Process for Managing Post-Approval Changes : Regulatory Solutions India
The process for managing post-approval changes in medical devices includes the following steps:
1. Identification of Changes: The first step is to identify any changes that have been made to the device. This may involve conducting an impact assessment to determine whether the changes are major or minor.
2. Notify and obtain approval from the Licensing Authority: If any major changes have been made to the device, the manufacturer/ importer must notify the licensing authority and obtain approval before implementing the changes. The notification must include details of the changes, such as the reason for the change and supporting documents.
2. Notify and obtain approval from the Licensing Authority: If any major changes have been made to the device, the manufacturer/ importer must notify the licensing authority and obtain approval before implementing the changes. The notification must include details of the changes, such as the reason for the change and supporting documents.
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