Central Government made rules on 4th and 7th Schedules of MDR 2017 for insertion of e-IFU

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 theDrugs Technical Advisory Board, hereby makes rulesfurther to amend the Medical Devices Rules, 2017.