Can I request any change in Thai FDA Medical Device License after it has been released?
Medical device regulation in Thailand is overseen by the Thai Food and Drug Administration (FDA), which ensures the safety, quality, and efficacy of medical devices circulating within the country. Obtaining a medical device license in Thailand is a crucial step for manufacturers wishing to market their products in the region. However, once the license is secured, there may arise situations where amendments to the license are necessary. These changes could range from alterations in manufacturing processes to modifications in labeling requirements. Understanding the process of post-license amendments is essential for manufacturers to maintain compliance with Thai FDA regulations.
The Thai FDA categorizes medical devices into four classes, ranging from Class 1 (low risk) to Class 4 (high risk), along with in vitro diagnostic (IVD) devices. Regardless of the device class, manufacturers may need to request amendments to their licenses due to various reasons such as changes in manufacturing facilities, modifications in device specifications, or updates in labeling requirements.
Here are some common amendments that manufacturers may need to request post obtaining the Thai FDA Medical Device License:
- Change in Manufacturer: Manufacturers might need to amend the license to reflect changes in the physical manufacturer of the device while keeping the legal manufacturer or product owner unchanged. This could include alterations in the manufacturer’s name or production location.
- Revision of Instructions for Use: Amendments may be required to update or add new instructions for use, especially in cases where there are changes in device design or specific characteristics.
- Software Changes: For active medical devices involving software, modifications in software functionalities may necessitate amendments to the license.
- Changes in Principle Ingredients or Components: Alterations in the primary ingredients or components of the medical device, including changes in sourcing or manufacturing processes of biological materials, may require license amendments.
- Specific Device Requirements: Amendments may be necessary to modify specific requirements associated with the medical device.
- Changes in Packaging: Modifications in primary packaging or sterile primary packaging that impact the device’s quality may require amendments.
- Manufacturing Process Changes: Amendments might be needed for alterations in manufacturing processes that affect the device’s safety and effectiveness.
- Sterilization Facilities: Changes related to sterilization facilities, including additions, reductions, or alterations in sterilization methods, may necessitate amendments.
- Owner Information Updates: Changes in the legal owner’s name or address without altering the manufacturer’s location may require amendments.
- Product Labeling Revisions: Amendments may be necessary for changes in labeling or packaging details that do not impact the device’s overall safety or effectiveness.
In details, these are the possible amendment in Thai FDA Medical Device License:
- To amend the physical manufacturer of the medical device in a foreign country while retaining the original product owner, such as changing the manufacturer’s name or production location.
- To amend approved or add new instructions for use, such as changes in design characteristics or specific features of the medical device.
- To amend instructions for use due to changes in software for active medical devices.
- To amend the principal ingredients or components of the medical device by changing types, sources, or manufacturing processes of biological materials, including cells, tissues, and/or derivatives of animal, human, microbial, or recombinant origin without changing the intended use of the biological materials.
- To amend the principal ingredients or components of the medical device by changing raw materials used in manufacturing or changing suppliers of raw materials for manufacturing the medical device.
- To amend specific requirements of the medical device.
- To amend by adding or reducing the list of medical devices in the same group.
- To amend by increasing the shelf life or reducing the intensity level for storing medical devices or changing the storage conditions of medical devices.
- To amend the primary packaging that affects the quality of the medical device or sterile primary packaging.
- To amend manufacturing processes that affect the effectiveness and safety of the medical device, such as changes in manufacturing processes that result in changes to the specific requirements of the medical device.
- To amend by adding/reducing/changing sterilization facilities without changing the sterilization process that ensures sterility.
- To amend manufacturing processes that affect the effectiveness and safety of the medical device, such as changes in sterilization methods.
- To amend the name or address of the product owner without changing the manufacturer’s location in a foreign country.
- To amend the name of the manufacturer in a foreign country without changing the location, such as when the foreign manufacturer changes its company name due to mergers or acquisitions.
- To amend by reducing the shelf life or increasing the intensity level for storing.
- To amend labels or documents for medical devices without affecting the overall effectiveness or safety of the medical device, such as changing colors, adding/removing/changing formats, images, symbols, barcodes, changing packaging sizes, or changing text without altering the overall meaning.
- To amend labels or documents for medical devices to enhance safety in using the medical device.
- To amend product codes while keeping the same medical device.
- To amend the software of the medical device, specifically for modifications that do not affect the effectiveness and safety of the medical device.
- Amendments to the details table of medical device listings or accessories due to printing errors.
These amendments in Thai FDA Medical Device License play a vital role in ensuring that medical devices comply with evolving regulatory standards and maintain their safety and efficacy profiles. Manufacturers must adhere to the Thai FDA’s guidelines and procedures when requesting these amendments to avoid any disruptions in the marketing of their products.
In conclusion, navigating the process of post-license amendments for medical device licenses in Thailand is critical for manufacturers to remain compliant with regulatory requirements. By understanding the potential changes and following the necessary procedures outlined by the Thai FDA, manufacturers can effectively manage modifications to their licenses and ensure continued market access for their medical devices.
Other articles on medical Device Regulation:
Thai FDA Medical Device: Understanding the Impact of Partial 2 Submission Termination
Criteria for group classification of medical devices in Thailand
