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In brief

Pursuant to our previous articles about medical devices and their development in Thailand following the Medical Device Act B.E. 2551 and its amendments, which were adjusted according to the ASEAN Medical Device Directive (AMDD), there have been more updates on the medical device regulations under the Thai Food and Drug Administration (FDA).


Key Takeaways

The groups of medical devices and medical device classifications from risk assessments are now clear. Some medical devices were reclassified (e.g. surgical gloves from being Class III to Class II and active machinery and equipment from being Class I to Class II) and the quality standards for certain types of medical devices have been established (e.g. medical masks and surgical gloves) to ensure that they are suitable for use in accordance with the manufacturer’s intended uses. In addition, registration and notification are now carried out electronically, and a pre-submission process is added as the first process. This process can be challenging as it requires good knowledge of medical device classification and grouping as this will help contribute to a successful registration or notification.

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Author

Peerapan Tungsuwan is a corporate and M&A partner in Bangkok office with specialties in highly regulated industries, including the healthcare industry. She is currently Chair of the AEC Healthcare Harmonization Sub-committee of Baker McKenzie's Asia Pacific Healthcare Industry Group, of which she was head from 2007-2013. Within the Bangkok office, she heads the Healthcare Industry and Natural Resources Groups and co-leads the Mergers & Acquisitions practice group and Japan Advisory Group.

Author

Panyavith assists major local and multinational clients in a range of heavily regulated industries, such as healthcare & life sciences and petrochemical, on large complex mergers and acquisitions, private equity transactions, joint ventures, corporate restructurings, and post-acquisition integration projects. 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.

Author

Praween Chantanakomes is an associate at Baker & McKenzie’s Bangkok office. He was admitted in 2008. He is currently active in the Corporate & Commercial, Mergers & Acquisitions, Environment, Natural Resources, and Pharmaceuticals practice groups.

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