SIXTH SCHEDULE [Refer rules 26(iii), 26(iv), 38(v)...

SIXTH SCHEDULE [Refer rules 26(iii), 26(iv), 38(v) and 38(vii)] POST APPROVAL CHANGE (A) 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, — (i) the domestic manufacturer or its manufacturing site; (ii) overseas manufacturer or its manufacturing site (for import only); (iii) authorised agent (for import only); 7. label excluding change in font size, font type, color, label design; 8. manufacturing process, equipment or testing which shall affect quality of the device; 9. primary packaging material. (B) Changes in respect of following shall be considered as minor change in, — 1. design which shall not affect quality in respect of its specifications, indication for use, performance and stability of the medical device; 2. in the manufacturing process, equipment, or testing which shall not affect quality of the device; 3. packaging specifications excluding primary packaging material.