The secretary of the Food and Drug Administration has issued a new Announcement to regulate the management, declaration, and reporting of remaining quantities and storage facilities of medical devices following:
- Business termination
- Non-renewal or refusal of renewal of Business establishment license, medical device licenses, notified certificates and listed certificates
This announcement repeals and replaces the previous FDA Announcement B.E. 2564 (2021).
Purpose of the Announcement
To regulate the management, declaration, and reporting of remaining quantities and storage facilities of medical devices following business termination, non-renewal, or refusal of renewal of Business establishment license, medical device licenses, notified certificates and listed certificates.
Read the full announcement here: กองควบคุมเครื่องมือแพทย์
Scope of Application
This Announcement applies to registrants of business establishments, medical device licenses, notified certificates, and listed certificates of medical devices who:
- Terminate business operations
- Do not renew their licenses
- Are refused renewal authorization
Key Provisions
Clause 1: Effective Period
This announcement shall become effective 180 days after publication in the Royal Gazette.
Clause 2: Repeal of Previous Regulation
The Food and Drug Administration Announcement: Criteria, Methods, and Conditions for Business termination, Remaining Quantity, and Storage Facility of Medical Devices after Business Cessation, Non renewal or Revocation of Business Establishment License, Medical Device License, Notified Certificate, or Listed Certificates of Medical Device under B.E. 2564 (2021) is officially revoked.
Clause 3: Business Termination
Registrants of business establishments, medical device licenses, notified certificates, or listed certificates, who cease business operations must submit a business termination notification letter declaring the remaining quantity of medical devices and storage facilities using Lor.Por 1 form within 30 days from the date of business termination.
Clause 4: Non-Renewal or Refusal of License Renewal
Registrants of establishments, medical device licenses, notified certificates, who do not wish to renew their licenses or are not authorized by Thai FDA to renew the license must declare the remaining quantity of the medical devices and the storage facilities according to the Lor.Por 2 form. The Notification and report shall be submitted within 30 days from the expiry date of the licenses, or from the date that the Thai FDA does not give renewal authorization.
Clause 5: Sale of Remaining Medical Devices
Sellers of medical devices under Section 24 of Medical Devices Act., whose business has been terminated or licenses has expired or renewal is denied by FDA who still hold remaining medical devices, shall report the remaining quantity of medical devices and storage facilities according to the Lor.Por 3 form if the remaining device sold is recognized by the authority in Section 38, paragraph 1. The report shall be submitted within 15 days after the date stated in section 38, paragraph 1.
Clause 6: Submission Method
The notification and reports must be submitted electronically. If electronic submission is not possible, submissions may be made at the Food and Drug Administration, Ministry of Public Health, or other locations specified in the Royal Gazette.
Clause 7: Transitional Provision
The notifications of business termination submitted prior to the effective date of this announcement shall be deemed compliant with the new requirements.
Implications for Clients
The registrants of the business establishments, medical device licenses, notified certificates, and listed certificates of medical devices who intend to terminate business operations or not renew their license should:
- Prepare timely notification letters and reports
- Accurately declare remaining quantities and storage facilities using the correct Lor Por forms
- Ensure submissions are made within the prescribed timelines
- Transition to electronic submission when available
Failure to comply may result in regulatory non-compliance under Thai medical device regulations.
Effective Date
This announcement shall come into force 180 days after its publication in the Royal Gazette.
For Inquiries
For inquiries or support regarding medical device regulatory requirements in Thailand, please contact sales@andamanmed.com.
