01-May-18, Regulatory Affairs Professionals Society (RAPS)
India has adopted essential principles on the safety and performance of medical devices. The move establishes core standards that all medical devices sold in India must meet.
%20RAPS.jpg "India adopts essential principles on safety and performance of devices (c) RAPS")
Image: RAPS
The document establishes principles for all device manufacturers to follow and subsets of standards aimed at producers of specific types of product without making prescriptive recommendations.
India’s willingness to give manufacturers leeway to decide how to create devices that comply with its essential principles is evident in each of the seven standards that apply to all types of product. This includes following safety-focused principles.