India Revamps Medical Device Regulations

January 10, 2025

The Government of India is revising its regulatory framework for medical devices to enhance safety and efficiency. This initiative aims to classify approximately 1,178 medical devices into four distinct categories based on their risk profiles. The Central Drugs Standards Control Organization (CDSCO) is spearheading this effort under the Medical Device Rule, 2017. The new classifications will ensure that medical devices are approved only by the appropriate State Licensing Authorities, thereby improving oversight in the sector.

Classification Categories

The medical devices will be divided into four categories

Interventional radiology – 186 devices
Radiology therapy – 114 devices
Oncology – 75 devices
A new class A for non-sterile and non-measuring devices – 803 types of medical equipment.

Market Growth Projections

India’s medical devices market is currently valued at approximately $11 billion. Experts predict that this market will expand to $50 billion by 2030. This growth is attributed to increased healthcare demands and advancements in medical technology. The regulatory updates are expected to facilitate this growth by ensuring that devices meet safety and efficacy standards.

Current Regulatory Framework

All medical devices in India are governed by the Medical Device Rule, 2017. Under this framework, the Central Licensing Authority is responsible for classifying medical devices based on a risk-based approach. This ensures that higher-risk devices undergo more stringent scrutiny before approval.

Industry Feedback and Updates

The CDSCO has reached out to industry stakeholders for feedback on the updated classification list. Rajeev Singh Raghuvanshi, the Drugs Controller General of India, indicated that the list would be finalised soon. Stakeholders are encouraged to propose additional devices for classification to ensure comprehensive coverage.

Categories for Registration

There are currently 24 categories designated for the registration of medical devices. These categories include anesthesiology, pain management, cardiovascular, dental, gastroenterological, respiratory, and neurological devices. The classification aims to provide clarity and harmonisation in the approval process of medical devices across India.

CDSCO – Central Drugs Standards Control Organization.
MDR – Medical Device Rule, 2017.
DCGI – Drugs Controller General of India.
Class A devices – Non-sterile and non-measuring medical devices.
86% – Proportion of medical devices in India that are imported.

Challenges in Domestic Production

The medical device industry in India faces several challenges, including high capital intensity and long development cycles. Although there have been efforts to boost domestic production, most devices imported are high-value and low-volume. Conversely, local production tends to focus on low-value, high-volume diagnostic tools.

Government Initiatives for Industry Support

In November 2023, the government launched a scheme to strengthen the medical device industry, with an initial budget of ₹500 crore. This initiative spans three years, from 2024 to 2027, and targets critical areas such as manufacturing key components, skill development, clinical studies, and promoting the industry. The regulatory reforms and government initiatives aim to enhance the safety, efficacy, and growth potential of India’s medical device sector, ultimately benefiting the healthcare landscape across the country.

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