Authority: Thai Food and Drug Administration under the Medical Device Act B.E. 2551 (2008).
Read the full announcement here: https://medical.fda.moph.go.th/relevant-laws-and-standards/report2026

Purpose
Modernize record-keeping and reporting for manufacture, import, and sale of medical devices.
Improve traceability, auditability, and post-market regulatory oversight.

Scope
Applies to licensed:

• Manufacturers
• Importers
• Notification holders
• Registrants of medical devices in Thailand.

Key Requirements

1. Record Keeping

Entities must maintain records for all devices manufactured, imported, or sold.

Format

• Primarily electronic records.
• Paper allowed if the electronic system is not feasible (Thai or English).
• Must be kept at registered premises and available for inspection.

Retention

• ≥ 5 years from manufacture/import/sale.
• If device has expiry: ≥ 1 year after expiry, but not less than 5 years total.

Minimum data

• Product name
• Manufacture/import date
• License/notification/registration number
• Batch or serial number (if applicable)
• Expiry date (if applicable)
• Quantity manufactured/imported/sold
• Country of manufacture (for imports)
• Responsible operator details

Sales records

• Purchaser/customer information
• Quantity sold

2. Reporting Obligations

Annual reports (submit by 31 May each year):

• Manufacturing report
• Importation report
• Sales report

Special categories

Additional reporting for devices such as:

• Hazardous-substance devices
• Radiation-emitting devices
• Emergency medical devices
• Certain software medical devices

Frequency

• Emergency devices: Quarterly sales report
• Certain software devices: Annual sales report
• Export-only manufacturers: Annual export manufacturing report

3. Submission Method

• Electronic submission is mandatory when the FDA reporting system is available.

4. Business Closure / License Revocation

• All required reports must be submitted within 90 days.

Emergency Medical Device Examples (Annex)

Examples include:

• PCR machines
• Surgical/N95 masks and PPE
• Ventilators and ECMO
• Infusion/syringe pumps
• Pulse oximeters
• Oxygen concentrators and cylinders
• Patient monitors
• Blood pressure monitors
• Gauze, cotton, IV sets, nasal oxygen cannula

(These require quarterly sales reporting.)

Implication for companies:

• Implement/upgrade electronic record systems
• Ensure traceability & retention compliance
• Identify devices requiring special reporting
• Establish processes to meet annual (31 May) and quarterly deadlines.