Changes in the design of medical devices can have significant implications on their quality, performance, and regulatory compliance. Any alterations that affect the specifications, indication for use, performance, or stability of a medical device are considered major changes. In India, such changes require prior approval from the Central Drugs Standard Control Organization (CDSCO) before implementation. […]
At #8C, we wanted to start a new initiative of creating a š¬šš«š¢šš¬ šØš š ššš¬, dealing with medical devices and its regulations. In that effort, here is the ššššš ššØšø. Hope you like these #titbits of information. Here is #FAQ01 on holding š¦š®š„šš¢š©š„š š¢š¦š©šØš«š š„š¢ššš§š¬šš¬
The Gazette Notification, released on 18th Jan 2022, gave a provision for #Registration_Listings, for newly regulated Medical Devices
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