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In brief

The Food and Drug Administration (FDA) has recently updated a number of regulations related to certain medical devices to ensure that they are carefully monitored and controlled, have prescribed quality standards, and are safe for consumers. The updated regulations relate to alcohol detecting devices, positive airway pressure (PAP) devices and dentistry devices.


In more detail

The FDA has recently updated a number of regulations related to alcohol detecting devices, PAP devices and dentistry devices. Some of the key issues that should be noted under the updated regulations, which have been issued under several Notifications of the Ministry of Public Health, are:

  • Devices used to detect alcohol levels through body fluids and are used for medical purposes will continue to be classified as medical devices. However, breathalyzers used solely to detect alcohol levels without a medical purpose will no longer be considered medical devices.
  • Sellers of PAP devices will now be required to obtain a medical device sales license from the FDA before they may sell PAP devices. Generally, sellers of PAP devices will only be able to sell PAP devices to consumers who have a prescription from medical professionals (i.e., doctors), though there are certain exceptions.
  • Sellers of dentistry devices manufactured for dentistry or for use by dentistry professionals (i.e., dentists) (or under the supervision of dentists), as listed under the relevant notification (e.g., dental implants, orthodontic wires, clear dental aligners, dental filling materials, artificial teeth and fluoride varnish), will now be required to obtain a medical device sales license from the FDA before they may sell such dentistry devices. Sellers of these dentistry devices can also only sell them to medical facilities which are used for the conduct of the dentistry profession, dentists, or other persons who hold the medical device sales license. However, artificial teeth can only be sold to licensed manufacturers of dentistry devices.

The sellers of PAP devices and dentistry devices (as the holder of the medical device sales license) will be subject to additional obligations under the Medical Device Act and the relevant notifications.

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

Author

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.

Author

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.

Author

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

Author

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

Author

Monsicha Boonsiri is a Regulatory Affairs Officer in Baker McKenzie Bangkok office.