MCQ with answers
Medical Devices Rules, 2017
10 explained questions below · 264 on this instrument in the practice banks · Rules as amended, including the 2020 amendment extending registration to all devices.
The Medical Devices Rules, 2017 took medical devices out of the general drug rules and gave them their own risk-based regime, in force from 1 January 2018. The organising idea is classification: every device is placed in Class A (low risk) to Class D (high risk), and the class decides who licenses it — the State Licensing Authority for the lower classes, the Central Licensing Authority for the higher ones — and how much evidence the application must carry.
Around that spine sit the parts examiners return to: the definitions and the classification rules, the manufacturing and import licence forms, the quality management system a manufacturer must run, the labelling requirements, the clinical investigation and performance evaluation provisions, and the audit role of notified bodies. The Rules are also the sole technical head of the UPSC Drugs Inspector (Medical Devices) recruitment test, which is why this bank cites the exact rule on every MDR question.
The questions below are shared with the Medical Devices wing, where every rule-cited item carries its supporting quotation.
What the exams keep asking
- ▸Definitions and the four risk classes A–D
- ▸Which licensing authority handles which class — State versus Central
- ▸Manufacture and import licence forms and their conditions
- ▸Quality management system and the role of notified bodies
- ▸Labelling of medical devices
- ▸Clinical investigation and clinical performance evaluation
10 practice questions, each explained
Attempt first, then open the answer. Every explanation says why the right option is right — and, where the bank holds it, quotes the provision.
- Question 1EASY
Orders of suspension issued or revoked, or cancellation of a licence, must be:
- A)Published only after the appeal period has expired
- B)Published in the Official Gazette only
- C)Communicated only to the licensee concerned
- D)Duly published on the concerned websites of the licensing authority
Show answer & explanation
Answer: D) Duly published on the concerned websites of the licensing authority
Such orders shall be duly published on the concerned websites of the State Licensing Authority or the Central Licensing Authority, as the case may be.
Why the others fail
- A) No such deferral of publication is provided.
- B) The rule specifies website publication, not the Gazette.
- C) The rule requires public publication, not merely private communication.
Source: Medical Devices Rules, 2017, Rule 30 —
duly published on the concerned websites of the State Licensing Authority or
Source citedfrom the Drug Inspector bank - Question 2EASY
What information is required to be disclosed about persons involved in clinical investigation?
- A)Only the names of the principal investigators
- B)The names, addresses and other particulars of persons involved
- C)Only their professional qualifications
- D)Their remuneration and contractual terms
Show answer & explanation
Answer: B) The names, addresses and other particulars of persons involved
The provision requires disclosure of the names, addresses and other particulars of persons involved in clinical investigation.
Why the others fail
- A) The obligation is broader than names and is not confined to principal investigators.
- C) Qualifications are not the particulars specified for disclosure here.
- D) Financial terms are not among the particulars named in the provision.
Source: Medical Devices Rules, 2017, Rule 58 —
the names, addresses and other particulars of persons
Source citedfrom the Drug Inspector bank - Question 3EASY
In which Form is an application made to the Central Licensing Authority for an import licence for test, evaluation, demonstration or training?
- A)Form MD-16
- B)Form MD-14
- C)Form MD-29
- D)Form MD-15
Show answer & explanation
Answer: A) Form MD-16
A person desiring to import a medical device for test, evaluation, demonstration or training applies to the Central Licensing Authority in Form MD-16 with the fee specified in the Second Schedule.
Why the others fail
- B) MD-14 is the application for grant of an ordinary import licence.
- C) MD-29 relates to prior permission for an investigational or new in vitro diagnostic medical device.
- D) MD-15 is the form in which an import licence is granted.
Source: Medical Devices Rules, 2017, Rule 40 —
the Central Licensing Authority in Form MD-16, accompanied by such fee as specified in the Second Schedule.
Source citedfrom the Drug Inspector bank - Question 4EASY
A non-invasive medical device comes into contact with injured skin and is intended to be used as a mechanical barrier, for compression, or for absorption of exudates only, for wounds which have not breached the dermis and can heal by primary intention. It is classified as:
- A)Class D
- B)Class C
- C)Class A
- D)Class B
Show answer & explanation
Answer: C) Class A
Rule 1(i)(a) assigns Class A to such a device where the wound has not breached the dermis and heals by primary intention.
Why the others fail
- A) Class D is not assigned to non-invasive devices under this parameter.
- B) Class C applies where the wound has breached the dermis and cannot heal by primary intention.
- D) Class B applies where the wound has breached the dermis or the device manages the wound microenvironment.
Source: Medical Devices Rules, 2017, Rule 1 —
for compression or for absorption of exudates only, for wounds which have not
Source citedfrom the Drug Inspector bank - Question 5EASY
As per the classification Basic Principles in the First Schedule, software which drives a medical device or influences its use is classified as:
- A)Classified separately as an accessory
- B)Always Class A regardless of the device it drives
- C)Automatically falling in the same class as the device it drives or influences
- D)Classified only after a separate risk assessment distinct from the device
Show answer & explanation
Answer: C) Automatically falling in the same class as the device it drives or influences
The Basic Principles state that software which drives or influences use of a device falls automatically in the same class as that device.
