The Medical Device Authority (MDA) Malaysia has released an important reminder to all licensed establishments regarding re-registration procedures for medical devices under the MeDC@St 2.0+ system. As part of ongoing digital transformation and enforcement enhancements, MDA now enforces strict re-registration timing to ensure uninterrupted regulatory compliance and market access.
Key Timeline: 1 Year Before Expiry
Establishments may begin submitting re-registration applications exactly one (1) year before the certificate’s expiration date via the MeDC@St 2.0+ online system. Failure to submit the application before the certificate expires will permanently disable the ability to re-register under the same certificate.
What Happens If You Miss the Deadline?
If the certificate expires before submission:
- System will automatically deactivate the registration.
- Even draft applications saved before the expiry date cannot be submitted.
- Establishments must restart the process via a new registration, subject to the full conformity assessment process under Medical Device Act 2012 (Act 737).
How to Stay Compliant
To avoid disruptions:
- Set reminders aligned with your certificate expiration date.
- Begin preparing re-registration documentation well in advance.
- Ensure your change notification and conformity assessments are up to date before reapplying.
This process is detailed in the MDA Guidance Document No. MDA/GD/0070 (March 2025 – First Edition), which serves as the current reference for conformity assessment by verification.
MDA appreciates the industry’s continued cooperation in upholding the safety and availability of medical devices in Malaysia through timely regulatory action.
Official Source: Submission of Medical Device Re-Registration Applications
Published by MDA on 5 June 2025
