The Indian Medical Devices Landscape and Class B Regulation For Blood Management Devices

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The Indian Medical Devices Landscape and Class B Regulation For Blood Management Devices

The government has been taking strategic steps to boost the growth of the medical device market in India, providing the regulatory framework to help the country achieve better healthcare standards, in line with global guidelines. The Central Drugs Standard Control Organization (CDSCO) is the primary regulatory body responsible for the approval and regulation of pharmaceuticals, medical devices, and blood management products in India. Recently, a landmark step has been taken in terms of the regulatory position for effective blood management. The CDSCO made it mandatory for all blood and blood-related components to be stored and transported in medical-grade equipment with class B certification to ensure the quality and safety of these biologicals. This discourages the use of inferior-quality cold chain equipment in this space and creates more awareness regarding the use of proper medical-grade cold chain solutions.

This paper takes a closer look into the Indian Medical Devices landscape and how the recent Class B Regulation for Blood Management Devices affects the various stakeholders in the market.

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