The Medical Device Authority (MDA) of Malaysia has officially introduced the new Automated Re-registration Route through the MeDC@St 2.0+ system. The new route will be effective on 13 July 2026. This new automated re-registration route allows eligible registration holders to renew their medical device registration through an automated assessment process.
What is the Automated Re-Registration Route
The Automated Re-Registration Route is a streamlined re-registration pathway within the MeDC@St 2.0+ platform that allows eligible registration holders to renew their medical device registrations automatically, without undergoing the standard evaluation route.
Eligibility Criteria for Automated Re-Registration
The Automated Re-Registration Route is applicable to registered medical devices across all device classes (Class A, B, C, and D). However, the applicant must meet and comply with several criteria in order to be eligible for the automated route. These criteria include:
- 1) Manufacturer or Authorized Representative (AR) hold valid Establishment License
- 2) No pending Change Notification (CN) or Change of Ownership (COO) application in MeDC@St 2.0.
- 3) Current registration certificate is still valid and expires within one (1) year.
- 4) The medical device was previously registered through the Full Conformity Assessment or Verification pathway, and the CAB certificate is still valid.
- 5) All medical device registration information must be current and approved by the MDA
- 6) The registration certificate must be active and not rejected, suspended, or cancelled.
Implementation Scope and Requirements by Device Class
To assist applicants in understanding the Automated Re-Registration process, Table 1 below provides a simplified summary of the information that may or may not be editable in MeDC@St 2.0+ during the re-registration process according to device class.
| No. | MeDC@St 2.0+ Application Form Section Name | Re-Registration Requirement Class A |
Re-Registration Requirement Class B, C, D |
| 1 | Medical Device Classification | Non-editable | Non-editable |
| 2 | Product Status Determination | Non-editable | NA |
| 3 | Medical Device General Information | Non-editable | Update Required (Certain Fields) |
| 4 | Medical Device Grouping | Non-editable | Non-editable |
| 5 | Common Submission Dossier Template (CSDT) | NA | Update Required (Certain Fields) |
| 6 | Additional Requirements | Update Required | NA |
| 7 | Manufacturer Information | Update Required | Update Required |
| 8 | Pre-Market Clearance / Approval | Update Required | Update Required |
| 9 | Conformity Assessment Body (CAB) | NA | Update Required / Non-editable |
| 10 | Labelling | Update Required | NA |
| 11 | Post-Market Surveillance (PMS) & Vigilance | Update Required | Update Required |
| 12 | Declaration of Conformity (DoC) | Update Required | Update Required |
Table 1: Summary of the information that may or may not be editable MeDC@St 2.0+
Note:
- NA: Not Applicable (section does not exist for the respective class)
- Update Required / Non-editable: Update Required for expired CAB certificates; non-editable for valid existing CAB certificates.
- Any other changes/updates to the registered medical device information is prohibited during the re-registration unless has been approved via CN prior to initiating the automated re-registration application.
The announcement also serves as an operational user guideline, providing comprehensive step-by-step instruction details to assist applicants in navigating the Automated Re-Registration process within MeDC@St 2.0+. Applicants are encouraged to carefully read and understand this guideline carefully, as it shall be read in conjunction 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.
Automated Re-Registration Process Flow
The automated re-registration process consists of several key steps, starting from eligibility checking until the issuance of the renewed registration certificate. A simplified process flow is illustrated in Figure 1.
Application and Registration Payment Fee
Applicants are also required to pay the applicable application and registration fees for Automated Re-Registration in accordance with the existing standard fee structure established by MDA as shown in the Table 2 below:
| Medical Device Class | Application Fee (RM) | Registration Fee (RM) |
| A | 500 | 750 |
| B | 250 | 1000 |
| C | 500 | 2000 |
| D | 750 | 3000 |
Table 2: Payment Fee structure
Planning your Malaysia medical device re-registration? Qualtech can support your team in assessing eligibility for the Automated Re-Registration Route in MeDC@St 2.0+, reviewing registration status and required documentation, and preparing the re-registration application in line with MDA requirements.
Contact us to plan your re-registration early and support continuous market access in Malaysia!
Clarification through Visuals
Figure 1: Overview Automated Re-Registration Flowchart