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Renewal & Maintenance

5-year validity for all approval types · Renewal mandatory

5-Year Approval Renewal​

All Thai FDA product approvals (Listing, Notification, License) expire after 5 years from the date of issue. Renewal is mandatory — there is no automatic extension.

Renewal Process​

  1. Submit renewal application via Thai FDA e-submission system at least 3–6 months before expiry
  2. Provide updated ISO 13485 certificate (must be current)
  3. Confirm Establishment License is still valid
  4. Declare any changes to the device during the 5-year period:
    • If significant changes occurred: a variation notification may be required first
  5. Thai FDA reviews renewal application
  6. Updated approval certificate issued for a further 5-year period

Consequences of Lapsed Approval​

A lapsed approval means the device cannot legally be distributed or imported in Thailand until renewal is achieved. Track expiry dates rigorously — set calendar reminders at 12 months, 6 months, and 3 months before expiry.

Product Variation Notifications​

During the 5-year approval period, notify Thai FDA of significant changes:

Change TypeNotification Needed
Device design, materials, or specifications✅ Yes
Change in intended purpose or indication✅ Yes
Manufacturing site change✅ Yes
Significant labelling change✅ Yes
New model added to existing group✅ Yes (variation)
Administrative changes (address, company name)✅ Yes
Minor labelling changes (no safety impact)May be a minor variation — confirm

Submit a variation application with supporting evidence that the change does not compromise device safety or performance.

Transfer of License Holder​

If the Thai AR or license holder changes:

  1. Submit a licence transfer application to Thai FDA
  2. Both outgoing and incoming entities must cooperate
  3. Incoming entity assumes all post-market obligations
  4. Ensure Establishment License of incoming entity is valid before transfer
  5. Plan the transfer to avoid any gap in valid product approval

Cancellation of Registration​

An approval may be voluntarily cancelled (product withdrawn from market) or cancelled by Thai FDA due to:

  • Safety concerns
  • Persistent non-compliance
  • Failure to renew
  • Submission of fraudulent documentation

Before cancelling a registration voluntarily, ensure all distributed devices are accounted for and consider whether any post-market actions (FSCAs) are needed.