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Subtopics in this bank
Medical Devices Rules 2017Premises & plantSchedule M (incl. revised 2024)
Sample questions, with the reasoning
Every served question is explained like this — including why each wrong option is wrong.
A Class C medical device is imported from a country other than Australia, Canada, Japan, European Union Countries or the United States of America. On what basis may the import licence be granted?
A)Without any clinical investigation, since a licence is granted on documents alone
B)On published safety and performance data from the country of origin
C)After safety and effectiveness has been established through clinical investigation in India✓
D)On a free sale certificate from the country of origin alone
Why C is correct
For Class C and Class D devices from non-listed countries, the licence may be granted after safety and effectiveness has been established through clinical investigation in India.
Source: Medical Devices Rules, 2017, Rule 36
Source cited
A clinical investigation of an investigational medical device is terminated. Within what period must the detailed reasons be communicated to the Central Licensing Authority?
A)Fourteen days of such termination
B)One year of such termination
C)Sixty days of such termination
D)Thirty days of such termination✓
Why D is correct
Condition (iv) requires that on termination of any clinical investigation the detailed reasons be communicated to the Central Licensing Authority within thirty days.
Source: Medical Devices Rules, 2017, Rule 53
Source cited
A device functions only when connected to a mains electrical supply. Under the definitions, this makes it an "active medical device" because its operation depends on:
A)Gravity or stored mechanical energy
B)A source of energy that supplies information for detecting or diagnosing a condition
C)A source of electrical energy or any other source of energy other than energy generated by the human or animal body or gravity✓
D)Any source of energy whatsoever, including energy generated by the human body
Why C is correct
The definition turns on dependence on an external energy source, expressly excluding energy generated by the human or animal body or gravity.
Source: Medical Devices Rules, 2017, Rule 3
Source cited
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