UPSC Prelims Practice Questions — Union Ministry of Health and Family Welfare Proposes Amendments to Medical Devices Rules, 2017 to Promote Ease of Doing Business

Q1. Consider the following statements regarding the regulatory regime introduced by the Medical Devices Rules, 2017 as compared with the position obtaining before them: 1. The 2017 Rules did away with third-party conformity assessment and instead made a pre-licensing inspection of every manufacturing site by officers of the drug regulator compulsory for all classes of devices. 2. Before these Rules, medical devices in India were regulated as "drugs" under the Drugs and Cosmetics Act, 1940, with individual devices being notified for regulation. 3. The Rules came into force on 1 January 2018 and introduced a four-tier risk-based classification that the earlier device-by-device regime did not have. Which of the statements given above is/are correct?

  1. The 2017 Rules did away with third-party conformity assessment and instead made a pre-licensing inspection of every manufacturing site by officers of the drug regulator compulsory for all classes of devices.
  2. Before these Rules, medical devices in India were regulated as "drugs" under the Drugs and Cosmetics Act, 1940, with individual devices being notified for regulation.
  3. The Rules came into force on 1 January 2018 and introduced a four-tier risk-based classification that the earlier device-by-device regime did not have.
  • A. 1 and 2 only
  • B. 1 and 3 only
  • C. 2 and 3 only
  • D. 1, 2 and 3

Q2. Under the Medical Devices Rules, 2017, devices belonging to how many of the four risk classes have been exempted — in their non-sterile and non-measuring form — from the requirement of obtaining a manufacturing or import licence?

  • A. One
  • B. Two
  • C. Three
  • D. Four

Q3. The placing of a medical device in Class A, B, C or D under the Medical Devices Rules, 2017 is determined by which one of the following?

  • A. The essentiality of the device as listed in the National List of Essential Medicines by the Health Ministry
  • B. The annual turnover of the manufacturing unit as declared to the State Licensing Authority concerned
  • C. The level of invasiveness of the device as certified by an accredited Notified Body in its audit report
  • D. The risk associated with the device, following Global Harmonization Task Force practice

Q4. Consider the following statements about the treatment of different risk classes of devices under the Medical Devices Rules, 2017: 1. Class A (low risk) — the manufacturing licence is granted without a prior audit of the manufacturing site, on the manufacturer's self-certification of compliance. 2. Class B (low moderate risk) — the manufacturing site is subject to a Quality Management System audit by an accredited Notified Body. 3. Class C (moderate high risk) — the manufacturing licence is granted by the State Licensing Authority, the Central Licensing Authority acting only as an appellate authority. 4. Class D (high risk) — manufacture is regulated by the Central Licensing Authority, which may take the assistance of experts or notified bodies where required. Which of the above is/are NOT correct?

  1. Class A (low risk) — the manufacturing licence is granted without a prior audit of the manufacturing site, on the manufacturer's self-certification of compliance.
  2. Class B (low moderate risk) — the manufacturing site is subject to a Quality Management System audit by an accredited Notified Body.
  3. Class C (moderate high risk) — the manufacturing licence is granted by the State Licensing Authority, the Central Licensing Authority acting only as an appellate authority.
  4. Class D (high risk) — manufacture is regulated by the Central Licensing Authority, which may take the assistance of experts or notified bodies where required.
  • A. 1 and 3
  • B. 2 and 4
  • C. 1, 2 and 4
  • D. 3 only

Q5. Consider the following statements about the Central Drugs Standard Control Organisation (CDSCO): 1. It is the National Regulatory Authority for drugs, medical devices and cosmetics in India. 2. Accreditation of the Notified Bodies that audit medical device manufacturers is carried out by CDSCO itself. 3. It is a subordinate office of the Directorate General of Health Services, an attached office of the Department of Health and Family Welfare. 4. It holds full voting membership of the International Medical Device Regulators Forum. Which of the above is/are NOT correct?

  1. It is the National Regulatory Authority for drugs, medical devices and cosmetics in India.
  2. Accreditation of the Notified Bodies that audit medical device manufacturers is carried out by CDSCO itself.
  3. It is a subordinate office of the Directorate General of Health Services, an attached office of the Department of Health and Family Welfare.
  4. It holds full voting membership of the International Medical Device Regulators Forum.
  • A. 1 and 3
  • B. 2 and 4
  • C. 3 only
  • D. 2, 3 and 4

Q6. As stated by the Union Health Ministry, how many laboratories has CDSCO registered for carrying out testing and evaluation of medical devices on behalf of manufacturers?

  • A. Two
  • B. Four
  • C. Nine
  • D. Fourteen

Q7. The Health Ministry's draft amendment to the Medical Devices Rules, 2017 prescribes clearly defined timelines for how many distinct stages of the manufacturing-licence process?

  • A. Two
  • B. Three
  • C. Four
  • D. Six

Q8. Which one of the following was the principal change proposed in the Health Ministry's draft amendment to the Medical Devices Rules, 2017?

  • A. Doing away entirely with the Quality Management System audit requirement for every class of medical device
  • B. Shifting the licensing of Class C and Class D devices wholly from the Central to the State Licensing Authorities
  • C. Rationalising the timelines for grant of manufacturing licences across the different risk categories of devices
  • D. Replacing the risk-based classification with a single uniform licensing category for all medical devices

Q9. Of the roughly 4,100 licensed medical device manufacturers in India, the number licensed for manufacture of Class B devices is closest to:

  • A. 343
  • B. 1,123
  • C. 2,099
  • D. 2,560

Q10. With effect from 1 October 2022, licences for the manufacture of Class A and Class B medical devices are granted by which one of the following?

  • A. The State Licensing Authority of the State concerned
  • B. The Central Licensing Authority at CDSCO headquarters
  • C. The National Accreditation Board for Certification Bodies
  • D. The National Pharmaceutical Pricing Authority

Q11. The Cabinet-approved National Medical Devices Policy, 2023 is to be implemented through strategies covering how many broad areas?

  • A. Four
  • B. Five
  • C. Six
  • D. Eight

Q12. Consider the following statements about the recent amendments to the New Drugs and Clinical Trials Rules, 2019: 1. The licensing requirement for manufacture of drugs for non-commercial purposes has been replaced by a prior-intimation mechanism, expected to save at least 90 days in the drug development life cycle. 2. Where a test licence continues to be applicable, the statutory processing timeline has been brought down from 90 days to 45 days. 3. The requirement of obtaining prior permission has been dispensed with for all bioavailability and bioequivalence studies, irrespective of the risk involved. Which of the statements given above is/are correct?

  1. The licensing requirement for manufacture of drugs for non-commercial purposes has been replaced by a prior-intimation mechanism, expected to save at least 90 days in the drug development life cycle.
  2. Where a test licence continues to be applicable, the statutory processing timeline has been brought down from 90 days to 45 days.
  3. The requirement of obtaining prior permission has been dispensed with for all bioavailability and bioequivalence studies, irrespective of the risk involved.
  • A. 1 and 2 only
  • B. 1 and 3 only
  • C. 2 and 3 only
  • D. 1, 2 and 3