Moving to bring regulatory order to its growing medical device industry and market, the Indian government has begun drafting quality and efficacy standards that would cover all medical devices sold in the country. The effort by India’s Central Drugs Standard Control Organization (CDSCO) would for the first time impose regulations on all medical devices. Currently, only 23 categories of medical devices are subject to regulation in the country.
Since 2017, when India passed a law establishing regulations on the medical device industry, authorities have sought to put a robust regulatory mechanism in place. 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 product families were treated as pharmaceuticals under the regulations.