Download GTU BE/B.Tech 2019 Summer 8th Sem New 2180307 Regulatory Standards For Medical Devices Question Paper

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GUJARAT TECHNOLOGICAL UNIVERSITY
BE - SEMESTER-VII(NEW) EXAMINATION - SUMMER 2019

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Instructions:

1. Attempt all questions.

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2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.

MARKS

Q.1

1. What are examples of medical devices? 03

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2. Explain the Safety testing of Medical Devices. 04
3. What are some of the devices that are provided in combination with drugs? 07

Q.2

1. Draw the Organization Chart of CDSCO. 03
2. Explain the role of below given members in EU. 1) Competent Authority 2) Notified Body. 04

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3. Explain the main eight principles of Quality Management Systems for Medical Devices (ISO 13485:2003) with the help of diagram. 07

OR

1. Is there a single entity that controls all the different regulatory authorities in the different countries? Justify the answer. 07

Q.3

1. Explain the categorization of medical device based on ISO 10993. 03

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2. What are the functions undertaken by DCGI and Central Government for medical Device regulation? 04
3. Define CE Marking? Outline the steps to achieve the CE marking for medical device in EU. 07

OR

1. Explain the safety aspect for cyber-security. 03
2. Enlist the functions undertaken by the FDA and state government for Medical Device regulation in India 04

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3. Explain Life cycle of medical devices from research and development until regulatory approval. 07

Q.4

1. Give Classification of IVD Devices. 03
2. Indicate the ISO Standards for below define task. 04
   1. Quality management
   2. Risk Management

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   3. Biological Evaluation
   4. Clinical Trials
3. Discuss the technical material and labeling requirement of medical devices in India. 07

OR

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1. What is the Role of CDRH department in Medical Device Regulation? 03
2. Define the following terms with examples. 1) Surface Contacting Devices 2) External Communicating Devices. 04
3. Whether Registration and import license is required for import of nonnotified medical device in India? Justify the answer. 07

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Q.5

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1. What are the necessary requirements for Premarket Notification 510K Submission for Medical Device? 04
2. Describe the regulatory process of Class II & Class III US-FDA Medical devices with the help of flowchart. 07

OR

1. Write a note on classification of medical devices in EU. 03
2. Write a Short note on : CCC Mark ( China Compulsory Certification Mark) 04

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3. Illustrate the difference between Manufacturing-Related Regulation and Clinical Trial-Related Regulation. 07

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