This news deals with the latest Amendment which has been published by the CDSCO. The CDSCO has released a new Amendment in the Drugs and Cosmetics Act, 1945 with Notification number S.O.877(E) published on 23rd December,2021.The Draft rules for amendment are as follows –
1 (i) These rules will be called as the Medical Device under (…..Amendment) Rules, 2021
(ii) These rules will come into force on the date of their final publication in the Official Gazette of India.
2. According to rule 46 of Drugs and Cosmetic Act, 1945
(i) In Medical Device rule,2017 for rule no 46 the following will be substituted as follows:
Unique device identification in medical devices — With effect from the date as may be specified by the Central Government, a medical device, approved for manufacture for sale or distribution or import, shall bear unique device identification in the manner as may be determined.
Note: The Medical Devices Rules, 2017 was published in the Official Gazette vide notification number G.S.R. 78(E), dated the 31st January, 2017 and last amended on 23rd December, 2021
Morulaa HealthTech as successful regulatory consultants and experts in Indian MDR to our clients. We have delivered high level professionalism and quality towards our clients. We at Morulaa can help you learn more about the Indian MDR. Subscribe to our Website for Indian MDR wherein you learn about the Latest Rules and Indian MDR. Contact Morulaa for additional Consultation or information on Indian MDR.
