From The Economic Times · Teena Thacker · · 1m
India's medical device rules to tighten safety enforcement
New rules could stop unsafe medical devices faster by letting regulators order destruction and halt sales
In brief
New rules could stop unsafe medical devices faster by letting regulators order destruction and halt sales Regulators can now directly stop unsafe medical devices from being made or sold without waiting for license cancellations Originally reported by The Economic Times.
Regulators gain new powers
India's government plans to let state and central authorities directly stop unsafe medical devices from being made or sold.
“Medical devices, ranging from implants and surgical instruments to diagnostic equipment and consumables, are routinely used in critical healthcare settings, where defective or substandard products can pose significant risks.”
Current rules lack enforcement
Existing rules only allow license suspension under the Drugs and Cosmetics Act, 1940 or Medical Devices Rules, 2017.
New rule targets unsafe products
The proposed change lets regulators order destruction of unsafe, defective, or substandard medical devices to prevent circulation.
Public health protection
Regulators can act faster to stop devices that could harm patients during critical medical procedures.
Clearer enforcement pathway
The change ensures proper documentation of destroyed devices to prevent unsafe products from re-entering circulation.
What it means
Regulators can now directly stop unsafe medical devices from being made or sold without waiting for license cancellations
