UPSC Prelims Practice Questions — Centre moves to simplify medical device regulations

Q1. In the regulation of medical device manufacture in India, the 'loan licence' — the requirement of which for outsourced sterilisation has recently been dispensed with — refers to which one of the following?

  • A. A licence granted to an importer permitting temporary import of medical devices for demonstration or exhibition, subject to re-export within a stated period
  • B. A provisional licence granted to every new manufacturing site for the entire period until a notified body completes its quality management system audit
  • C. A licence granted to an applicant who intends to manufacture a medical device on the premises of another manufacturer already holding a licence
  • D. A licence granted to a manufacturer permitting it to lend its surplus production capacity to any other manufacturer for a fixed term

Q2. The requirement that the licence number of an outsourced sterilisation site be disclosed on a medical device's label was cleared, before its notification, on the recommendation of which one of the following?

  • A. The Drugs Consultative Committee, whose prior concurrence is required for every amendment to rules framed under the Drugs and Cosmetics Act, 1940
  • B. The Drugs Technical Advisory Board, the statutory expert body that advises the Central Government on technical matters arising under the Drugs and Cosmetics Act, 1940
  • C. The National Medical Devices Promotion Council under the Department for Promotion of Industry and Internal Trade, Ministry of Commerce and Industry
  • D. The Medical Device Technical Advisory Group, which alone can clear all labelling changes proposed for notified medical devices in India

Q3. With reference to the waiver of clinical investigation for medical devices under Rule 63 of the Medical Devices Rules, 2017, consider the following statements: 1. Japan is among the jurisdictions already recognised for the purpose of granting such a waiver. 2. The waiver route is meant for a device for which no predicate device is available in India. 3. The European Union is proposed to be added to the list of recognised jurisdictions. 4. Brazil and the Republic of Korea are among the jurisdictions already recognised for this purpose. Which of the statements given above is/are correct?

  1. Japan is among the jurisdictions already recognised for the purpose of granting such a waiver.
  2. The waiver route is meant for a device for which no predicate device is available in India.
  3. The European Union is proposed to be added to the list of recognised jurisdictions.
  4. Brazil and the Republic of Korea are among the jurisdictions already recognised for this purpose.
  • A. 1 and 3 only
  • B. 2 and 4 only
  • C. 1, 2 and 3
  • D. 1, 3 and 4

Q4. Prior to the amendment proposed in 2026, the following were the jurisdictions whose regulatory approval could dispense with a fresh clinical investigation for a medical device in India: 1. Canada 2. Switzerland 3. Australia 4. Singapore Which of the above is/are NOT correctly identified as such a jurisdiction?

  1. Canada
  2. Switzerland
  3. Australia
  4. Singapore
  • A. 1 and 3 only
  • B. 2 and 4 only
  • C. 1, 2 and 4
  • D. 3 only

Q5. Consider the following statements regarding the legal basis of the Medical Devices Rules, 2017: 1. They were framed in exercise of the rule-making power conferred by the Drugs and Cosmetics Act, 1940. 2. Though notified in January 2017, they came into force only on 1 January 2018. 3. They were notified by the Ministry of Chemicals and Fertilizers, which administers the Central Drugs Standard Control Organisation. 4. They were enacted as a standalone parliamentary statute that displaced the regulation of devices as drugs. Which of the above is/are NOT correct?

  1. They were framed in exercise of the rule-making power conferred by the Drugs and Cosmetics Act, 1940.
  2. Though notified in January 2017, they came into force only on 1 January 2018.
  3. They were notified by the Ministry of Chemicals and Fertilizers, which administers the Central Drugs Standard Control Organisation.
  4. They were enacted as a standalone parliamentary statute that displaced the regulation of devices as drugs.
  • A. 1 and 2
  • B. 3 and 4
  • C. 2 and 3 only
  • D. 4 only

Q6. As stated by the Union Health Ministry, how many Central Medical Device Testing Laboratories have been designated for the testing and evaluation of medical devices?

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

Q7. Which one of the following heads the Central Drugs Standard Control Organisation and is the authority empowered to approve new drugs and permit clinical trials in India?

  • A. The Chairman of the National Pharmaceutical Pricing Authority under the Department of Pharmaceuticals
  • B. The Director of the Central Drugs Laboratory, Kolkata, the statutory appellate testing authority under the Drugs and Cosmetics Act, 1940
  • C. The Drugs Controller General (India), functioning under the Directorate General of Health Services in the Health Ministry
  • D. The Chairman of the Drugs Technical Advisory Board, the statutory expert body constituted under the Drugs and Cosmetics Act, 1940

Q8. Consider the following statements about the Central Drugs Standard Control Organisation (CDSCO): 1. It functions under the Ministry of Health and Family Welfare and regulates the quality, safety and performance of notified medical devices. 2. It became an Affiliate Member of the International Medical Device Regulators Forum in 2024. 3. Notified bodies registered with it carry out quality management system audits of Class C and Class D manufacturing units. 4. Licensing of Class A and Class B medical devices is done exclusively by the Central Licensing Authority, State authorities having no role in it. Which of the above is/are NOT correct?

  1. It functions under the Ministry of Health and Family Welfare and regulates the quality, safety and performance of notified medical devices.
  2. It became an Affiliate Member of the International Medical Device Regulators Forum in 2024.
  3. Notified bodies registered with it carry out quality management system audits of Class C and Class D manufacturing units.
  4. Licensing of Class A and Class B medical devices is done exclusively by the Central Licensing Authority, State authorities having no role in it.
  • A. 1 and 2
  • B. 2 and 3 only
  • C. 3 and 4
  • D. 1 and 4 only

Q9. Consider the following statements regarding the risk-based classification of medical devices in India: 1. Devices are placed in Class A, B, C and D on the basis of associated risk, in line with Global Harmonization Task Force practice. 2. Only Class D devices are treated as high-risk, Classes A, B and C all being treated as low-risk. 3. In April 2025, a revised risk-based classification list covering cardiovascular and neurological devices was placed in the public domain for comments. 4. Risk-based licensing of Class A and Class B medical devices became operative with effect from 1 October 2020. Which of the statements given above is/are correct?

  1. Devices are placed in Class A, B, C and D on the basis of associated risk, in line with Global Harmonization Task Force practice.
  2. Only Class D devices are treated as high-risk, Classes A, B and C all being treated as low-risk.
  3. In April 2025, a revised risk-based classification list covering cardiovascular and neurological devices was placed in the public domain for comments.
  4. Risk-based licensing of Class A and Class B medical devices became operative with effect from 1 October 2020.
  • A. 1, 2 and 3
  • B. 2 and 4
  • C. 3 and 4 only
  • D. 1 and 3 only