INTRODUCTION

The introduction of a medical device into the market is a complex process that starts with necessary approval from the licensing authority. Once a device has been approved, any changes made to it can potentially impact its performance, quality, safety, and effectiveness.To address this issue, the central government has included a provision in the sixth schedule of the Medical Device Rules (2017) that requires all post-approval changes in medical devices to be communicated to the licensing authority.

WHAT ARE POST-APPROVAL CHANGES IN MEDICAL DEVICES?

Post-approval changes in medical devices refer to any modifications or alterations made to a device or to any of the manufacturing steps after an import license has been issued by CDSCO.These changes may include modifications to the device's design, manufacturing processes, intended use, or indication for use. Any such changes have the potential to affect the device's performance, quality, safety, and effectiveness.Therefore, it is crucial to manage these changes effectively to ensure that the device continues to meet regulatory requirements.