CDSCO, THE REGULATORY AUTHORITY
The Central Drug Standard Control Organisation (CDSCO) is the pivotal regulatory body for medical devices, including ventilators. The regulation is carried out either through the listing or registration of devices.
MEDICAL DEVICE RULES 2017, THE GUIDING REGULATORY FRAMEWORK
With the introduction of The Medical Device Rules 2017, which came into effect in January 2018, the stage has been paved for simplifying and streamlining the regulatory framework set out rules and norms for obtaining registration and licenses by manufacturers and importers of medical devices. And this would also apply to ventilator manufacturers. Very importantly, the intent was to treat medical devices as distinguished from drugs for regulation for the first time since the Drugs and Cosmetics Act, 1940 came about.[1] Yet, as of today, practically speaking, medical devices, including ventilators, continue to be treated as drugs for regulatory purposes.
A RISK-BASED CLASSIFICATION SYSTEM
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OUR STRATEGY IN EMERGING MARKETS FOCUSES ON INNOVATION AND AFFORDABILITY
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