Thailand Medical Device Registration (Thai FDA)

Thailand Authorized Representative & Medical Device Registration

Thailand Medical Device Registration Overview: This page covers the regulatory authority, device classification, registration process, local representative requirements and FAQs for medical device registration in Thailand. Medical devices in Thailand are regulated by the Medical Device Control Division (MDCD) of the Thai Food and Drug Administration (Thai FDA), and EVERBIZ can support you through the entire process from classification to registration.

1. Regulatory Framework

Medical devices in Thailand are regulated by the Medical Device Control Division (MDCD) of the Food and Drug Administration (Thai FDA). The main legal basis is the Medical Device Act B.E. 2551 (2008) and its 2019 amendment (B.E. 2562). Thailand’s classification and submission system is aligned with the ASEAN Medical Device Directive (AMDD).

All submissions are made through the SKYNET e-submission system.

2. Risk Classification and Registration Routes

Thailand uses four risk classes mapped to three submission routes:

Class Risk Submission route Notes
Class 1 Low Listing Automatic approval (for “positive list” products since January 2025)
Class 2 Low–moderate Notification CSDT required
Class 3 Moderate–high Notification CSDT required
Class 4 High Licensing Full CSDT required, with expert review

3. Core Submission Documents

  • CSDT technical dossier (ASEAN common submission template): product description, design and manufacturing, risk management, performance verification, clinical evidence

  • ISO 13485 certificate (at manufacturing-site level, also applicable to OEMs)

  • Certificate of Free Sale (CFS) from the country of origin, or certificate of origin

  • Thai / English labeling and IFU (Thai required for home-use devices)

  • Sterile or measuring Class 1 products: test reports required

4. Local Representative and Company Licensing

  • Foreign manufacturers must appoint a Thai Local Authorized Representative (LAR) holding an Establishment License

  • The LAR is the legal contact with the Thai FDA and is responsible for submissions, changes and vigilance reporting

  • Manufacturers or importers must obtain an Establishment License before submitting products

5. Expedited Review Routes

Eligible products can use simplified routes to shorten timelines:

  • Abridged Route – approved by the US FDA, an EU Notified Body, TGA, PMDA, Health Canada or WHO PQ for at least one year; some technical documents may be waived

  • Reliance Route – approved by Singapore’s HSA with an identical dossier; expert review can be waived, saving about 3 months

6. Registration Timelines

Class Estimated timeline
Class 1 (Listing) Automatic approval / 1–8 days
Class 2 / 3 (Notification) 4–10 months (up to 250 days)
Class 4 (Licensing) 10–14 months (up to 300 days)

Registration certificates are valid for 5 years.

7. Post-Market Obligations

  • Vigilance and adverse event reporting: both domestic and overseas events must be reported to the Thai FDA

  • Annual PMS report: submitted every year

  • Sales and distribution records: kept for at least 5 years

  • Renewal: since 22 July 2025, Class 2–4 registrations must be renewed via SKYNET between 1 October and 31 December each year (starting with certificates expiring on 31 December 2025)

  • UDI: draft published in March 2025; to be phased in for Class 2–4 with a 2-year transition period

8. Recent Key Changes

  • January 2025: automatic approval introduced for Class 1; “positive list” products receive a number upon submission

  • March 2025: updated labeling and IFU requirements (Notification B.E. 2568); UDI draft published

  • July 2025: renewal system formally established, with annual renewal for Class 2–4

  • Ongoing: alignment with the AMDD and full adoption of the CSDT

How EVERBIZ Can Help

EVERBIZ has offices in Shanghai, Hong Kong, Germany, Austria, Singapore, Malaysia, Thailand and Vietnam. For the Thailand market, we offer:

  • Product classification and registration pathway planning
  • Preparation and review of CSDT technical documentation
  • Local authorized representative / registration holder arrangements
  • Submission, responses to deficiency letters and progress tracking
  • Post-market compliance maintenance (changes, renewals, adverse event reporting)

Contact us for a Thailand medical device registration plan and quote, or see our registration services for other countries and regions.

Thailand Medical Device Registration FAQs

Which authority regulates medical devices in Thailand?

The Medical Device Control Division (MDCD) of the Thai Food and Drug Administration (Thai FDA), under the Medical Device Act B.E. 2551 (2008) and its 2019 amendment.

How are medical devices classified in Thailand?

By risk into Class 1 to Class 4, corresponding to different registration types: Listing, Notification and License.

Do foreign manufacturers need a local representative in Thailand?

Yes. Foreign manufacturers must appoint a Thai Local Authorized Representative (LAR) holding an Establishment License, who acts as the legal contact with the Thai FDA.

How long is a Thai medical device registration valid?

Registration certificates are generally valid for 5 years and must be renewed before expiry.

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