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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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