Section 26(iii) in The Medical Devices Rules, 2017
(iii)the licence holder shall obtain prior approval from the Central Licensing Authority or the State Licensing Authority, as the case may be, before any major change as specified in the Sixth Schedule is carried out and the Central Licensing Authority or the State Licensing Authority, as the case may be, shall indicate its approval or rejection within forty five days and in case where no communication is received within the stipulated time from such Authority, such change shall be deemed to have been approved;
