Medtech industry expects regulatory body to reclassify more medical devices

Industry experts expect that the Central Drugs Standard Control Organisation (CDSCO) could reclassify more medical devices based on their risk approach under the Medical Device Rules (MDR), 2017.

This follows the apex regulatory body’s move to publish an updated list of classifications for 1,178 medical devices under four categories: interventional radiology, radiotherapy, oncology, and Class A (non-sterile and non-measuring) medical devices.