New Delhi: In a move to align India’s regulatory framework for medical device software with global standards, the Central Drugs Standard Control Organization (CDSCO) has released new draft guidelines for grant of licence to manufacture or import for sale, distribution of devices in the country.

Issuing a public notice, the Drugs Controller General of India (DCGI) announced that, “...to align the requirements of Medical Device Software with globally harmonized practices, a draft of the Guidance Document on Medical Device Software is prepared to bring more clarity on the regulatory aspects.”

This guidance documents provides scope, definition, Classification, standards, requirements of technical documents and Quality Management system applicable for Medical Device Software, the notice add

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