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 –

• These rules will be called as the Medical Device  under (…..Amendment) Rules, 2021
• These rules will come into force on the date of their final publication in the Official Gazette of India.
• According to rule 46 of Drugs and Cosmetic Act, 1945 . 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

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