Indian Medical Device regulations MCQs With Answer

Introduction: Indian Medical Device regulations MCQs With Answer is designed for M.Pharm students preparing for advanced studies and professional roles in clinical research and regulatory affairs. This set focuses on the Medical Device Rules and regulatory practices in India, explaining device classification, approval pathways, clinical investigation requirements, quality systems, labeling, post-market surveillance and roles of regulatory authorities. The questions are crafted to deepen conceptual understanding and application of regulatory principles, not just rote memorization, helping students evaluate real-world scenarios they may encounter in industry, CROs or regulatory submissions. Each MCQ is followed by the correct answer to support efficient self-assessment and targeted revision.

Q1. Which regulation primarily governs medical devices in India?

• The Medical Device Rules, 2017
• The Pharmacy Act, 1948
• The Food Safety and Standards Act, 2006
• The Drugs and Cosmetics Act, 1940 only

Correct Answer: The Medical Device Rules, 2017

Q2. How are medical devices classified under Indian regulations?

• By risk into Classes A, B, C and D
• By price into Affordable and Premium
• By manufacturing country into Domestic and International
• By distribution channel into Retail and Institutional

Correct Answer: By risk into Classes A, B, C and D

Q3. Which body is the central authority responsible for regulating medical devices in India?

• Central Drugs Standard Control Organization (CDSCO)
• Pharmacy Council of India (PCI)
• Indian Council of Medical Research (ICMR)
• National Pharmaceutical Pricing Authority (NPPA)

Correct Answer: Central Drugs Standard Control Organization (CDSCO)

Q4. Which class of medical devices generally requires the most stringent regulatory controls and clinical evidence?

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

Correct Answer: Class D

Q5. For which type of devices is a clinical investigation most likely required before regulatory approval in India?

• Novel high-risk implantable devices (Class D)
• Low-risk consumables (Class A)
• Standard surgical instruments with established use
• Off-the-shelf medical furniture

Correct Answer: Novel high-risk implantable devices (Class D)

Q6. Which international standard is widely accepted for conducting clinical investigations of medical devices?

• ISO 14155 — Clinical investigation of medical devices for human subjects
• ISO 9001 — Quality management systems
• IEC 60601 — Medical electrical equipment safety
• ISO 14971 — Risk management for medical devices

Correct Answer: ISO 14155 — Clinical investigation of medical devices for human subjects

Q7. Which quality management standard is most relevant for medical device manufacturers internationally?

• ISO 13485 — Medical devices — Quality management systems
• ISO 9000 — Generic quality fundamentals
• ISO 14001 — Environmental management
• ISO 27001 — Information security management

Correct Answer: ISO 13485 — Medical devices — Quality management systems

Q8. What is the primary purpose of post-market surveillance for medical devices?

• To detect, monitor and mitigate adverse events and safety risks after market entry
• To increase device sales through marketing
• To reduce production costs by changing materials without reporting
• To transfer regulatory responsibility to distributors only

Correct Answer: To detect, monitor and mitigate adverse events and safety risks after market entry

Q9. Who is responsible for reporting adverse events related to a medical device in the supply chain?

• Manufacturer, importer and authorised representative as applicable
• Only the end user
• Only the retailer selling the device
• Only the clinical investigator conducting a study

Correct Answer: Manufacturer, importer and authorised representative as applicable

Q10. Which element is NOT typically required on the label of a medical device?

• Retail price printed on the primary label for regulatory purposes
• Intended use or indications
• Manufacturer name and address
• Batch/lot number or serial number

Correct Answer: Retail price printed on the primary label for regulatory purposes

Q11. What is the key regulatory intent of Unique Device Identification (UDI) systems?

• Improve traceability and enable rapid identification during recalls and surveillance
• Replace device manuals with online advertising
• Lock devices to a single hospital to prevent resale
• Ensure all devices are manufactured in the same country

Correct Answer: Improve traceability and enable rapid identification during recalls and surveillance

Q12. Which document or approval is generally required before initiating a clinical investigation of a high-risk device in India?

• Regulatory approval from CDSCO and ethics committee clearance
• Only local hospital management consent
• A marketing authorisation from any foreign regulator
• Only a manufacturer’s internal approval

Correct Answer: Regulatory approval from CDSCO and ethics committee clearance

Q13. Which activity is a primary component of risk management for medical devices?

• Identification, evaluation and control of hazards throughout the device lifecycle
• Only testing finished product performance once a year
• Marketing assessment to determine customer preferences
• Reducing manufacturing costs regardless of safety impacts

Correct Answer: Identification, evaluation and control of hazards throughout the device lifecycle

Q14. What does “Notified Medical Device” imply under Indian regulations?

• A device explicitly categorized by the regulator as a medical device for regulatory control
• A device that has been advertised on television
• A device sold only through notified retail chains
• A device exempted from all regulatory requirements

Correct Answer: A device explicitly categorized by the regulator as a medical device for regulatory control

Q15. Which of the following best describes a “legacy device” in the context of regulatory transition?

• A device already marketed before implementation of new regulatory requirements that may need retroactive registration
• A device that is manufactured solely for research and not for sale
• A device designed specifically for veterinary use
• A prototype not intended to enter the market

Correct Answer: A device already marketed before implementation of new regulatory requirements that may need retroactive registration

Q16. Which stakeholder is expected to maintain a quality management system and device traceability records?

• Manufacturer (or authorised representative where applicable)
• Only the end user or patient
• Only retail pharmacies selling the device
• Only the courier delivering the device

Correct Answer: Manufacturer (or authorised representative where applicable)

Q17. What is an essential consideration when submitting a regulatory dossier for a Class C medical device?

• Comprehensive evidence including design, risk analysis, performance data and clinical evidence proportional to risk
• Only a photograph of the device and company brochure
• A marketing plan showing projected sales
• Proof of exclusive distributor agreements

Correct Answer: Comprehensive evidence including design, risk analysis, performance data and clinical evidence proportional to risk

Q18. Why is conformity assessment important in medical device regulation?

• To demonstrate that device design and manufacturing comply with applicable standards and regulatory requirements
• To ensure the device is the cheapest option on the market
• To provide discounts to bulk purchasers
• To determine the marketing slogans for the device

Correct Answer: To demonstrate that device design and manufacturing comply with applicable standards and regulatory requirements

Q19. Which practice strengthens ethical conduct and patient protection during device clinical investigations?

• Independent ethics committee review, informed consent and subject safety monitoring
• Publishing results only after marketing authorisation
• Allowing device manufacturers to directly recruit without oversight
• Providing incomplete risk information to speed enrolment

Correct Answer: Independent ethics committee review, informed consent and subject safety monitoring

Q20. How does post-market vigilance benefit public health with respect to medical devices?

• By enabling early detection of device-related problems and facilitating corrective regulatory actions
• By eliminating the need for pre-market evaluation
• By increasing device prices through compliance costs
• By reducing manufacturer responsibility after sale

Correct Answer: By enabling early detection of device-related problems and facilitating corrective regulatory actions

Download