The Ministry of Public Health has issued a new Announcement to update and modernize the requirements for record keeping and regulatory reporting related to the manufacture, importation, and sale of medical devices in Thailand under the Medical Device Act B.E. 2551 (2008), as amended. The objective of this Announcement is to strengthen regulatory oversight, ensure that records are complete, accurate, traceable, and auditable, and support effective post-market control of medical devices.
Purpose of the Announcement
To update and modernize the requirements for record keeping and regulatory reporting related to the manufacture, importation, and sale of medical devices in Thailand under the Medical Device Act B.E. 2551 (2008), as amended.
To strengthen regulatory oversight, ensure that records are complete, accurate, traceable, and auditable, and support effective post-market control of medical devices.
Read the full announcement here: https://medical.fda.moph.go.th/relevant-laws-and-standards/report2026
Scope of Application
This Announcement applies to licensed manufacturers, importers, notification holders and registrants of medical devices in Thailand.
Key Regulatory Requirements
1. Record-Keeping Obligations
Licensed manufacturers, importers, notification holders and registrants must maintain records for all medical devices they manufacture, import, or sell.
2. Format
Records must be maintained primarily in electronic format.
If electronic systems are not feasible, records may be kept in documentary form in Thai or English.
Documentary records must be stored at the registered business premises and be available for inspection by authorities.
3. Retention Period
At least five (5) years from the date of manufacture, importation, or sale.
For devices with expiry dates, records must be kept for at least one (1) year after expiry, but not less than five (5) years in total.
4. Minimum Record Details
Records must include:
- Product name
- Date of manufacture or importation
- License number, notification numbers, or registration number
- Batch or serial numbers (if applicable)
- Expiry date (if applicable)
- Quantity manufactured, imported or sold
- Country of manufacture (for imported devices)
- Name and details of the responsible operator
5. Sales Records
- Purchaser or customer information
- Quantity sold
Reporting Requirements
1. Mandatory Annual Reports
- Annual manufacturing report
- Annual importation report
- Annual sales report
2. Special Reporting Categories
Additional reporting obligations apply to specific device categories listed in the Annexes including:
- Medical devices containing hazardous substances
- Radiation-emitting medical devices
- Emergency medical devices
- Software medical devices used by healthcare professionals
3. Reporting Frequency
- Emergency medical devices: Quarterly sales report
- Certain software medical devices: Annual sales report
- Export-only manufacturers: Annual export manufacturing report
Submission Timelines and Method
Annual reports
Must be submitted by 31 May of the following year.
Quarterly reports
Must follow the timelines prescribed in the Announcement.
Cessation of business or license revocation
All required reports must be submitted within 90 days.
Submission Method
Electronic submission is mandatory where an electronic reporting system is available.
Implications for Clients
Manufacturers, importers, and distributors of medical devices in Thailand should:
- Review and, if necessary, upgrade their internal electronic record-keeping systems
- Ensure data completeness, traceability and audit readiness
- Confirm that record retention periods are properly implemented
- Identify whether their products fall under special reporting categories
- Prepare internal workflows to ensure timely submission of annual, quarterly, or export reports
Failure to comply with the revised requirements may result in regulatory non-compliance and enforcement actions under Thai medical device regulation.
Effective Date
This Ministry of Public Health Announcement shall come into force on 1 March 2026.
Annexes
Emergency device lists RE; Criteria, Procedures, and Conditions for Record Keeping and Reporting of the Manufacture, Importation, or Sale of Medical Devices (B.E. 2568)
- Real time PCR machine
- Surgical mask/ Medical mask
- Disposable medical mask (N95 or upper)
- Personal Protective Equipment: PPE
- Surgical gown
- Isolation Gown
- Thermometer and its devices
- Medical Ventilator
- Hospital bed/ patient bed
- Infusion Pump
- Pressure Control Ventilation: PCV (for adult)
- Pressure Control Ventilation: PCV (for child)
- Volume Controlled Ventilator – Volume control (for adult)
- Volume Controlled Ventilator – Volume control (for child)
- Pressure Control Ventilation: PCV and VC
- Pressure Control Ventilation: PCV and VC and Pressure controlled
- Volume Controlled Ventilator High-Frequency Ventilation – HFV for child
- Pressure Control Ventilation: PCV and VC with air supply devices system
- Artificial Manual Breathing Unit (for adult)
- Artificial Manual Breathing Unit (for child)
- Artificial Manual Breathing Unit (for infant)
- Powered Air-Purifying Respirators: PAPR
- Extracorporeal membrane oxygenation: ECMO
- Automated Nucleic Acid Extractor
- Syringe pump
- Nebulizer
- Hand -held pulse oxygenometer
- Fingertip Pulse Oximeter
- Needle
- Negative pressure isolation chamber
- Suction elmaslar
- Syringe without needle
- Syringe with needle
- High Flow Nasal Cannula: HFNC
- UV-C Sterilizer
- Oxygen concentrator (Home use)
- Oxygen concentrator (Point of care)
- Oxygen tank, Medical Oxygen cylinder
- Pressure regulator (Non-electrical)
- Pressure regulator (Electrical)
- Flow meter (Non-electrical)
- Flow meter (electrical)
- Patient Monitor
- Central Monitoring System
- Blood Pressure Monitor
- Sterilize cotton
- Gauze
- Intravenous Set
- Nasal Oxygen Cannula
For Inquiries
For inquiries or support regarding medical device regulatory requirements in Thailand, please contact sales@andamanmed.com.
