Thailand is one of the major markets in Southeast Asia. Medical devices are regulated by the Thai Food and Drug Administration (Thai FDA) under the Ministry of Public Health to ensure the safety, efficiency and compliance. Preceding legal entry into the Thai market, registration with the Thai FDA is mandatory. 

The Medical Device Act, B.E. 2551 (2008), and the Medical Device Act (2nd Edition), B.E. 2562 (2019), are the primary local regulations. As an ASEAN member, Thailand also aligns with relevant ASEAN regulations.

Overseas manufacturers must appoint a local licensed representative in Thailand. Registration certificates, valid for five years, are issued to the local representative (License Holder). While Thai regulations presently prohibit changing license holder, the same product can have multiple license holders simultaneously.

The classification of medical devices (including IVD) depends on their type and intended use, spanning from Class 1 (low risk) to Class 4 (high risk). Class 1 products require listing, Class 2 and 3 necessitate notification, and Class 4 products mandate approval (license).

There are three registration pathways in Thailand. The "Concise Pathway" applies to products approved and marketed for over a year in a reference country (EU, Canada, Japan, Australia, the USA, or WHO Prequalification), with no serious adverse events. For devices that have been successfully registered with Singapore's HSA, the "Reliance Program" replicates this. If the product does not meet the above two scenarios, it will need to go through the full evaluation pathway.

Regardless of tthe product‘s risk level, the technical documents shall follow the ASEAN Common Submission Dossier Template (CSDT). Additionally, ISO 13485 quality management system is required for Class 2, 3, and 4 products.

Depending on the classification  and the particular circumstances of the product, Thailand's registration process takes 0-300 days, with costs ranging from tens to $4,000 USD.

Our global team is ready to assist you in navigating the Thai FDA product registration, providing local agency services. For detailed insights, please feel free to reach out to us.