Last Updated on November 11, 2025 by The Health Master
Qualifications
The Ministry seeks a crucial amendment to the Medical Device Rules (MDR), 2017, concerning the qualifications expected from those in charge of inspections and analyses of medical devices.
An amendment will be made only to propose specific qualifications for Medical Device Inspectors and Government Analysts.
Thus, the Ministry’s notification of a draft amendment to MDR, 2017, outlines that these rules will become effective after 30 days from the notification date and seeks objections and suggestions from the public and stakeholders during that period.
Objections and suggestions
- 30-day Rule: The draft rules will be considered after 30 days of publication, meaning if any objections or suggestions come through during those 30 days, the draft rules may be modified before consideration.
- Feedback Loop: The Ministry also opened the floor for objections and suggestions from the general public and stakeholders within that time period.
Once the MDR, 2017 draft suggestions are confirmed and posted, the final rules will come into play when published in the Official Gazette.
Specific qualifications for Medical Device Inspectors and Government Analysts, introducing Rule 18A and Rule 18B, will be added immediately following Rule 18 of the MDR, 2017, to specifically outline the educational qualifications of these specialized positions for government employment and are necessary to keep compliance standards within the industry.
Rule 18A: Qualification of the Medical Device Inspector
The draft suggests that a qualified person must possess one of the following degrees from a university or institute recognized by relevant Indian authorities:
Bachelor of Engineering / Bachelor of Technology in:
- Biomedical Engineering
- Chemical Engineering
- Mechanical Engineering
- Electrical Engineering
- Electronics Engineering
- Instrumentation Engineering
- Biotechnology
- Polymer Science
- Computer Science
- Medical Electronics Engineering
OR
Bachelor’s degree in:
- Pharmacy or Pharmaceutical Science
- Microbiology
- Biochemistry
- Chemistry
- Life Sciences
This aligns with what was previously discussed in the 2024 recruitment rules by CDSCO for Medical Device Officers; aligning such qualifications throughout all Medical Device Regulatory Bodies in India promotes consistency in standards.
Rule 18B: Qualifications of the Government Analyst for Medical Devices
The same previously discussed qualifications will be extended to the Government Analysts the individuals who test devices on behalf of the government.
The same specifications as listed above for both Government Analysts and Medical Device Inspectors emphasize that anyone who tests or examines medical devices must have similar specialized degrees, which promote consistent qualification levels.
Q: Why does the Ministry seek to amend the Medical Device Rules, 2017?
A: To increase competent personnel responsible for quality and safety enforcement since those with proper educational backgrounds will be appointed as Medical Device Inspectors or Government Analysts, thus, product quality will be assumed since those in charge will have bachelor’s degrees, all with specialized training at leading institutions across India.
Q: Why does the Ministry seek to amend the Medical Device Rules, 2017?
A: To increase competent personnel responsible for quality and safety enforcement since those with proper educational backgrounds will be appointed as Medical Device Inspectors or Government Analysts, thus, product quality will be assumed since those in charge will have bachelor’s degrees, all with specialized training at leading institutions across India.
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