Medical Devices Rules 2017 – 100 Important MCQs for Drug Inspector Exam Preparation [PDF Download]

If you’re preparing for the Drug Inspector Exam or any regulatory exam that covers medical device laws, the Medical Devices Rules, 2017 is one topic you can’t afford to skip. These rules, notified under the Drugs and Cosmetics Act, 1940, form the foundation for how medical devices are classified, manufactured, imported, labeled, and regulated in India.

In this post, we’ve summarized the 100 most important MCQs based on the official Medical Devices Rules, 2017—perfect for last-minute revision or concept-based learning.

Overview of Medical Devices Rules, 2017

The Medical Devices Rules (MDR), 2017, notified by the Ministry of Health and Family Welfare, came into force on 1st January 2018. These rules were designed to separate medical device regulation from drugs, ensuring safety, quality, and performance of medical devices sold or used in India.

Key highlights include:

• Risk-based classification (Class A, B, C, D)
• Licensing authorities at both Central and State levels
• Mandatory Quality Management System (QMS) compliance
• Import and labeling standards
• Clinical investigation and post-marketing surveillance provisions

Understanding the Medical Devices Rules, 2017 is more than just an exam requirement — it’s a vital skill for anyone entering the regulatory or compliance side of the pharmaceutical industry. These rules outline how India ensures the safety, quality, and traceability of every medical device in the market. A solid grasp of these concepts helps Drug Inspectors make informed decisions and uphold public health standards.

Why These MCQs Matter for Drug Inspector Exam

In most competitive exams like Drug Inspector, Pharmacist Officer, or Regulatory Affairs Officer, questions on Medical Devices Rules, 2017 appear every year. They test your understanding of:

• Device classification and definitions
• Licensing forms and authorities
• Import/export provisions
• Labeling and UDI (Unique Device Identification)
• Shelf life, testing, and post-market surveillance

To make your preparation simpler, we’ve compiled 100 concept-based MCQs directly from the official rules. Each question includes the correct answer and relevant rule reference.

Download: Medical Devices Rules 2017 – Important MCQs for Drug Inspector Exams (PDF)

You can download the complete set of 100 MCQs with answers and rule references below:

👉 Download PDF – Medical Devices Rules 2017 Important MCQs for Drug Inspector Exams

The PDF includes:

• 100 concept-based questions
• Chapter-wise rule references
• Clean layout for mobile and print revision

Sample Questions from Medical Devices Rules 2017

Q1. The Medical Devices Rules, 2017 came into full effect from which date?
Answer: 1st January 2018 (Rule 1)

Q15. What is the validity of a Notified Body registration certificate?
Answer: In perpetuity, with renewal every 5 years (Rule 13(7))

Q41. From which date was Unique Device Identification (UDI) made mandatory?
Answer: 1st January 2022 (Rule 46)

Q60. What is defined as a “serious adverse event” under these rules?
Answer: Any untoward occurrence causing death, life threat, or hospitalization (Rule 3(zq))

Study Tips

While memorizing MCQs is helpful, understanding the structure of the Rules—especially Chapters II (Regulation), IV (Manufacture), and V (Import)—is crucial. Most questions are derived directly from these sections.

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