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Product Regulation & Liability

Thailand: Thai FDA issues regulations on quality systems for medical devices

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In brief

The Thai Food and Drug Administration (FDA) has recently issued two notifications, namely the Notification of the Ministry of Public Health Re: Good Manufacturing Practice, B.E. 2566 (2023) (“GMP Notification“), and the Notification of the Ministry of Public Health Re: Good Importing and Sales Practice, B.E. 2566 (2023) (“GISP Notification“). These notifications aim to regulate the quality systems of medical device manufacturing facilities, as well as importers and sellers of medical devices.

In more detail

From July 2024, new manufacturers of moderate-risk to high-risk medical devices must comply with the standards specified in the GMP Notification (which includes the obligation to obtain the GMP Certificate, the Thai Conformity Assessment Standard – TCAS 13485 Certificate, or the ISO 13485 Certificate). Manufacturers of low-risk medical devices and medical devices for animals will also be required to improve their manufacturing facilities to comply with the quality systems required under the GMP Notification (though they are not required to obtain the GMP Certificate, the TCAS 13485 Certificate, or the ISO 13485 Certificate).

Under the GMP Notification, manufacturers of moderate-risk to high-risk medical devices who obtained the GMP Certificates under the previous standards before July 2024 may continue their operations without the need to obtain the new required certificates (as outlined above), though they will still be required to comply with the new standards as provided under the GMP Notification. However, the new required certificates must be obtained within the given grace periods.

Importers and sellers of medical devices must start preparing their quality systems for the import and sale of medical devices in accordance with the GISP Notification, which will come into effect on 5 January 2025. By January 2029, all importers and sellers of medical devices must fully comply with the GISP Notification.

For more information or assistance, please contact our Healthcare & Life Sciences and Regulatory Affairs Services team.

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Peerapan is a Corporate and M&A partner and heads the Sustainability Group and Healthcare & Life Sciences Industry Group in Bangkok. She also co-heads the Investigations, Compliance & Ethics Practice Group in Bangkok and is currently a member of the Firm's Global Executive Committee. Peerapan has nearly 40 years of experience advising on transactional and regulatory matters in highly regulated industries. Peerapan is exceptionally fluent in regulatory matters relating to healthcare, consumer protection and product liability.
Peerapan also has extensive experience advising on compliance issues, risks facing companies across various industry sectors, and regularly assists clients in practically managing and mitigating those risks. She has been consistently recognized as 'Leading Individual’ in Corporate M&A by the Asia Pacific Legal 500 for eight consecutive years (2013-2020) and has been inducted into the Asia Pacific Legal 500 Hall of Fame in Corporate M&A in 2020-2023. More recently she has been shortlisted for Corporate and M&A Lawyer of the Year by the Legal 500 Southeast Asia Awards. Peerapan was also awarded ‘Client Choice winner’ for Healthcare & Life Sciences 2019 by Lexology.
In October 2022, Peerapan was elected to join the Global Executive Committee and serve as chair of the Asia Pacific region. In this role, Peerapan works alongside the Firm's leadership to drive forward the Firm’s business strategy and prioritized actions.

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Panyavith assists major local and multinational clients in a range of heavily regulated industries, such as healthcare & life sciences, chemical and biotech, on large complex mergers and acquisitions, private equity transactions, joint ventures, corporate restructurings, post-acquisition integration projects, commercial agreements and regulatory issues. With his technical and commercial astute, Panyavith has often been involved in a number of pioneering projects, helping clients navigate the challenges of uncharted waters and emerging opportunities with innovative solutions. He is recently recognized as "Up and Coming for Corporate and M&A" in Thailand by Chambers Asia-Pacific 2023.

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Praween Chantanakomes is the Head of Regulatory Affairs Department in Baker McKenzie, Bangkok office.

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Prim Uditananda is a Regulatory Affairs Manager in Baker McKenzie, Bangkok office.

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Saowanee Kasinpila is a Regulatory Affairs Officer in Baker McKenzie Bangkok office.

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