Malaysia: MDA Announcement Re: Medical Device Re-Registration Must Be Submitted One Year Before Expiry via MeDC@St 2.0+

The Medical Device Authority (MDA) reminds all licensed establishments of the official requirements for re-registering medical devices in Malaysia, in accordance with the latest Guidance Document MDA/GD/0070 titled “Guide for Medical Device Establishment Conformity Assessment by Way of Verification & Submission of Medical Device Registration in MeDC@St.”

Under this guidance, re-registration must be conducted via the MeDC@St 2.0+ system, which is now enhanced with stricter automation features.

To read more, refer to the official announcement and source document from MDA:

Announcement Update in PDF Format

Effectivity

The updated re-registration requirement is effective from June 5, 2025.

Key Highlights

1. System Access for Re-registration
   
   

   • The re-registration function becomes available exactly one (1) year before the current registration certificate expires.
   • Establishments are encouraged to initiate applications early to avoid last-minute issues.
     
     

2. Strict System Deactivation After Expiry
   
   

   • Upon expiry, the system will automatically deactivate the certificate.
     

Missed Re-registration Consequence

• If the registration lapses, the establishment must submit a new registration application.
• The device will then be subject to the full conformity assessment process, as per Act 737.

Proactive Compliance Urged

• Establishments are strongly advised to plan and manage re-registration and change notification activities well ahead of deadlines to prevent disruption in compliance or market access.

Revision History

• Initial Release: 17 May 2024
• Rev 2 (Current): 5 June 2025
  • Aligned with MDA/GD/0070 (March 2025 – First Edition)
  • Clarified that no re-registration can be submitted after expiry, even if a draft exists.

Implications to Clients

Failure to complete re-registration within the required timeframe will necessitate a new registration process, resulting in increased time, cost, and regulatory burden.

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