Regulatory Affairs Update: Thailand

Thailand: Draft Announcement of Guidelines for Submitting Applications for Medical Device Advertisement that Requires Academic Document Evaluation

On May 20, 2024, the Ministry of Public Health of Thailand issued a notification regarding medical devices prohibited from direct sales or direct marketing under the law governing Direct Sales and Direct Marketing. By Section 5, Paragraph One, and Section 6 (12) of the Medical Device Act B.E. 2551 (2008), the Minister of Public Health, upon the advice of the Medical Device Committee, issues the following announcement:

  • “Medical devices for home use” means medical devices intended for use by the public, who can use or interpret the results by themselves after studying the instructions on the label or instructions for use without the need for guidance from medical practitioners and public health professionals.
  • “Medical devices not for home use” means medical devices not intended for use by the general public and require guidance for use or use by medical practitioners and public health professionals.

Therefore, under the Law Governing Direct Sales and Direct Marketing, medical devices not for home use are prohibited from selling through direct sales or direct marketing businesses.

Further information can be accessed here กองควบคุมเครื่องมือแพทย์ (moph.go.th) (in Thai). This announcement shall come into force 180 days after the date of its publication in the Royal Gazette [Published in the Royal Gazette on June 21, 2024, Volume 141, Special Part 171 D, Page 5].

If you have any queries about this draft guidance, please contact us at sales@andamanmed.com or click the button below.

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