The Drugs Controller General of India (DCGI) is planning to amend the Medical Devices Rules, 2017 to include a provision for quality requirement for non-sterile and non-invasive medical devices such as thermometers, stethoscopes, elastic bandages, and non-electrical wheelchairs.
Currently, there is a provision for licence exemption to manufacture and import Class A medical devices (non-sterile products) for marketing in the country and conformance to quality management system for manufacturing of such medical devices is not included in the existing rules.
The matter was discussed in a meeting of the Drugs Technical Advisory Board (DTAB), the country’s top technical advisory body on drugs and medical devices, held last month
