As part of a significant update to the Thai FDA’s regulatory framework, new change notification guidelines were issued, effective 15 January 2025. These changes impact both in vitro diagnostic (IVD) and non-IVD devices, particularly focusing on the processes for adding/removing models within the same product grouping and amending information related to the importer or domestic manufacturer on device labels and Instructions for Use (IFU).

Key Updates

The update essentially withdraw the previous change notification topic concerning the addition and removal of devices within a registered grouping and introduces specific categories for each case, allowing amendments to the grouping.

Class 1 Change Notification Topics:

1. To add or remove a List of Medical Devices (Models):
   • Applicable to add or remove devices within the same certificate under an amended grouping.
2. Addition to List of Medical Devices (Models):
   • Applicable to add models within the same certificate, where the product grouping may be amended.
3.  Withdrawal List of Medical Devices (Models):
   • Models’ withdrawal from the same certificate, with amendments made to the product grouping.
4. Amendment in Importer or Domestic Manufacturer’s Information (on Label and IFU):
   • Allows changes to the Thai importer (for imported devices) or Thai manufacturer (for domestically manufactured devices) as shown on the device label and IFU.

Document Requirements for Class 1 Change Notification

Class 2-4 Change Notification Topics:

1. Addition of List of Medical Devices (Models):
   • Category: Major Change.
   • Required Documentation: 16 documents.
2. Withdrawal of List of Medical Devices (Models):
   • Category: Minor Change.
   • Required Documentation: 1 document.
3. Amendment in Importer or Domestic Manufacturer’s Information (on Label and IFU):
   • Category: Minor Change.
   • Required Documentation: 1 document.

Class 2-4 IVD and Non-IVD Devices Guidelines: Adding and Removing Items/Models

Device Type: IVD Devices

• Case 1: Adding a list of medical devices.
  • Example: Adding reagents or analyzers under the grouping of IVD cluster, which is not included in the accessories list.
• Case 2: Adding devices of the same design (e.g., changes in quantity or permissible variants within the family grouping).
  • Example: Adding a new lot or batch based on repackaging of the registered device, where the primary packaging remains unchanged, increasing package sizes, or adding models with variations allowed within the permissible family grouping.
• Case 3: Adding devices or software that do not impact performance characteristics or specifications.
  • Example: Adding a modified lot for ergonomic purposes or a new software version without affecting safety/performance.
• Case 4: Adding accessories to the main device.
  • Example: Adding diluent tubes or accessories (Class 1) included in the approved IFU of the device.

Device Type: Non-IVD Devices

• Case 1: Adding a list of medical devices.
  • Example: Adding foam adhesives for diabetic or chronic wounds, grouped as a single device with new sizes.
• Case 2: Adding devices of the same design (e.g., changes in quantity or permissible variants within the family grouping).
• Case 3: Adding devices or software that do not impact performance characteristics or specifications.
• Case 4: Adding accessories to the main device.
  • Example: Adding accessories (Class 1) included in the approved IFU of the device.

Class 2 – 4 Updated Required Documentation Breakdown

Important Considerations

1. Declaration Letter for Optional Documents: If no significant changes have been made to the documents, Thai FDA will require a "Declaration Letter for Required Document Attachments with No Significant Changes." (Thai FDA template)
2. Device Registration Pathway Compliance: If the device was registered under a specific pathway (e.g., Abridged Evaluation), the models being added must comply with that pathway. Exempted documents from initial registration do not need to be submitted; a letter of declaration is required instead.

Conclusion: Key Impacts of the Updated Thai FDA Change Notification Guidelines

• Class 1 devices: Simplified process, requiring fewer documents for model withdrawal and amendments to importer/manufacturer details.
• Class 2-4 devices: More extensive documentation required for model additions, reflecting stricter safety and regulatory standards.
• Label/IFU updates: Constant and more efficient method for updating local importer/manufacturer information, reducing documentation.
• For manufacturers: Sensible navigation of updated guidelines is essential to ensure compliance, avoid delays, and ensure smooth product registration and change notifications.

Contact Us

If you need assistance with navigating the updated Thai FDA regulations or require guidance on your medical device change notifications, please reach out to us. Our expert team is ready to support you in ensuring full compliance with the new regulatory framework.

Qualtech Consulting Corporation has been a trusted partner for medical device manufacturers for over 25 years. Whether you’re a local startup or an international player, we empower your devices to enhance lives.

Connect with us today here to unlock your medical device potential.

References:

• The Medical Device Control Division has updated the change notification system, effective from 15 January 2025.
• Guidelines for submitting a change notification request under the topic "Addition/Removal of Medical Device Items" for IVD (in vitro diagnostic) medical devices (Class 2-4).
• Guidelines for submitting a change notification request under the topic "Addition/Removal of Medical Device Items" for non-IVD (non in vitro diagnostic) medical devices (Class 2-4)