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January 21, 2026
Approximately 5 minutes
Requirements for Medical Device Import Facilities in Thailand
Requirements for Medical Device Import Facilities in Thailand
1. Legal Basis and Purpose
The Notification of the Ministry of Public Health Re: Medical Device Import Facilities (dated 24 July 2009) is issued under the authority of the Medical Devices Act B.E. 2551 (2008). https://en.fda.moph.go.th/media.php?id=482374394027581440&name=20090724%20Notification%20of%20the%20Ministry%20of%20Public%20Health%20Re%20Medical%20Device%20Import%20Facilities.pdf Its primary purpose is to establish mandatory standards for premises used for importing medical devices to ensure that imported products comply with safety, quality, and efficacy requirements throughout the import process.
2. Scope of Application
The Notification applies to all facilities involved in the importation of medical devices into Thailand, including warehouses, storage areas, and related operations of import license holders. It covers both general medical devices and those subject to specific controls (e.g., high-risk classes). https://en.fda.moph.go.th/media.php?id=482374394027581440&name=20090724%20Notification%20of%20the%20Ministry%20of%20Public%20Health%20Re%20Medical%20Device%20Import%20Facilities.pdf
3. Facility and Premises Requirements
Import facilities must meet the following standards:
- Suitable location, size, and construction to prevent contamination, damage, or deterioration.
- Clearly separated areas for receiving, quarantine, inspection, storage, and dispatch.
- Proper flooring, walls, ceilings, lighting, ventilation, and pest control measures.
- Temperature and humidity control appropriate to the types of devices stored (especially for sensitive products such as in vitro diagnostics or sterile items). https://en.fda.moph.go.th/media.php?id=482374394027581440&name=20090724%20Notification%20of%20the%20Ministry%20of%20Public%20Health%20Re%20Medical%20Device%20Import%20Facilities.pdf
4. Equipment and Utilities
Facilities shall be equipped with:
- Appropriate storage racks, shelving, and handling equipment.
- Monitoring devices for temperature, humidity, and other environmental conditions where required.
- Cleaning and sanitation equipment.
- Backup power supply or contingency measures for critical storage conditions. https://en.fda.moph.go.th/media.php?id=482374394027581440&name=20090724%20Notification%20of%20the%20Ministry%20of%20Public%20Health%20Re%20Medical%20Device%20Import%20Facilities.pdf
5. Personnel and Training
- Qualified personnel responsible for import operations, quality control, and record-keeping.
- Staff must receive training on good distribution practices, device handling, and regulatory requirements.
- Designated person(s) accountable for compliance with the Notification. https://en.fda.moph.go.th/media.php?id=482374394027581440&name=20090724%20Notification%20of%20the%20Ministry%20of%20Public%20Health%20Re%20Medical%20Device%20Import%20Facilities.pdf
6. Quality Management and Documentation
Import facilities must implement a quality management system including:
- Written procedures for receipt, inspection, quarantine, release, storage, and distribution.
- Records of incoming shipments, temperature monitoring, deviations, and corrective actions.
- Traceability of devices from import to distribution.
- Procedures for handling complaints, recalls, and adverse event reporting. https://en.fda.moph.go.th/media.php?id=482374394027581440&name=20090724%20Notification%20of%20the%20Ministry%20of%20Public%20Health%20Re%20Medical%20Device%20Import%20Facilities.pdf
7. Inspection and Compliance
The Thai FDA is authorized to inspect import facilities to verify compliance. Non-compliance may result in suspension or revocation of import licenses, product recalls, or other enforcement actions under the Medical Devices Act. https://en.fda.moph.go.th/media.php?id=482374394027581440&name=20090724%20Notification%20of%20the%20Ministry%20of%20Public%20Health%20Re%20Medical%20Device%20Import%20Facilities.pdf
This Notification plays a critical role in ensuring that imported medical devices in Thailand remain safe and effective from the point of entry through distribution to healthcare providers and patients. https://en.fda.moph.go.th/media.php?id=482374394027581440&name=20090724%20Notification%20of%20the%20Ministry%20of%20Public%20Health%20Re%20Medical%20Device%20Import%20Facilities.pdf
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