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“The advertising approval exemption will ease the regulatory burden for medical device manufacturers looking to sell in Thailand.”

Binh Thai, Asia Actual Thailand

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New Medical Device Advertising Exemption in Thailand

Published on: November 30, 2020

Published by the Thai Ministry of Public Health on November 2, 2020, Gazette Volume 137, Section 2074, announces that medical devices sold to healthcare professionals are now exempt from some previous advertising requirements in Thailand. Under the new notification, medical device manufacturers do not need advertising approval anymore if they are selling products to healthcare professionals. These new regulations put Thailand in better alignment with other countries in the region and around the world, where pre-market advertising approval is not required. The shift in focus away from advertising regulation will be good for the medical device industry, removing a significant regulatory burden for manufacturers. 

This change is likely due to the upcoming implementation of new regulations expected in the near future and to better align with international marketing practices. It is important to note that this only applies to healthcare professionals and manufacturers selling directly to consumers will still need advertising approval before printing  in the Thai market. 

How to Maintain Compliance

Advertisers who are exempt from requesting permission to advertise will still need to submit a notification to the FDA as outlined in page 3 of the Gazette announcement. The submitted form will need to include information on the manufacturer, product, regulatory status, place and timing of the advertising, methods for limiting advertising to healthcare professionals only,  and a copy of the planned advertisement.

Lastly, the form also requires the manufacturer certify that the advertising restricted to healthcare professionals only and is not in violation of Section 59 of the Medical Device Act B.E. 2551 (2008) which states:

A medical device advertisement must:

  1. not be a false or exaggerated representation of the benefits, quality, quantity, standard, constituent or origin of the medical device;
  2. not represent any person’s endorsement or commendation of the medical device’s benefits;
  3. not offer a prize conditional upon the taking of chance by any means;
  4. not represent benefits in regard to the prevention, treatment, relief or cure of a disease or symptom of a disease of which advertisement is prohibited under a Notification published by the Minister;
  5. not contain a misleading statement on an essential substance in relation to the medical device.

Come Grow with Us

Contact Asia Actual if you’d like to learn how this regulation might affect your sales options in Thailand.

Asia Actual is a regulatory consulting company specializing in helping manufacturers grow their sales through independent license holding, direct fulfillment, and a variety of sales channel support services.

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