TFDA Medical Device GDP: Good Distribution Practices for Importers of Medical Devices in Thailand – Compliance with New Regulations
The regulatory landscape for medical device importers in Thailand has undergone significant changes with the issuance of new TFDA Medical Device GDP regulations under the Royal Gazette, Volume 141, Special Section 4, dated 5 January 2024. These regulations mandate adherence to Good Distribution Practices (GDP) to ensure the quality, safety, and performance of medical devices.
This new regulation, implemented over a three-year period, will sweep away the horde of freelancers working from their own bedrooms and importers of medical devices who cannot meet the minimum hygiene, safety, and service standards that will now be imposed by the new rules.
Chapter 1: Organization Management System and Determination of Duties and Responsibilities
1.1 Organization and Responsibilities according new TFDA Medical Device GDP
- Establish and Maintain a Management System: Importers must develop a management system aligned with the principles and methods for importing or selling medical devices.
- Define Authority, Duties, and Responsibilities: Create an organizational structure diagram outlining authority, duties, and responsibilities to ensure quality, safety, and performance.
- Personnel Responsibilities: Ensure that personnel responsible for managing, performing, and verifying work maintain the required quality, safety, and performance standards of medical equipment.
1.2 Document Management
- Operational Documents: Prepare and maintain documents detailing the organization’s history, scope of sales, necessary procedures, and compliance records.
- Device-Specific Files: Maintain files for each type of medical device, including specifications, import processes, installation features, and service requirements.
1.3 Document and Record Control
- Organize and Maintain Records: Ensure documents and records of the management system are easily identified and accessible, and keep records for the required periods considering shelf life and legal requirements.
1.4 Management Review
- Annual Reviews: Conduct annual reviews to ensure the system is appropriate, adequate, and effective. Reviews should include past results, internal audits, complaints, operational reports, and feedback from customers and regulatory agencies.
Chapter 2: TFDA Medical Device GDP Resource Management
2.1 Personnel
- Competency and Training: Identify necessary competencies for personnel and provide training and support. Keep records of education, training, skills, and experiences.
2.2 Basic Utilities
- Infrastructure Maintenance: Provide and maintain buildings, tools, equipment, and support services to ensure compliance. Document maintenance activities and keep records.
2.3 Cleanliness and Pest Control
- Cleaning and Pest Control: Document cleaning requirements and pest prevention programs, maintaining relevant records.
Chapter 3: Supply Chain and Equipment Specifications
3.1 Obtaining Permission
- Regulatory Permissions: Obtain written permission from relevant regulatory agencies and maintain written agreements.
3.2 Communication Channels
- Establish Communication Channels: Maintain effective communication channels and feedback processes with relevant agencies.
3.3 Inventory Management
- Inventory Systems: Implement systems for the inspection, storage, turnover, and delivery of medical equipment.
3.4 Control of Non-Conforming Medical Devices
- Handling Non-Conforming Devices: Document procedures for managing and separating non-conforming or returned medical devices.
3.5 Destruction of Medical Devices
- Lawful Destruction: Document procedures for the lawful destruction of medical devices and maintain records.
3.6 Distribution Records and Traceability
- Traceability: Document all activities related to the distribution of medical equipment, ensuring traceability throughout the supply chain.
3.7 Calibration
- Equipment Calibration: Ensure equipment used for maintaining and distributing medical devices is calibrated and verified.
3.8 Special Characteristics for Powerful Medical Devices
- Testing and Maintenance: Document procedures for testing, calibration, maintenance, and verification of powerful medical devices.
3.9 Installation and Service
- Installation Procedures: Document installation and service procedures, ensuring compliance with specific requirements.
3.10 Outsourcing
- Outsourcing Control: Control the outsourcing process and document written agreements with outsourced agencies.
3.11 Counterfeiting and Adulteration
- Label and Notify: Separate and clearly label counterfeit, adulterated, or modified medical devices, notifying relevant authorities immediately.
Chapter 4: Inspection and Surveillance
4.1 Complaints
- Complaint Management: Document procedures for managing complaints, reviewing related information, and reporting to relevant agencies.
Timeline for Compliance with TFDA Medical Device GDP
Immediate (0-3 Months)
- Establish Management System: Develop and implement a comprehensive management system.
- Document Preparation: Begin preparing and organizing necessary operational documents and device-specific files.
- Initial Training: Start training programs for personnel to ensure competency and compliance with new regulations.
Short Term (3-6 Months)
- Document Control Systems: Implement systems for organizing and maintaining documents and records.
- Infrastructure Improvements: Ensure basic utilities and pest control measures are documented and maintained.
- Inventory Systems: Set up inventory management systems and procedures for handling non-conforming devices.
Medium Term (6-12 Months)
- Management Review: Conduct the first annual management review.
- Calibration and Maintenance: Ensure all equipment is calibrated and maintenance activities are documented.
- Communication Channels: Establish and formalize communication channels with regulatory agencies.
Long Term (12-24 Months)
- Ongoing Training: Continue training programs and keep records of personnel competencies.
- Continuous Improvement: Regularly review and update systems for document control, inventory management, and complaint handling.
- Traceability and Compliance: Maintain distribution records and ensure full traceability and compliance with all regulatory requirements.
By following this structured timeline and adhering to the specified actions, importers of medical devices in Thailand can ensure compliance with the new regulations. This not only guarantees the quality and safety of medical devices but also enhances the trust and reliability of the importers in the Thai healthcare market.
