Renewal filing window
approval.renewal-earliest-days-before-expiry
- DaysBeforeExpiry
90
- Direction
no-earlier-than
Thai FDA · structured requirements
🇹🇭 Thailand medical device regulatory data
Explore the medical device requirements currently available for Thailand, organized by topic and linked to official sources.
9 facts3 dimensions2 official sourceslatest verification 2026-08-24
Approval validity & renewal
What expires, what is retained periodically, and when must renewal start?
Fact-level verified
Renewal extension
approval.renewal-extension-years
- Years
5
Conditions
- Applies to the product authorization forms identified by the Thai FDA renewal FAQ.
Authorization duration
authorization.duration
- Type
Fixed Term
- Description
Medical-device licences/detailed-listing/listing authorizations renew for another 5 years.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Expiry or lapse consequence
authorization.lapse
After the permitted late period, renewal is unavailable and a new process is required.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Renewal or maintenance
authorization.renewal
Apply no more than 90 days before expiry.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Change control
Does the event require internal documentation, notice, prior approval, transfer, or a new application?
Change-control outcomes
change.available-outcomes
- Outcomes
- Notification Or Administrative Update
- Prior Approval Amendment Or Variation
- New Registration Or New Application
- Description
Product and establishment change services are separate; Full CSDT transfer has its own path.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Registration-dossier transfer package
change.registration-dossier-transfer
- ApplicationFormat
Full CSDT
- AdditionalDocuments
- declaration-of-identicality
- letter-of-consent
- safety-declaration
Transfer completion effect
change.transfer-completion
- MasterRegistrationCancelledAfterApproval
Yes
- FormerHolderClosureDeadlineDays
30
Economic-operator roles
Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?
Representative or holder change
market-entry.representative-change
- Path Code
Registration Dossier Transfer With Consent
- Fresh Registration
New Application Using Transferred Dossier
- Minimum Handover
- declaration of identicality
- consent to dossier transfer
- new manufacturer LoA
- registration dossier
- complaints/recalls
- Thai labels
- import inventory
- Notes
Transfer facilitates a new application; it is not merely editing the old holder field.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
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