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
- 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
- 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
- Submission Method
- Electronic submission is mandatory when the FDA reporting system is available.
- 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.