Below the document source of this article on TFDA Medical Device GDP.
Announcement of the Ministry of Public Health Regarding the Quality System for the Import or Sale of Medical Devices
Page 263 Volume 141, Special Section 4, Royal Gazette 5 January 2024
To ensure the quality, safety, and effectiveness of imported or sold medical equipment and to protect consumers, it is appropriate to establish a quality system for these activities.
By virtue of Section 5, paragraph one, and Section 2 (5) of the Medical Devices Act B.E. 2008, the Minister of Public Health, with the advice of the medical equipment committee, issues the following announcement:
Clause 1: This announcement shall come into force one year after its publication in the Royal Gazette.
Clause 2: The quality system for importing or selling medical devices must adhere to the criteria and good practices outlined in this announcement.
Clause 3: The quality system for importing or selling medical devices applicable to persons under section 41 (1) shall be as specified below:
- From the effective date of this announcement, comply with Section 2 and Section 3 of the principles and good procedures for importing or selling medical equipment.
- From 1 January 2027, comply with Section 2, Section 3, and Section 4 of the rules and procedures for importing or selling medical devices.
- From 1 January 2029, comply with Section 1, Section 2, Section 3, and Section 4 of the criteria and good methods for importing or selling medical equipment.
Clause 4: For registrants, importing establishments, or licensees selling medical devices before the effective date of this announcement, the quality system shall be as follows:
- After one year from the effective date of this announcement, comply with Section 2 and Section 2 of the Good Criteria and Procedures for importing or selling medical devices.
- From 1 January 2030, comply with Section 2, Section 3, and Section 4 of the rules and procedures for importing or selling medical devices.
- From 1 January 2034, comply with Section 1, Section 2, Section 3, and Section 4 of the criteria and good methods for importing or selling medical equipment.
Clause 5: Criteria, methods, and conditions for inspecting and evaluating quality systems according to Clause 2 shall be in accordance with the manual announced by the Food and Drug Administration.
Clause 6: The Secretary-General of the Food and Drug Administration shall oversee this announcement. In case of issues, the Secretary-General shall have the authority to make the final decision.
Good Criteria and Methods for Importing or Selling Medical Devices
Chapter 1: Organization Management System and Determination of Duties and Responsibilities
1.1 Organization and Responsibilities:
- Establish and maintain a management system consistent with the principles and methods for importing or selling medical devices.
- Define authority, duties, and responsibilities through an organizational structure diagram.
- Ensure personnel responsible for managing, performing, and verifying work maintain quality, safety, and performance of medical equipment.
1.2 Document Management:
- Prepare and maintain operational documents including organization history, scope of sales, necessary procedures, and compliance records.
- Keep a file for each type of medical device detailing specifications, import processes, installation features, and service requirements.
1.3 Document and Record Control:
- Organize and maintain necessary documents and records of the management system, ensuring they are easily identified and accessible.
- Keep records for the specified periods, taking into account the shelf life and legal requirements.
1.4 Management Review:
- Conduct annual management reviews to ensure system development is appropriate, adequate, and effective.
- Include reviews of past results, internal audits, complaints, operational reports, and feedback from customers and regulatory agencies.
Chapter 2: Resource Management
2.1 Personnel:
- Determine necessary competencies for personnel and provide adequate training and support.
- Keep records of education, training, skills, and experiences.
2.2 Basic Utilities:
- Provide and maintain necessary buildings, tools, equipment, and support services to ensure compliance.
- Document maintenance activities and keep records.
2.3 Cleanliness and Pest Control:
- Document cleaning requirements and pest prevention programs, keeping relevant records.
Chapter 3: Supply Chain and Equipment Specifications
3.1 Obtaining Permission:
- Receive written permission from relevant regulatory agencies and maintain written agreements.
3.2 Communication Channels:
- Establish and maintain communication channels and feedback processes with relevant agencies.
3.3 Inventory Management:
- Implement systems for inspection, storage, inventory turnover, and delivery of medical equipment.
3.4 Control of Non-Conforming Medical Devices:
- Document procedures for handling and separating non-conforming or returned medical devices.
3.5 Destruction of Medical Devices:
- Document procedures for the lawful destruction of medical devices and keep records.
3.6 Distribution Records and Traceability:
- Document all activities related to the distribution of medical equipment, ensuring traceability throughout the supply chain.
3.7 Calibration:
- Ensure equipment used for maintaining and distributing medical devices is calibrated and verified.
3.8 Special Characteristics for Powerful Medical Devices:
- Document procedures for testing, calibration, maintenance, and verification of powerful medical devices.
3.9 Installation and Service:
- Document installation and service procedures, ensuring compliance with specific requirements.
3.10 Outsourcing:
- Ensure control over the outsourcing process and document written agreements with outsourced agencies.
3.11 Counterfeiting and Adulteration:
- Separate and clearly label counterfeit, adulterated, or modified medical devices, notifying the relevant authorities immediately.
Chapter 4: Inspection and Surveillance
4.1 Complaints:
- Document procedures for managing complaints, reviewing related information, and reporting to relevant agencies.
More on Medical Devices:
Medical Devices Regulatory: List of Accepted Foreign Agencies
Thai FDA Medical Device: Understanding the Impact of Partial 2 Submission Termination
Essential Licenses and Quality Certifications for Establishing a Medical Device Factory
