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Change Control (Post approval change)

Change Control (Post approval change)

Indian Medical Device Rule -2017

Change Control (Post approval change)

As per Sixth Schedule of the Indian Medical Device Rule - 2017, there are two kind of changes

  1. Major Change

  2. Minor Change

  1. Manjor Change:

    Changes in respect of following shall be considered as major change in:

    1. material of construction;

    2. design which shall affect quality in respect of its specifications, indication for use; performance and stability of the

      medical device;

    3. the intended use or indication for use ;

    4. the method of sterilization;

    5. the approved Shelf life;

    6. the name or address of,

      1. the domestic manufacturer or its manufacturing site;

      2. overseas manufacturer or its manufacturing site (for import only);

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