UPSC Prelims Practice Questions — Centre seeks to ease licensing process for medical devices

Q1. Under the Union Health Ministry's 2026 draft amendment to the Medical Devices Rules, 2017, the timeline for grant of a manufacturing licence for Class B medical devices is proposed to be reduced to how many days?

  • A. 90 days
  • B. 105 days
  • C. 115 days
  • D. 140 days

Q2. In the risk-based classification of medical devices retained in the 2026 draft amendment, which single class comprises the highest-risk devices such as heart valves and implantable defibrillators?

  • A. Class A
  • B. Class B
  • C. Class C
  • D. Class D

Q3. The Medical Devices Rules, 2017 — which the 2026 draft seeks to amend to ease licensing — are framed under which one of the following statutes?

  • A. The Drugs and Cosmetics Act, 1940
  • B. The Clinical Establishments (Registration and Regulation) Act, 2010
  • C. The National Medical Commission Act, 2019
  • D. The Pharmacy Act, 1948

Q4. With reference to the changes proposed by the Union Health Ministry's 2026 draft amendment to the Medical Devices Rules, 2017 as compared to the existing timelines, consider the following statements: 1. The manufacturing-licence timeline for Class A devices is proposed to be reduced from 105 days to 90 days. 2. The manufacturing-licence timeline for Class B devices is proposed to be reduced from 140 days to 115 days. 3. For Class C and Class D devices, the period for grant of licence after receipt of the inspection report is proposed to be reduced from 60 days to 30 days. Which of the statements given above is/are correct?

  1. The manufacturing-licence timeline for Class A devices is proposed to be reduced from 105 days to 90 days.
  2. The manufacturing-licence timeline for Class B devices is proposed to be reduced from 140 days to 115 days.
  3. For Class C and Class D devices, the period for grant of licence after receipt of the inspection report is proposed to be reduced from 60 days to 30 days.
  • A. 1 and 2 only
  • B. 1 and 3 only
  • C. 2 and 3 only
  • D. 1, 2 and 3

Q5. Which one of the following is the apex regulatory body that issued the 2026 draft amendment and acts as the Central Licensing Authority for grant of manufacturing licences to higher-risk (Class C and D) medical devices?

  • A. Central Drugs Standard Control Organisation (CDSCO)
  • B. National Pharmaceutical Pricing Authority (NPPA)
  • C. Indian Council of Medical Research (ICMR)
  • D. National Medical Commission (NMC)