Game Changer For Biomedical & Life Sciences Graduates – Medical Device Inspector Qualifications Revised

Ministry of Health and Family Welfare (MoHFW) has released Big Opportunities for  Life Science & Tech Graduates!

India is set to strengthen the medical device regulations as the Ministry of Health and Family Welfare (MoHFW) has released a draft notification – GSR 748 (E) on October 10, 2025, proposing new amendments to reinforce the Medical Device Rules, 31st January, 2017. Medical Devices are the backbone of the modern Healthcare industry, as they play a significant role in public healthcare. They help in the accurate diagnosis and monitoring of the health of the patients and deliver effective treatments. From life-saving ventilators to health tracking monitors, medical devices are essential to support the healthcare industry. To ensure compliance, the Government has released a draft with new rules

What is new?

The Draft introduces two new rules, 18 A and 18 B, after Rule 18 in the Medical Device Rules of 31st January, 2017. The Rule may be called the Medical Devices Amendment, 2024.

The 18A rules include:

Qualification of the Medical Device Inspector: 

The inspection of the medical device manufacturing, sale, and distribution was conducted by officers who held a qualification in Pharmacy background and are equivalent to the drug inspector, but now they have introduced new qualifications, such as 

• Bachelor’s Degree in Engineering or Technology in Biomedical, Chemical, Mechanical, Electrical, Biotechnology, Polymer, Computer Science, or Medical Electronics Engineering, etc, from a recognised University or Institute.

Or

• Bachelor’s Degree in Pharmacy, Pharmaceutical Science, Microbiology, Biochemistry, or Life Science, etc, from a recognised University or Institute.

The 18 B rules include: 

The Qualification of Government Analyst:

• Bachelor’s of Engineering Technology in Biomedical, Chemical, Mechanical, Electrical, Electronics, Biotechnology, or Medical Electronics Engineering, etc.

                                                                 Or

• Bachelor’s in Pharmacy, Pharmaceutical Science, Microbiology, Biotechnology, or Life Science, etc, from a recognised University or Institute.

The newly proposed draft rules were issued under sections 12 (1) and 33(1) of the Drugs and Cosmetics Act of 1940, which were prepared after consulting with the Drugs Technical Advisory Board (DTAB). The MoHFW Government has invited applications for 30 days for the public to comment or provide suggestions, after the publication of the notification in the Official Gazette. The Stakeholders may submit their feedback to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Room no. 545, A Wing, Nirman Bhavan, New Delhi – 110011, or email to [email protected]. 

The release of the new amendment by the MoHFW marks a historic change in the Medical Device rules in India. It sets clear technical and scientific qualifications for the inspection and analysis of Medical devices. Through this, the government is ensuring that the testing of the devices is handled by experts who have knowledge of the technology. This move not only enhances the safety of patients and the quality of the devices but also opens exciting Life Science opportunities for various Science Graduates.