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Post Approval Changes

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Post Approval Changes

Post approval changes are part of device life cycle. these are the changes that are made to the devices once they have received CDSCO license to manufacture or import for sale or distribution in India. These changes can occur due to a number of reasons; however, these changes are to be evaluated on basis of whether they will affect the safety and performance of devices.

The changes are classified as Major and Minor, where major changes will require prior approval from the regulatory body i.e. CDSCO and minor changes shall be notified to CDSCO.

As per the Indian Medical Device Rule, 2017; the major and minor changes are mentioned below:

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Major Changes

  • Change in material of construction
  • Change to design which shall affect quality in respect of its specifications, indication for use; performance and stability of the medical device;
  • Change to the intended use or indication for use;
  • Change to the method of sterilization;
  • Change to the approved Shelf life;
  • Change in the name or address of

    • the domestic manufacturer or its manufacturing site;
    • overseas manufacturer or its manufacturing site (for import only);
    • authorised agent (for import only);
  • Changes to label excluding change in font size, font type, color, label design;
  • Changes to manufacturing process, equipment or testing which shall affect quality of the device;
  • Changes to primary packaging material.

Minor Changes

  • Changes to design which shall not affect quality in respect of its specifications, indication for use, performance and stability of the medical device;
  • Changes to in the manufacturing process, equipment, or testing which shall not affect quality of the device;
  • Changes to packaging specifications excluding primary packaging material.

Maven Profcon Services LLP, has a team of consultants who can assist you in implementing the post approval changes as well as get approval for the same and notifying the authority of these changes. We make the process hassle-free for you.

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