The Thai FDA regulates medical devices for a market of 70 million people. Thailand uses a Class I/II/III classification system — not the ASEAN A/B/C/D system — and the terminology can mislead teams familiar with US FDA classifications. Our database indexes 70,000+ records with normalized classification data.
Search Thailand registrations →Thailand's Food and Drug Administration — commonly written FDA-TH to distinguish it from the US FDA — is part of the Ministry of Public Health. It is the competent authority for medical device registration in Thailand under the Medical Device Act B.E. 2551 (2008), with subsequent amendments expanding its scope.
Thailand is a major healthcare market in Southeast Asia, with a well-developed private hospital sector and growing domestic manufacturing. It's also a regional hub for medical tourism, which creates strong demand for high-quality imported devices. The Thai FDA has been working toward ASEAN harmonization, though implementation has been uneven.
Thailand uses a three-class system: Class I (lowest risk), Class II (moderate risk), and Class III (highest risk). This is structurally similar to how the EU once classified devices and how several other systems work.
The important thing to understand: "Class III" in Thailand does not carry the same weight as "Class III" in the US FDA system. In the US, Class III typically means a device that requires a Premarket Approval (PMA) — think implantable cardiac devices, high-risk neurologicals. In Thailand, Class III is simply the highest of three tiers, and some devices that would be Class III in Thailand might be Class II in the US, or vice versa. Always verify classification independently for each market.
| Class | Risk Level | Examples | Review Timeline* |
|---|---|---|---|
| Class I | Low | Bandages, tongue depressors, non-powered examination equipment | Notification (no full review) |
| Class II | Moderate | Syringes, endoscopes, diagnostic ultrasound equipment | 90–180 days |
| Class III | High | Implantable pacemakers, coronary stents, HIV diagnostic kits | 180–360 days |
* Timelines are approximations for complete, compliant submissions. Class I devices are notified rather than reviewed. The FDA-TH has been working to reduce Class II/III timelines as part of ASEAN harmonization efforts.
Like Indonesia and Malaysia, Thailand requires a local authorized representative to hold device registrations. Foreign manufacturers cannot directly hold Thai FDA registrations. The local representative takes regulatory responsibility and must be a Thai-registered company with relevant licensing.
This means that the "manufacturer" field in FDA-TH registration data often shows the local representative rather than the OEM. We apply OEM inference where the relationship can be reliably identified, tagging inferred data clearly so you know what came directly from the registry versus what we derived.
Thai FDA registration numbers follow a format that typically includes a "G" prefix for general medical devices (as opposed to in vitro diagnostics, which use a different prefix), followed by the year and a sequential number. The format has evolved over time, and older registrations may use different conventions. When searching our database, you can look up devices by registration number if you have it, or by manufacturer name and device description.
Thailand is a member of ASEAN and has participated in harmonization discussions, but implementation of the ASEAN Medical Device Directive has been slower in Thailand than in some other markets. This means that while classification principles are broadly similar across ASEAN, the specific documentation requirements and review processes in Thailand remain distinct. Technical files acceptable to Singapore's HSA will need adaptation for the Thai FDA — they are not directly transferable.
Our Thailand dataset includes active and historical registrations with normalized classification labels, OEM inference where applicable, and manufacturer name normalization for cross-market research. You can search by:
70,000+ records. 50 free searches per month. No Thai-language government portal required.
70,000+ FDA-TH records, normalized and searchable alongside 7 other Asian markets. 50 free searches to start.