FDA 510(k) and CDSCO approval differ in classification, review timelines, fees, and import requirements. Understand these seven key differences before planning to sell a medical device in the US and India. A medical device prototype is sitting on the table. It works. The mechanism has been tested, the enclosure has gone through multiple iterations, clinicians have seen it, and the founders are finally beginning to talk about manufacturing. Then someone asks: What do we need t