India’s Central Drugs Standard Control Organization (CDSCO) publication Medical Device Rules 2017 made sweeping changes in regulation of medical devices to improve quality healthcare and raise manufacturing and safety standards. The framework has been effective since 2018 and has improved standards in registration, regulation and safety. These changes complement the Drugs & Cosmetics Act, which only regulates 23 medical devices as drugs. CDSCO rules are more comprehensive in bringing medical devices into specific regulation and safety standards.
Many medical devices and equipment have not been regulated by Indian authorities. Standards in India had been relying on foreign quality standards and according to the Times of India, over 80% of medical devices are imported. The 2017 rules will now require foreign manufacturers to register devices with an Authorized Agent, who in turn would be mandated to have license to sell and distribute medical devices. Regulators will have the option of requiring on-site audits of overseas manufacturing facilities. Most likely waivers will be made for American, European Union, Canadian, Japanese and Australian imports.
There are new classifications for devices, rules for foreign manufacturers and audits, a new fee structure, and licensing standards. Starting in 2022 Unique Device Identification (UDI)s will be required of all medical devices and IVDs. Test licenses will be valid for three years instead of one year. CDSCO will now assign classification to devices, rather than manufacturers, further tightening standards. Most notably, these changes will mirror ISO 13485:2003, elevating India’s standards in the global market.
India is currently the fourth largest medical device market in India worth $7 billion. Accordingly, the market potential is $50 billion by 2025. These improvements in standards position India’s market potential while providing significant healthcare standards across the board. As debate ensues regarding tariffs in the Asian, European and American markets, could India be healthcare manufacturers’ best next thing?