1
Seat No.: Enrolment
GUJARAT TECHNOLOGICAL UNIVERSITY
BE SEMESTER-VIII EXAMINATION WINTER 2018
Subject Code: 2180307 Date: 26/11/2018
Subject Name: Regulatory Standards for Medical Devices
Time: 02:30 PM TO 05:00 PM Total Marks: 70
Instructions:
1. Attempt all questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
MARKS
Q.1

How are devices determined to belong to the higher risk group?
03

Give definition of medical device according to US FDA and ISO 13485.
04

Give the categorization of medical devices according to ISO 10993.
07
Q.2

What are some of the devices that are provided in combination with drugs?
03

What are the driving forces behind the development of the medical device?
04

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

Give the classification based on Singapore medical device norms.
07
Q.3

How can a medical device improve the quality of life?
03

Explain functions of DGCI and central government for medical device regulation.
04

Explain organization of CDSCO.
07
OR
Q.3

Which Indian organization recently prices of coronary stents? Why?
03

Whether Registration and import license is required for import of non-notified medical device in India? Justify the answer.
04

Write a short note on medical device regulatory in India.
07
Q.4

Explain the safety aspect of cyber-security during the designing of Medical Devices.
03

Draw regulatory process chart for Class I EU medical devices.
04

Explain the main eight principles of Quality Management Systems for Medical Devices (ISO 13485:2003) with the help of diagram.
07
OR
Q.4

Explain the role of Competent Authority members in EU.
03

Define the following terms 1. Labeling 2. Post-Marketing
04

Explain the process of China Compulsory Certification Mark in detail.
07
Q.5

Define the following terms with examples.
Surface Contacting Devices External Communicating Devices
03

Enlist the functions undertaken by the FDA and state government for Medical Device regulation in India.
04

Define CE Marking? Outline the steps to achieve the CE marking for medical device in EU.
07
OR
Q.5

Is there a single entity that controls all the different regulatory authorities in the different countries? Justify the answer.
03

Illustrate the difference between Manufacturing-Related Regulation and Clinical Trial-Related Regulation
04

Describe the regulatory process of Class II Class III US-FDA Medical devices with the help of flowchart.
07