Thailand’s imports of medical devices are growing noticeably each year, which fits well with the overseas expansion plans of Chinese medical device manufacturers and exporters. To bring medical devices into Thailand, companies need to understand the local regulatory requirements.
The Thai Food and Drug Administration (Thai FDA/TFDA), part of the Ministry of Public Health (MOPH), is responsible for the registration and regulation of medical devices.
Thai FDA website: www.fda.moph.go.th
Thailand classifies medical devices by risk into Class I, Class II, Class III and Class IV, from lowest to highest risk. Class I devices are registered by product listing (self-declaration); Class IV devices require a technical file and rigorous review.
Thailand clearly stipulates that only companies established locally in Thailand may apply to the TFDA for a medical device import licence.
Foreign manufacturers must appoint a legally registered Authorized Representative company in Thailand to handle all communication and applications with the TFDA.
Applying for a medical device licence with the Thai FDA is very similar to the process in China
Thai FDA pre-market and post-market procedures for medical device importers
The Thai FDA regulatory system is closer to ASEAN regional harmonisation standards, making Thailand a good entry point to Southeast Asian markets; China’s regulatory system is stricter and more comprehensive. Both follow international trends in medical device regulation, but differ significantly in the details of implementation:
Recommendations for Chinese companies
At present, medical device certificates issued by China’s NMPA (National Medical Products Administration) do not qualify for the Thai FDA’s abridged registration route. The strategy is to obtain certificates from countries recognised by the Thai FDA – such as CE certification, US FDA clearance or Health Canada licences – and apply through the Thai FDA’s abridged registration route (expedited review programme).
Using the CSDT (Common Submission Dossier Template) allows you to target multiple ASEAN markets at the same time.
The most common approach is to appoint a local Thai company as authorized representative, or to work with an experienced Chinese consultancy familiar with medical device regulation in Southeast Asian countries.
Conclusion
This is a series of educational articles introducing regulations and standards of the FDA, NMPA, GMP, CE MDR/IVDR and MDSAP.
EVERBIZ is happy to share medical device expertise with industry clients, and hopes our extensive practical experience in quality systems and product registration will be helpful.
Let’s contribute together to the development of the medical device industry – if you have any questions or needs, please contact us.
EVERBIZ Certification Services (Shanghai) Co., Ltd. (EVERBIZ) is a professional compliance service platform for testing, certification, consulting and training of medical products, dedicated to helping leading medical R&D companies at home and abroad improve their compliance capabilities and competitiveness. The company has offices and branches in Shanghai (China), Hong Kong, Munich (Germany), Salzburg (Austria) and Thailand, covering nearly 25 industries of compliance products (such as medical devices, new energy, household appliances, lighting, tools, laboratory instruments, machinery, in vitro diagnostics, wireless products and reagents).
Shanghai: Room 909, Building 1, Lane 111 Luxiang Road, Baoshan District, Shanghai, China; Germany: Landsberger Str. 155, 80687 München, Germany
Austria: Innsbrucker Bundesstraße 136/3, 5020 Salzburg, Austria
Hong Kong: Room A1, 11/F Winner Building, 36 Man Yue Street, Hung Hom, Kowloon, Hong Kong
Thailand: No. 850 Soi Lat Krabang 30/5, Lat Krabang Subdistrict, Bangkok 10520
