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MDMA Renewal & Change Notification

MDMA certificate validity​

The MDMA certificate is typically valid for one to three years, depending on device class and the history of the registration. Before expiry, the manufacturer (via AR) must submit a renewal application to maintain the device's registration status.

Renewal process​

MDMA renewal is submitted via GHAD:

  1. Submit the renewal application before the certificate expires
  2. Provide updated technical file sections (where changes have occurred)
  3. Submit updated PSUR / PMS data confirming continued safety and performance
  4. Pay the renewal fee
  5. SFDA reviews the renewal; updated MDMA certificate issued
MDMA-1 renewals → TFA required

Devices originally registered under the GHTF/MDMA-1 route must now follow the TFA pathway at renewal — a complete technical file is required. This is a significant additional burden for manufacturers who previously registered under the simplified GHTF route.

Change notification​

Manufacturers must notify the SFDA (via AR via GHAD) of significant changes to the device after MDMA approval. Significant changes typically include:

  • Changes to intended use or indications
  • Changes to design, materials, or manufacturing process that could affect safety or performance
  • New or changed labelling or IFU
  • Change of manufacturing site
  • Change of AR (requires MDMA update)

Minor changes (typo corrections, improved IFU clarity with no substantive change) may be managed through internal change control without SFDA notification — but the distinction between minor and major must be carefully assessed.

Major change → Re-submission​

Some significant changes require a new or supplementary MDMA application rather than a simple change notification. The SFDA will advise on whether a change triggers re-submission based on the nature and extent of the change.

Further reading​