Who Needs to Comply?

Thai Manufacturers

Thai manufacturers of Class 1–4 medical devices must:

Obtain an Establishment License from Thai FDA (mandatory for all manufacturers)
Register all Class 2, 3, and 4 devices before market placement
List Class 1 Positive List devices via the Listing pathway
Maintain ISO 13485 QMS aligned with the device class
Comply with labelling, post-market, and renewal requirements

All commercial importers of medical devices into Thailand must:

Obtain an Establishment License as an importer (mandatory — separate from product approval)
Import only devices that hold valid Thai FDA Listing, Notification, or License
Ensure devices comply with Thai labelling requirements before distribution
Maintain distribution records and cooperate with Thai FDA inspections

Foreign manufacturers who place devices on the Thai market must appoint a Thai Authorized Representative (AR):

The AR must be a Thai-registered entity or individual
The AR acts as the regulatory contact for Thai FDA on behalf of the foreign manufacturer
Under the Thai model, a single manufacturer may appoint multiple importers and distributors — the AR coordinates regulatory responsibilities, while different commercial entities may handle physical importation in different product areas
The AR holds the product approval (Listing/Notification/License) or supports the license holder's application

The license holder (the entity holding the Notification or License) carries ongoing post-market obligations:

Stage	Action
1	Classify device (Class 1–4, ASEAN AMDD rules)
2	Obtain Establishment License (manufacturer or importer)
3	For wireless devices: initiate NBTC review in parallel
4	Prepare CSDT dossier (Class 2–4) or Listing form (Class 1)
5	Submit via Thai FDA e-submission system
6	Thai FDA review and approval (Listing/Notification/License)
7	Commercially distribute in Thailand
8	Post-market: vigilance, label compliance, renewal
9	Renew approval before 5-year expiry