Qualification and Experience: For Technical Staff in Medical Devices

Last Updated on January 18, 2025 by The Health Master

Qualification and Experience

As per Rule 22 of the Medical Devices Rules 2017, the essential qualifications and experience of the technical staff required for the manufacturing and testing of Medical Devices are as follows:

Technical staff for manufacturing of Medical Devices:

Technical staff under whose direction and supervision the manufacturing activity of a medical device shall be undertaken, and such staff shall possess the following educational qualifications and experience:

(a) degree in engineering (in relevant branch) or in pharmacy or in science in appropriate subject from a recognised University and shall have experience of not less than two years in manufacturing or testing of medical devices; or

b) diploma in engineering (in relevant branch) or in pharmacy from a recognised institute and shall have the experience of not less than four years in manufacturing or testing of medical devices.

Technical staff for testing of Medical Devices:

Technical staff with a degree or diploma in engineering (in relevant branch) or in pharmacy or in science in relevant subject and having experience of not less than two years in testing of medical devices under whose direction and supervision the testing activity of a medical device shall be undertaken.

Discussion on experience:

There should be no doubt about the experience of technical staff, which is as under:

For manufacturing:

Degree: The technical staff having a degree as mentioned above in para (a) must have experience of not less than two years in manufacturing or testing of Medical Devices.

Diploma: The technical staff having a diploma, as mentioned above in para (b) must have experience of not less than four years in manufacturing or testing of Medical Devices.

For testing:

Degree or diploma: The technical staff having a degree or diploma as mentioned above must have experience not less than two years in testing of Medical Devices.

Qualification and experience at a glance:

Activity for Medical Devices	Qualification	Experience not less than	Medical Devices experience in
Manufacturing	Degree	2 Years	Manufacturing or testing
	Diploma	4 years	Manufacturing or testing
Testing	Degree	2 years	Testing
	Diploma	2 Years	Testing

Discussion on qualification:

It is clear that pharmacy means degree or diploma in pharmacy, but what about the degree or diploma in engineering in relevant branch or science in an appropriate subject on relevant subject ?

Let’s discuss the degree or diploma in science in the appropriate subject on the relevant subject.

As per the various advertisements by the Department of Health and Family Welfare, Ministry of Health and Family Welfare, Govt. of India for the vacancy of regulators for Medical Devices, we can come to the conclusion that science in appropriate subject on relevant subject means as under:

Science in appropriate subject on relevant subject means the following:

• Bio Chemistry or
• Chemistry or
• Life Sciences
• Medicine with Clinical Pharmacology or
• Microbiology or
• Pharmaceutical Sciences

Engineering in the relevant branch means engineering in the following branches:

• Bio Medical Engineering or
• Bio Technology or
• Chemical Engineering or
• Computer Science Engineering or
• Electrical Engineering or
• Electronics Engineering or
• Instrumentation Engineering or
• Mechanical Engineering or
• Medical Electronics Engineering or
• Polymer Engineering

All qualifications (degree or diploma) alphabetically are as under:

• Bio Chemistry or
• Bio Medical Engineering or
• Bio Technology or
• Chemical Engineering or
• Chemistry or
• Computer Science Engineering or
• Electrical Engineering or
• Electronics Engineering or
• Instrumentation Engineering or
• Life Sciences
• Mechanical Engineering or
• Medical Electronics Engineering or
• Medicine with Clinical Pharmacology or
• Microbiology or
• Pharmaceutical Sciences or
• Pharmacy or
• Polymer Engineering

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Compiled by:
Rakesh Dahiya, SDCO cum Licensing Authority, FDA Haryana

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