Why the others fail
- A) Accessories are classified separately, but software driving/influencing a device is expressly treated differently — it follows the device's class.
- B) No fixed default class is stated for such software; it follows the device's own class.
- D) No separate risk assessment is mentioned; classification is automatic and tied to the device.
Source: Medical Devices Rules, 2017, Rule 97 —
Software, which drives a device or influences the use of a device, falls
Source citedfrom the Drug Inspector bank - Question 6EASY
For how long must data, records, registers and other documents be maintained by a person holding a permission under this Chapter of the Medical Devices Rules, 2017?
- A)Seven years after completion of the investigation
- B)One year from the date of grant of permission
- C)Three years after completion of the investigation
- D)Five years after completion of the investigation
Show answer & explanation
Answer: A) Seven years after completion of the investigation
Rule 57 requires retention of data, records, registers and other documents for seven years after completion of the investigation.
Why the others fail
- B) One year from grant is the deadline for enrolling the first participant under rule 53.
- C) The rule fixes seven years, not three.
- D) A plausible but incorrect retention period; the rule says seven years.
Source: Medical Devices Rules, 2017, Rule 57 —
maintain such data, record, registers and other documents for a period of seven
Source citedfrom the Drug Inspector bank - Question 7EASY
If satisfied that the requirements of the Medical Devices Rules, 2017 have been complied with, the Central Licensing Authority grants permission to conduct clinical investigation for an investigational medical device in which form?
- A)Form MD-22
- B)Form MD-23
- C)No form is prescribed; a letter suffices
- D)The form specified by the State Licensing Authority
Show answer & explanation
Answer: B) Form MD-23
Rule 52(i) requires the permission for clinical investigation of an investigational medical device to be granted in Form MD-23.
Why the others fail
- A) MD-22 is the application form, not the grant of permission.
- C) The rule expressly prescribes a form for the permission.
- D) The State Licensing Authority has no role in granting this permission.
Source: Medical Devices Rules, 2017, Rule 52 —
grant permission to conduct clinical investigation for an investigational medical
Source citedfrom the Drug Inspector bank - Question 8EASY
Where there are reasons to believe that a medical device already placed in the market may be unsafe for patients, the manufacturer or authorised agent shall:
- A)Immediately inform the competent authority and cooperate with them
- B)Inform the competent authority only after the withdrawal is complete
- C)Inform only the hospitals holding stock of the device
- D)Take no step unless a patient injury has actually occurred
Show answer & explanation
Answer: A) Immediately inform the competent authority and cooperate with them
Where there are reasons to believe a marketed device may be unsafe for patients, the manufacturer or authorised agent must immediately inform the competent authority and cooperate with them.
Why the others fail
- B) Information is required immediately, not deferred until withdrawal ends.
- C) The obligation runs to the competent authority, not merely to stockists.
- D) The trigger is reason to believe the device may be unsafe, not proof of actual harm.
Source: Medical Devices Rules, 2017, Rule 89 —
inform the competent authority and cooperate with them, if there are reasons to
Source citedfrom the Drug Inspector bank - Question 9EASY
An application by a purchaser for test or evaluation of a medical device is to be made in which form?
- A)A plain written request, no form being prescribed for a purchaser
- B)Form MD-33
- C)Form MD-32
- D)The same form in which the report of the test is later supplied
Show answer & explanation
Answer: B) Form MD-33
The rule directs that a purchaser's application for test or evaluation of a medical device or portion thereof shall be made in Form MD-33.
Why the others fail
- A) The rule prescribes a specific form for the purchaser's application.
- C) MD-32 is the form in which the report of such test is supplied to the applicant.
- D) Application and report are made in different prescribed forms under this rule.
Source: Medical Devices Rules, 2017, Rule 69 —
Form MD-33 and the report of such test or evaluation of the medical device
Source citedfrom the Drug Inspector bank - Question 10EASY
In respect of sale of medical devices, which body of provisions is applied mutatis mutandis?
- A)Part VI of the Drugs and Cosmetics Rules, 1945 relating to sale of drugs other than homeopathic medicines
- B)The provisions relating to registration of medical device testing laboratories
- C)The provisions of the Drugs and Cosmetics Rules, 1945 relating to homeopathic medicines
- D)No provisions of the Drugs and Cosmetics Rules, 1945 apply to sale of medical devices
Show answer & explanation
Answer: A) Part VI of the Drugs and Cosmetics Rules, 1945 relating to sale of drugs other than homeopathic medicines
Subject to these rules, Part VI relating to sale of drugs other than homeopathic medicines under the Drugs and Cosmetics Rules, 1945 applies mutatis mutandis to the sale of medical devices.
Why the others fail
- B) Laboratory registration governs testing, not sale; it is a different subject matter.
- C) The Part applied is expressly the one for drugs other than homeopathic medicines.
- D) Sale of medical devices is expressly governed by borrowed provisions, not left unregulated.
Source: Medical Devices Rules, 2017, Rule 87 —
Part VI relating to “Sale of Drugs Other than Homeopathic
Source citedfrom the Drug Inspector bank
Practise the full set with real marking
These 10 are a fixed sample. The practice engines serve the whole bank — shuffled, scored the way the exam scores, explanation after every answer.
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