Understanding Post-Approval Changes in Medical Devices: A Comprehensive Guide
Introduction:
Medical devices are subject to continuous change, which is an essential part of the development process. Sometimes, after the approval of the licensing authority, changes are made to the medical device to improve its performance, quality, safety, and effectiveness. These changes are known as Post-Approval Changes in Medical Devices. This guide will provide an overview of the process of post-approval changes in medical devices.
The Types of Post-Approval Changes:
There are two types of post-approval changes in medical devices — major changes and minor changes.
Major Changes:
Major changes are those that have a significant impact on the performance, quality, safety, and effectiveness of the device. These changes include:
- Material of construction
- Design affecting the quality
- Intended use or indication for use
- Sterilization method
- Approved shelf life
- Name or address of licensee or manufacturer
- Labeling excluding fonts, color, design
- Manufacturing processes, equipment, or testing affecting the quality
- Primary packaging material
The manufacturer must inform the licensing authority about any major changes made to the device. The changes can be implemented only after receiving approval from the licensing authority. If the communication is not received within the stipulated time, the change is deemed approved.
Minor Changes :
Minor changes, on the other hand, do not have a significant impact on the performance, quality, safety, and effectiveness of the device. These changes include:
- Design
- Manufacturing processes, equipment, or testing
- Packaging specifications excluding primary packaging material.
For minor changes, there is no need to take prior approval from the licensing authority, but the manufacturer must inform the licensing authority within 30 days of implementation. The manufacturer must also update records, as necessary, in the plant master file, device master file, and design history file.
Conclusion:
Post-approval changes in medical devices are a critical aspect of the development process. Manufacturers must be aware of the types of changes and the process for notifying the licensing authority about the changes. It is essential to ensure that the changes made to the device do not have a significant impact on its performance, quality, safety, and effectiveness. By following the guidelines provided in this guide, manufacturers can make necessary changes to improve the device while ensuring compliance with regulations.
About Regulatory Solutions India
Regulatory Solutions India has a team of experienced regulatory consultants who can assist you in implementing post-approval changes and obtaining approval from the licensing authority. By working with our team, you can ensure compliance with regulations while making necessary changes to improve the device’s performance, quality, safety, and effectiveness.
Don’t hesitate to contact us to discuss your regulatory needs and how we can assist you.
