Essential Licenses and Quality Certifications for Establishing a Medical Device Factory

Effective from July 3rd, 2024, to open a medical device factory according to the text provided, the necessary licenses and standard quality certificates are as follows:

Licenses and Quality Certifications for Establishing a Medical Device Factory

1. License to Operate:

1. • A general license to operate a manufacturing establishment for medical devices.
   • This includes registration of the manufacturing establishment with the relevant health authority.

2. Quality Management System Certification:

1. • ISO 13485:2016: Certification for the Quality Management System specific to medical devices, ensuring compliance with regulatory purposes.
   • National Inspection and Certification Standards: Compliance with standard No. M.T.C. 13485-2019 or future updates as promulgated.

Quality System Requirements

The quality system for medical device production must comply with one or more of the following standards:

1. Good Manufacturing Practices (GMP):

1. • Adherence to criteria and methods for producing medical devices as detailed in the appendix of the Ministry of Public Health’s announcement.

2. International Standards:

1. • Compliance with the International Organization for Standardization (ISO) standards, specifically ISO 13485:2016 for medical devices.

3. National Standards:

1. • Compliance with the national inspection and certification standards for medical device quality management systems (M.T.C. 13485-2019).

Additional Requirements

• Risk Classification Compliance:

• • Depending on the type of medical devices being produced (Type 1, 2, 3, or 4), the factory must adhere to specific control and supervision standards.
  • For Type 1 devices: Compliance with item 3 (1) or item 3 (2) or item 3 (4) or item 3 (5).
  • For Types 2, 3, and 4 devices: Compliance with item 3 (1), item 3 (2), or item 3 (3).

• Implementation of a Quality Management System:

• • Establishment and continuous implementation of a documented quality management system detailing necessary process steps.
  • Control of all quality documents and records, ensuring their accuracy and currency.
  • Maintenance of records for a period not less than 2 years from the date of production (or longer if the product has a shelf life).

• Human Resources and Training:

• • Defined roles and responsibilities for personnel affecting product quality.
  • Adequate and continuous training for personnel responsible for product and process quality, with maintained training records.

• Infrastructure and Working Environment:

• • Provision and maintenance of necessary infrastructure and control of the working environment to meet production requirements.
  • Documentation and implementation of hygiene, cleanliness, and dress code requirements for personnel involved in production.

Summary of Requirements for a Medical Device Factory:

• Factory Operation License: Legal authorization to operate a medical device manufacturing unit.
• GMP Certificate: Compliance with Good Manufacturing Practices to ensure product quality.
• ISO 13485 Certification: International quality management system standard for medical devices.
• Product Registration Certificate: Approval of individual medical devices by the Thai FDA.

By ensuring compliance with these licensing requirements and quality standards, a medical device factory can be properly established and operated.

 

Announcement of the Ministry of Public Health regarding the Quality System of Medical Device Production, B.E. 256

Page 260 Volume 141, Special Section 4, Royal Gazette 5 January 2024

To ensure that medical equipment is produced with standardized quality, effectiveness, and safety for consumer protection, it is appropriate to establish a quality system for medical device production. By virtue of Section 5, paragraph one, and Section 2 (5) of the Medical Devices Act 2008, and with the advice of the Medical Devices Committee, the Minister of Public Health, Ronnasuk, hereby announces the following:

Effective Date This announcement shall come into force one hundred and eighty days after its publication in the Royal Gazette.

Article 2 Definitions

1. “Type 1 medical device” refers to devices that pose a low risk to individuals and public health or are low-noise equipment, as defined in the Ministry of Public Health’s announcement on medical equipment risk levels dated 14 November 2019 and its amendments.
2. “Type 2 medical devices” are those with medium risk to individuals or low risk to public health, as per the same announcement and amendments.
3. “Type 3 medical devices” include those with high risk to individuals or public health or medium to high risk devices, according to the same criteria.
4. “Type 4 medical devices” are high-risk devices to both individuals and public health, following the aforementioned announcement and amendments.

