Thailand: Thai FDA released a draft Ministry of Public Health Announcement on the Quality System to Produce Medical Devices B.E.

In the interest of consumer protection and to ensure the quality, efficiency, and safety of medical device production, the Thai FDA released a draft public health announcement and guideline to establish a quality system for producing medical devices on 19 July 2023. Should the final announcement and guideline be approved and released, effectivity would be after 120 days from the date of its publication in the Royal Gazette.

The quality system to produce medical devices includes one of the following:

1. Compliance with the criteria and good practices to produce medical devices in accordance with the requirements of the National Standards for Medical Device Inspection and Certification – Quality Management System – Guidelines for Regulatory Oversight, MS. 13485-2562, or as subsequently announced.
2. Compliance with the international organization standard for medical device standards – Quality Management System – Guidelines for Regulatory Oversight ISO 13485:2016 (Medical devices – Quality management system – Requirements for regulatory purposes – ISO 13485:2016), or as subsequently announced.
3. Compliance with the national inspection and certification standards for medical devices – Quality Management System – Guidelines for Regulatory Oversight, MS. 13485-2562, or as subsequently announced.
4. Compliance with the standards and specifications to produce medical devices attached to the announcement of the Ministry of Public Health, effective until December 31, 2027
5. Compliance with the standards and specifications to produce medical devices attached to the announcement of the Ministry of Public Health.

The control of quality management systems to produce medical devices is enforced differently based on the risk classification of the medical devices (Class A-D and veterinary medical devices). In the case of manufacturing establishments producing medical devices of various types, they must comply with quality management systems for medical devices of higher-risk categories.

The guideline to produce medical devices attached to the announcement of the Ministry of Public Health are categorized as follows: 

1. Quality management system 
2. Management responsibility 
3. Resource management
4. Manufacturing
5. Inspection, Testing, and Corrective Action

Requirements to produce medical devices are attached at the end of the announcement of the Ministry of Public Health are categorized as follows:

1. General requirements
2. Documentation requirements
3. Human resources
4. Infrastructure 
5. Work environment
6. Requirements related to the product (The manufacturer shall define)
7. Purchasing
8. Production and service – General Requirements
9. Identification 
10. Storage and Distribution of Products
11. Inspection and testing of product
12. Control of non-conforming product

For further information on this announcement, click here.

If you have any queries regarding this announcement, please contact us or click the button below.