Re-Registration Submission Timeline and Platform Requirement

An application of medical device re-registration shall be submitted through the upgraded MeDC@St 2.0+ online system before the expiration date as outlined in the Medical Device Guidance Document titled: Guide for Medical Device Establishment – Conformity Assessment by Way of Verification & Submission of Medical Device Registration (MDA/GD/0070, March 2025 – First Edition) in MeDC@St.

As part of efforts to strengthen regulatory enforcement and system automation, the re-registration function will be made available one year before the expiration date of the certificate. Once the certificate expires, the system will automatically deactivate the expired device registration certificates. After certificate deactivation, any re-registration application submission will no longer be permitted, including any draft applications that were created prior to the certificate expiry date but not submitted.

Implications of Missed Re-Registration and Compliance Recommendation

In such cases, the establishment is required to submit a new registration application which will be subject to the full conformity assessment process under the Medical Device Act 2012 (Act 737).

Therefore, establishments are strongly advised to strategically plan and manage their re-registration applications and change notification activities in advance to prevent any regulatory compliance issues or interruptions in market access.

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