Overview of India’s Medical Device Regulatory Framework

As the Indian medical device market undergoes rapid growth, the country’s regulators introduced the National Medical Device Policy, 2023 to support public access to quality medical products, boost domestic manufacturing capacity and foster innovation in device development.

The National Medical Device Policy complements existing Indian legislation and regulation including the Drugs and Cosmetics (D&C) Act, 1940 and the Medical Device Rules, 2017. 

Core focus areas of Indian medical device regulations

In this white paper, Emergo by UL provides an overview of key regulatory requirements in the Indian National Medical Device Policy, including:

• Regulatory streamlining and harmonization with global standards
• Infrastructure development and support for common testing and laboratory facilities
• Research and innovation to support India’s domestic medical device manufacturers and incorporate global best practices
• Human resource development to enhance training and promote higher education in medical device technology
• Brand positioning and awareness to drive public awareness of medical device safety and standards

White paper authors also explain the role of the Central Drugs Standard Control Organization (CDSCO) in Indian medical device market oversight.