The Thai Food and Drug Administration (Thai FDA) has amended its announcement regarding the importation of medical devices in quantities necessary for personal use, under Section 27(5) of the Medical Device Act B.E. 2551 (2008). The new draft, B.E. 2567 (2024), specifies conditions under which certain medical devices are exempt from requiring a medical certification from a licensed medical professional.
This amendment is issued under the authority of Section 1(10), second paragraph of the Ministry of Public Health Notification on the Criteria, Methods, and Conditions for the Production or Importation of Exempted Medical Devices, dated June 2, B.E. 2563 (2020).
This amendment is issued under the authority of Section 1(10), second paragraph of the Ministry of Public Health Notification on the Criteria, Methods, and Conditions for the Production or Importation of Exempted Medical Devices, dated June 2, B.E. 2563 (2020).
Key Sections of the Draft Announcement
Section 1: Effective Date
This announcement shall take effect upon its publication in the Government Gazette.
Section 2: Revocation of Previous Announcement
The previous Food and Drug Administration Announcement on the Importation of Medical Devices for Personal Use, which provided similar exemptions, B.E. 2567 (2024), is hereby revoked.
Section 3: Exemptions from Medical Certification Requirements
Medical devices that meet the following criteria are exempt from requiring medical certification from a licensed medical professional:
- Personal Belongings– Medical devices imported as personal belongings for personal use, as listed in Attached List 1.
- Personal Orders– Medical devices ordered by individuals for personal use, as listed in Attached List 2.
- Devices Currently in Use– Medical devices brought into the country by individuals who are already using them at the time of entry.
- Accessories for Medical Devices– Accessories accompanying medical devices in category (3), provided they are for use not exceeding 30 days.
- Devices Used with Legally Imported Drugs– Medical devices brought in for use with legally imported drugs, where the drug label specifies:
- The name of the user, who must be the same person bringing the medical device.
- The name of the drug, in compliance with relevant drug laws.
Section 4: Final Decision Authority
In cases of uncertainty or disputes regarding permissions under this announcement, the Secretary-General of the Food and Drug Administration shall have the authority to make the final decision.
Further Information
For more details, visit the Thai FDA Official Website (in Thai):
กองควบคุมเครื่องมือแพทย์ (moph.go.th)
For inquiries or assistance, contact us at sales@andamanmed.com or click the button below to contact us.
กองควบคุมเครื่องมือแพทย์ (moph.go.th)
For inquiries or assistance, contact us at sales@andamanmed.com or click the button below to contact us.