Broad Range of Medical Devices to Be Subject to New Risk Assessments Under India Proposal

Moving to better codify regulations on its growing medical device industry and market, the Indian government in September proposed making 24 categories of medical devices subject to risk-based assessments. The effort by India’s Central Drugs Standard Control Organization (CDSCO) is designed to clarify requirements and regulations on the medical devices, and to ensure the safety, quality, and performance of devices sold in the country.

Since 2017, when India passed a law establishing regulations on the medical device industry, authorities have sought to put in place a robust regulatory mechanism for devices. Previously, the medical device industry in India was largely unregulated, with only a small number of product families requiring registration by the government. These few device product families were treated as pharmaceuticals under the regulations.

The categories of medical devices subject to the new regulations cover a wide range of products, from obstetric and gynecologic devices to respiratory systems to software. Even feminine sanitary products and infant bassinets would be subject to the proposed regulations.