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Global Affairs: India


Currently, 14 categories of medical devices are regulated as “Drugs” under the Drugs and Cosmetics Act of 1940. While the current system allows for the entry of medical products onto India’s health market, the lack of transparency and unpredictability associated with this “mis-matched” regulatory system causes backlogs and delays the entry of lifesaving technologies. As India strives to promote access to healthcare – and in doing so build up their own domestic healthcare industry - the government has come to recognize that medical technologies and the regulatory infrastructure to support their development are a critical element in the healthcare delivery system and infrastructure. The medical device industry is committed to working with the Indian government to develop an appropriate regulatory framework for medical devices.

AdvaMed's Efforts

Regulatory: Develop an appropriate regulatory system that provides a high level of patient safety while fostering innovation and investment.

Payment: Advance fair and appropriate pricing and reimbursement policies that recognize India's public health challenges and the value of medical technology in addressing them

Public Affairs: Contribute towards building India’s healthcare capacity and foster constructive dialogue with Key Opinion Leaders.