Article 3 Quality System Requirements The quality system for medical device production must adhere to one of the following standards:

1. Good criteria and methods for producing medical devices as per Appendix A attached to this announcement.
2. International Organization for Standardization (ISO) 13485:2016 (Medical devices – Quality management systems – Requirements for regulatory purposes).
3. National inspection and certification standards for medical equipment (M.T.C. 13485:2019).
4. Standards and requirements for medical device production as per Appendix B, effective until 31 December 2027.
5. Standards and requirements as per Appendix C.

Article 4 Quality System Implementation

1. For Type 1 medical devices: A quality system must adhere to standards in Article 3 (1), (2), or (5).
2. For Types 2, 3, and 4 medical devices: A quality system must comply with standards in Article 3 (1), (2), or (3).
3. For medical devices intended for animals: The quality system must meet standards in Article 3 (1), (2), (3), or (5).

If a production establishment produces multiple types of medical devices, it must follow the quality system for the highest risk category.

Article 5 Applicability to Existing Registrants

1. For Type 1 medical devices: A quality system must comply with Article 3 (1), (2), (3), or (5) from the effective date of this announcement.
2. For Type 2 medical devices: A quality system must comply with Article 3 (2) or (3) from the effective date, with temporary adherence to Article 3 (4) until 31 March 1986.
3. For Type 3 medical devices: A quality system must comply with Article 3 (1), (2), or (61) from the effective date, with temporary adherence to Article 3 (4) until 31 March 1986.
4. For Type 4 medical devices: A quality system must comply with Article 3 (1), (2), or (3) from the effective date.
5. For medical devices intended for animals: The quality system must comply with Article 3 (1), (2), (3), or (5) from the effective date.

For establishments producing multiple types of medical devices, adherence to the quality system for the highest risk category is required.

Article 6 Inspection and Evaluation Criteria Inspection and evaluation criteria shall follow the manual issued by the Food and Drug Administration (FDA).

Article 7 Authority and Compliance The Secretary-General of the FDA is responsible for enforcing this announcement. In case of any issues, the Secretary-General shall have the final decision-making authority.

Issued on 17 November 2023. Chonnan Srikaew Minister of Public Health

Appendix A: Criteria and Good Methods for Producing Medical Devices

• The quality management system must adhere to National Inspection and Certification Standards (M.T.C. 13485-2019) or future standards.

Appendix B: Standards and Requirements (Effective until 31 December 2027)

1. General Requirements
   • Manufacturers must document and implement a continuous quality management system for medical device production.
   • All quality documents must be controlled to ensure the correct and current versions are used.
   • Records must be stored for at least 2 years from the production date or more than 1 year past the product’s shelf-life.
2. Management Responsibility
   • Top management must establish a written quality policy, review it continuously, and communicate it to personnel.
   • Measurable quality objectives aligned with the quality policy must be set and monitored.
3. Human Resources
   • Personnel performing quality-impacting work must be qualified through education, training, skills, and experience, with continuous training and records maintained.
4. Basic Structure and Working Environment
   • Necessary infrastructure must be provided and maintained, with records kept.
   • The working environment must be controlled to meet product requirements, with documented standards for hygiene, cleanliness, and personnel attire.
5. Production and Service Operations
   • Manufacturers must plan and document production processes, ensuring products meet specified requirements.
   • Verification, traceability, and proper handling of customer assets must be documented and recorded.

Appendix C: Standards and Requirements for High-Risk Medical Devices

1. General Requirements
   • Manufacturers must document and continuously implement a quality management system.
   • Outsourcing processes must be controlled to ensure consistency with product risks.
2. Documentation and Human Resources
   • All quality documents and records must be controlled, ensuring accurate and current versions are used.
   • Personnel responsible for product quality must be adequately trained, with records maintained.
3. Basic Structure, Working Environment, and Purchasing
   • Necessary infrastructure and a controlled working environment must be provided and maintained.
   • Quality characteristics of purchased products must be specified and controlled through documented records.
4. Production and Service Operations
   • Detailed documentation of production processes and control conditions must be maintained to ensure product quality.

Effective date: One hundred and eighty days after publication in the Royal Gazette.

Chonnan Srikaew Minister of Public Health

 

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