CDSCO issues draft guidelines to regulate medical device software

To align India’s regulatory framework for medical device software with globally harmonised practices, the Central Drugs Standard Control Organisation (CDSCO) has released a draft guidance document for grant of licence to manufacture or import device software for sale and distribution in the country.

- SANKET KOUL

The CDSCO has broadly classified medical software into two categories. The first includes software integrated into a physical medical device—known as Software in a Medical Device (SiMD)—such as insulin pumps.

The second encompasses software that operates independently for medical purposes — referred to as Software as a Medical Device (SaMD) — such as electrocardiogram (ECG) analysis tools.

These two kinds of software products support diagnostics, treatment, and patient monitoring. They are subject to strict regulatory standards to ensure safety, performance, and clinical effectiveness, the regulatory body noted.