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Roll No. | Total No. of Questions : 06 |
Total No. of Pages : 01 |
M.Pharmacy(Regulatory Affairs) (2017 Batch) (Sem.-2)
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REGULATORY ASPECTS OF MEDICAL DEVICES
Time: 3 Hrs. | Subject Code : MRA-203T |
M.Code: 74939 |
INSTRUCTIONS TO CANDIDATES :
- Attempt any FIVE questions out of SIX questions.
- Each question carries FIFTEEN marks.
Max. Marks: 75
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- a) Classify Medical Devices. (10)
b) Discuss IVDs. (5) - Explain in detail the validation and verification of Medical devices. (15)
- Write notes on the following :
- Unique device identification as per US FDA. (8)
- Pre-marketed approval as per US FDA. (7)
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- Discuss the major highlights for the devices and in vitro diagnostics as per European Union? (15)
- Discuss in detail the process for clinical investigation and evaluation of medical devices in relation to Asian Continent? (15)
- Write notes on the following :
- Summary Technical Documents. (5)
- Good Clinical Practice for Medical devices. (10)
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NOTE : Disclosure of Identity by writing Mobile No. or Making of passing request on any page of Answer Sheet will lead to UMC against the Student.
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