India overhauls medical device safety rules, expands digital surveillance

Dr Aashish Chaudhry, managing director at Delhi-based super-speciality hospital Aakash Healthcare, said, “As doctors, we have seen instances where certain implants or medical devices have not delivered adequately, while concerns have not always received timely attention. The new surveillance framework can strengthen reporting, accountability and corrective action. It is equally important for doctors and healthcare institutions to become more compliant and proactive in reporting adverse events and device failures. If an innovation does not benefit patients or compromises safety, it must be investigated, addressed and, where necessary, recalled promptly.”