cancellation status
- There must be no pending Change Notification (CN) or Change of Ownership (COO) applications tied to the device
- All registration data must reflect the latest information approved by MDA. Unapproved changes are strictly prohibited
Implementation Scope and Form Requirements
The automated re-registration framework enforces a strict data structure depending on device classification.
Class A Devices
For Class A devices under Part A, core administrative sections such as classification, grouping, and general information are completely non-editable and system-generated.
Applicants are only required to upload updated, valid compliance documents, including:
- Current QMS certificates
- Localized labelling
- Recent Post-Market Surveillance (PMS) records
- Updated Declaration of Conformity (DoC)
Class B, C, and D Devices
For Class B, C, and D devices under Part B, foundational fields such as device grouping remain locked.
Updates are permitted only within highly specific fields under:
- General Information
- Common Submission Dossier Template (CSDT), such as updated Clinical Evaluation / Performance Reports
- Valid QMS certificates
- Active CAB status if an old certificate has expired
For the exact field-by-field breakdown, specific lists of accepted QMS types, and detailed documentation annexes for both pathways, applicants should refer directly to pages 2 to 5 of the announcement, which also serves as the operational user guide.
Modifications Prohibited
Any changes or updates to registered medical device information outside the narrow fields explicitly permitted in the guide are strictly prohibited during the re-registration process.
Any other product changes must be approved via the standard Change Notification (CN) pathway before initiating the automated re-registration application.
Authority Right
MDA explicitly reserves the right to request additional information or conduct further regulatory review where deemed necessary.
Implications to Clients
Medical device manufacturers and Authorized Representatives may benefit from a more efficient and predictable re-registration process, potentially reducing administrative burden and supporting uninterrupted market access.
Companies should review existing registrations in advance to ensure they satisfy all eligibility requirements and prepare the required updated documentation, including valid QMS certificates, labelling, PMS records, and Declarations of Conformity.
Organizations planning product updates should note that only limited information may be amended during automated re-registration. Other product changes must be approved through the Change Notification process before initiating re-registration.
Businesses should update their internal regulatory procedures and renewal timelines to align with the new automated process and documentation requirements.
Effective Date
13 July 2026
For Inquiries
For inquiries or support regarding medical device regulatory requirements in Malaysia, please contact sales@andamanmed.com.