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Medical Devices (Amendments) Rules 2022

Published on September 22, 2022
Current Context: The Government of India (GoI) notified the new Medical Devices Rules as the Medical Devices (Amendment) Rules, 2022.
Medical Devices (Amendments) Rules 2022
  • According to the Rules, all class ‘A’ medical device manufacturers have to register themselves through an online portal established for the purpose.
  • According to the 1st Schedule of the Rules, the manufacturer will be required to give an undertaking stating that the proposed device is a class A medical device (non-sterile and/or non-measuring).
  • The Rules further stated that the importer of medical devices will have to give an undertaking too, stating that the proposed device is a class A medical device.
  • The records of manufacturing, import, along with sales, and distribution will have to be maintained by both, the manufacturer and the importer.
  • Class ‘A’ medical devices (Nasopharyngeal Catheter, Umbilical Occlusion Device, Alcohol Swabs, etc.) are those with low-to-moderate risk to the patients.

Question:

Q.1 According to the Medical Devices (Amendment) Rules, 2022, the manufacturer and the importer will be required to give an undertaking for?
a. Class A Medicinal Device
b. Class B Medicinal Device
c. Class C Medicinal Device
d. Class D Medicinal Device
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