Thailand Medical Device Regulatory Framework
Medical device (non-IVD) regulations in Thailand are overseen by the Medical Device Control Division (MDCD) of the Thai Food and Drug Administration (Thai FDA), under the Ministry of Public Health. Any company that manufactures or imports medical devices for sale in Thailand must first obtain the appropriate license to produce or import their devices.
Thailand regulates medical devices according to their level of risk. The regulatory framework is established by the Medical Device Act B.E. 2551 (2008) and updated by the Medical Device Act (No. 2) B.E. 2562 (2019). The current regulations have been in force since 2021.
Thai FDA medical device regulatory pathways
Thailand’s medical device classification system aligns with the ASEAN Medical Device Directive (AMDD). Medical devices and IVDs are classified into four categories of increasing risk: Class 1, Class 2, Class 3, and Class 4. The classification determines the regulatory pathway, documentation requirements, review timelines, and type of license issued. Licenses are valid for five years.
Types of Registration:
Listing (Class 1)
Low‑risk devices, such as bandages and basic instruments, follow the Listing Pathway. Documentation requirements include labeling, IFU, product specifications, device description, materials, Declaration of Conformity, and Letter of Authorization.
Devices on the Thai FDA “Positive List,” identified by GMDN codes, may qualify for automatic approval. On Jan 2025, Thai FDA implemented an auto-approval process for Class 1 professional-use only IVDs and non-IVDs under the positive list application.
Notification (Class 2 and Class 3)
Moderate‑risk devices, including contact lenses and self‑testing IVDs, require a submission in the Common Submission Dossier Template (CSDT) format.
Licensing (Class 4)
High‑risk devices and critical IVDs, such as those for HIV, HBV, or HCV, require a complete CSDT dossier and must undergo a full Thai FDA review.
Devices in Classes 2, 3, and 4 must provide a comprehensive technical file in the CSDT format, which includes risk analysis, validation and verification data, ISO 13485 quality certification, clinical or performance evidence, and letters of authorization. Abridged or reliance pathways may be used to reduce documentation requirements if the device meets Thai FDA eligibility criteria.
Pathways for medical device registration in Thailand
There are three pathways for Class 2, 3, and 4 medical devices and IVDs:
- Full evaluation: This route is the standard registration process with the Thai FDA. It involves a detailed submission of technical documentation in CSDT format and a full review. However, documentation requirements for this route were reduced in 2024. Intended use declaration letters, marketing history declarations, safety declarations, and approval evidence from a reference agency are no longer required.
- Abridged Evaluation Route: The Abridged Evaluation route is an option for devices approved by at least one recognized regulatory agency (US FDA, EU Notified Body, TGA, Japan MHLW, Health Canada, or WHO Prequalification) for a minimum of one year. Certain documents (Summary verification & validation, Risk analysis and waste disposal documentation) may be exempt for this route and avoid specialist review.
- Reliance Route: Medical devices or IVDs with approval from Singapore’s Health Sciences Authority (HSA) are eligible for this route. The submission must be identical to the CSDT file submitted in Singapore, and the Singapore registrant must provide written consent for the HSA to share documentation with the Thai FDA. Applications that meet these requirements bypass the Specialist Review step, which can save 1–3 months of review time, though the exact timeline is not official.
In-country representation requirements for medical devices in Thailand
Foreign manufacturers must appoint a local authorized representative or license holder who maintains a valid Establishment License, which is mandatory for manufacturing or importing medical devices in Thailand. Only Thai nationals or legal entities based in Thailand can apply for this license. Registrations are conducted under the name of the establishment license holder, who also holds the product license.
The license holder assumes full responsibility of your product registration, dossier submission, fee payments, renewals, and ongoing compliance obligations, including post-market vigilance and change notifications, and acts as the official liaison between the foreign manufacturer and the Thai FDA.
Medical device quality management system requirements in Thailand
Manufacturers of moderate‑ to high‑risk medical devices must comply with the updated Good Manufacturing Practice (GMP) standards. Compliance requires holding a GMP certificate, a Thai Conformity Assessment Standard (TCAS 13485) certificate, or an ISO 13485 certificate. Manufacturers of low‑risk devices are exempt from the certification requirement but must still upgrade their facilities and implement quality systems that meet the new GMP standards.
