Thailand: Announcement on the Reporting of Production, Import, or Sale of Medical Devices

On September 5, 2025, the Ministry of Public Health of Thailand released a draft announcement regarding the Criteria, Methods, and Conditions for Recording and Reporting the Production, Import, or Sale of Medical Devices. This draft is issued under the authority of the Medical Device Act B.E. 2551, as amended, and is intended to replace the existing 2021 regulation.

Scope

This draft announcement establishes updated requirements for record-keeping and reporting by medical device manufacturers, importers, and sellers in Thailand, with the aim of strengthening oversight, compliance, and transparency.

Key Points

1. Record-Keeping Requirements
   • Manufacturers and importers must maintain records in Thai or English, either in document or electronic form, at the registered production or import location.
   • Records must be kept for at least 5 years from the date of production, import, or sale (or at least 1 year after expiry, but not less than 5 years in total).
   • Information required includes:
     • Device name, production/import date, license number, batch/lot or serial number, expiry date (if applicable), and quantity.
     • For sales, additional information on the buyer and transaction details must be recorded.
2. Reporting Obligations
   • Annual Reports:
     • Form Ror.Por.Por 1 – Production of medical devices.
     • Form Ror.Nor.Por 1 – Import of medical devices.
     • Form Ror.Kor.Por 1 – Sale of medical devices (for designated categories such as software medical devices).
   • Quarterly Reports: Required for medical devices containing mercury, radioactive substances, or essential emergency devices listed in the appendix (e.g., ventilators, PPE, infusion pumps).
   • Export Certificates: Manufacturers with export certificates must submit Form Ror.Por.Por 2 annually.
3. Submission Deadlines
   • Annual reports must be submitted by May 31 of the following year.
   • Quarterly reports follow these deadlines:
     • January–March sales → submit in May
     • April–June sales → submit in August
     • July–September sales → submit in November
     • October–December sales → submit in February
4. Cessation of Business
   • In cases of business closure, license non-renewal, or revocation, final reports must be submitted within 90 days.
5. Electronic Submissions
   • Reports and communications will be carried out via the official electronic system. If unavailable, submission can be made at the Thai FDA or as designated by the Secretary-General.

Attachment

See attached draft announcement from the Ministry of Public Health of Thailand (available in Thai only).

Effective Date

This announcement will come into force 30 days after publication in the Government Gazette.

Implications to Clients

This regulation applies to all license holders, notification holders, listing holders, and designated licensed sellers of medical devices. Stakeholders are required to establish and maintain robust internal systems to ensure proper record-keeping and the timely submission of both quarterly and annual reports, depending on the type of medical device. Proactive compliance will safeguard market access and prevent regulatory penalties.

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