Indian regulators publish new classification lists for medical device registrants

India’s Central Drugs Standard Control Organization (CDSCO), which regulates the country’s medical device market, has published new risk-based classification lists covering several major device types for use by Indian market applicants.

The latest CDSCO classification lists cover six broad categories of devices:

• Nephrology and renal care (44 devices included)
• Operation theatre (26 devices)
• Pain management (26 devices)
• Personal protective equipment (PPE) (32 devices)
• Software (60 devices)
• General hospital (57 devices)

Although these lists have been finalized by CDSCO following consultations with stakeholders, Emergo by UL consultants note that the regulator has yet to add them to the SUGAM online device registration portal. Until their official including in the SUGAM portal, Indian medical device market registrants should use these lists only as references for finalizing risk classes of their products.

The CDSCO began issuing new risk-based medical device and in vitro diagnostic (IVD) classification lists in late 2020 in order to clarify regulatory pathways and compliance requirements for manufacturers and sponsors under India’s Medical Device Rules, 2017.

Learn more about medical device and IVD regulations in India:

• India CDSCO medical device registration and approval consulting
• India medical device regulatory strategy report
• Whitepaper: The new Indian Medical Device Rules, 2017