The Union Health Ministry has proposed amendments to India’s Medical Devices Rules (MDR), 2017, aiming to strengthen regulatory oversight in the country’s MedTech sector. The draft Medical Devices (Amendment) Rules, 2024 introduce clear educational qualifications for medical device inspectors and government analysts through two new provisions — Rule 18A and Rule 18B.
Key Provisions under the MDR 2017 Amendment
Under Rule 18A, candidates eligible for appointment as medical device inspectors must hold:
A bachelor’s degree in engineering or technology in biomedical, mechanical, electrical, electronics, instrumentation, chemical, polymer, biotechnology, or computer science; or
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A graduate degree in science or pharmacy specializing in chemistry, pharmaceutical sciences, microbiology, or biochemistry.
Similarly, Rule 18B outlines comparable qualifications for government analysts responsible for testing and evaluating medical devices in central and state laboratories.
Strengthening Regulatory Competence in India’s MedTech Sector
The proposed amendment aims to ensure that inspections, market surveillance, and manufacturing assessments are carried out by technically qualified professionals with relevant industry expertise.
This represents a major shift from the earlier system, where officers from general drug regulatory backgrounds managed medical device licensing without specialized technical training.
By defining minimum educational qualifications, the Health Ministry seeks to enhance scientific competence within the Central Drugs Standard Control Organisation (CDSCO) and state licensing authorities, aligning India’s regulatory framework with international best practices such as those followed by the US FDA and EU notified bodies.
Public Consultation and Next Steps
The draft notification, released for stakeholder comments in October 2025, will remain open for 30 days. After reviewing the feedback, the Ministry will finalize the amendment and publish it through a Gazette notification.
Once implemented, the revised MDR 2017 will mark an important step toward building a more qualified and technically sound regulatory workforce for India’s growing medical device industry.
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