The DCGI’s direction came after a gazette notification vide G.S.R. 19(E) issued by the Union ministry of health and family welfare on January 15, 2019 to amend the Medical Devices Rules, 2017.

Now, therefore, in exercise of the powers conferred by section 12 read with section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board, hereby makes rules further to amend the Medical Devices Rules, 2017.