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TYPES OF POST-APPROVAL CHANGES
Post-approval changes in medical devices can be classified into two categories:major changes and minor changes.
Major Changes
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Major changes refer to any changes that have a significant impact on the device's performance, quality, safety, or effectiveness.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 font type/size, color, design
• Manufacturing processes, equipment, or testing affecting the quality
• Primary packaging material
If any major changes are made to the device, the manufacturer/Importer must notify the licensing authority and obtain approval before implementing the changes.
The changes in medical devices must be approved or rejected by the central licensing authority within 45 days, otherwise the changes are deemed approved.
Minor Changes
Minor changes refer to any changes that do not have a significant impact on the device's performance, quality, safety, or effectiveness.These changes include:
• Design which does not affect quality in respect of its specifications.
Indications for use, performance and stability of the medical device
• Manufacturing processes, equipment, or testing which does not affect quality of the device.
• Packaging specifications excluding primary packaging material.
If any minor changes are made to the device, the manufacturer must inform the licensing authority within 30 days of implementing the changes. However, prior approval from the licensing authority is not required for minor changes.
