The Ministry of Health and Family Welfare (MoHFW) on September 30, 2022, notified the Medical Devices (Fifth Amendment) Rules, 2022 will further amend the Medical Devices Rules, 2017.
The following amendments have been made-
•In the said rules, after rule 87, the following rules shall be inserted.
87A. Registration certificate to sell, stock, exhibit, or offer for sale or distribute a medical device including in vitro diagnostic medical device.
87B. Conditions of registration certificate to sell, stock, exhibit, or offer for sale or distribute a medical device including in vitro diagnostic medical device.
87C. Validity of registration certificate.
87D. Suspension and cancellation of Registration Certificate.
•In the said rules, in rule 88, in sub-rule (1), after the words “retail or wholesale”, the words, letters, and figures “or registration certificate in Form MD-42” shall be inserted.
•In the said rules, in the Second Schedule, shall be amended.
•After Form MD-40 Form MD-41 Application for Grant of Registration Certificate to Sell, Stock, Exhibit or Offer for Sale or Distribute a Medical Device Including in Vitro Diagnostic Medical Device, shall be inserted.
These rules shall come into force on the date of their publication in the Official Gazette.
[Notification No.G.S.R.754(E)]
