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