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Gujarat Technological University

This document is an exam for a course on regulatory standards for medical devices. It contains 5 questions asking students about various topics related to medical device regulation. Question 1 asks about the definition and need for medical device regulation, and the roles of the DGCI and CDSCO in India. Question 2 covers classification of medical devices and the drivers of medical device development. Question 3 discusses notified bodies, quality management systems, and definitions and classifications of medical devices. Question 4 addresses harmonization of regulations globally and specific regulatory processes like CE marking, FDA requirements, and China's compulsory certification mark. Question 5 defines some medical device terms, clinical trials regulation in India, and post-marketing regulation.

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53 views2 pages

Gujarat Technological University

This document is an exam for a course on regulatory standards for medical devices. It contains 5 questions asking students about various topics related to medical device regulation. Question 1 asks about the definition and need for medical device regulation, and the roles of the DGCI and CDSCO in India. Question 2 covers classification of medical devices and the drivers of medical device development. Question 3 discusses notified bodies, quality management systems, and definitions and classifications of medical devices. Question 4 addresses harmonization of regulations globally and specific regulatory processes like CE marking, FDA requirements, and China's compulsory certification mark. Question 5 defines some medical device terms, clinical trials regulation in India, and post-marketing regulation.

Uploaded by

vifaket581
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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Seat No.: ________ Enrolment No.

___________

GUJARAT TECHNOLOGICAL UNIVERSITY


BE - SEMESTER–VII (NEW) EXAMINATION – WINTER 2021
Subject Code:3170313 Date:15/12/2021
Subject Name:Regulatory Standards for Medical Devices
Time:10:30 AM TO 01:00 PM Total Marks: 70
Instructions:
1. Attempt all questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
4. Simple and non-programmable scientific calculators are allowed.

MARKS
Q.1 (a) What is medical device regulation? Why it should be 03
regulated?
(b) What are the functions of DGCI? 04
(c) What are the functions of CDSCO? 07

Q.2 (a) What are some of the devices that are provided in 03
combination with drugs?
(b) What are the driving forces behind the development of the 04
medical device?
(c) Classify medical devices on the basis of risk. 07
OR
(c) Write a short on labeling and its requirement. 07
Q.3 (a) What is notified body? How it works? 03
(b) What is QMS and QA in medical device regulation? 04
(c) Write medical device definition and give classification 07
of medical device according to medical device rules-
2017 India.
OR
Q.3 (a) How are devices determined to belong to the higher risk 03
group?
(b) Give the categorization of medical devices according to 04
ISO 10993.
(c) Explain Life cycle of medical devices from research and 07
development until regulatory approval.
Q.4 (a) Is there a single entity that controls all the different 03
regulatory authorities in the different countries? Justify the
answer.
(b) Enlist the functions undertaken by the FDA and state 04
government for Medical Device regulation in India
(c) Explain the process of China Compulsory Certification 07
Mark in detail.
OR
Q.4 (a) Define CE Marking? Outline the steps to achieve the CE 03
marking for medical device in EU.
(b) Give definition of medical device according to US FDA 04
and ISO 13485.

1
(c) Explain the main eight principles of Quality 07
Management Systems for Medical Devices (ISO
13485:2003) with the help of diagram.
Q.5 (a) Define the following terms with examples. 03
1) Surface Contacting Devices 2) External
Communicating Devices
(b) What is clinical trial regulation in India? 04
(c) Explain post-marketing related regulation in India. 07
OR
Q.5 (a) What is testing laboratory? Is there any regulatory body 03
for establishment of testing laboratory? Justify answer.
(b) Discuss role of distributers or local subsidiaries. 04
(c) Discuss the rules and regulations for import-export of 07
medical devices in India.

*************

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