All Medical Devices To Be Treated As ‘Drugs’ From April 1

The central government, on Tuesday, released a notice according to which all medical devices sold in the country would be treated as drugs and would be regulated under the Drugs and Cosmetics Act of 1940.

The new rule will affect the low value, low risk, high-volume medical device category as local micro and all the small scale device manufacturers will have to register themselves on a centralized online portal for quality control and assurance. As of now, only 23 medical devices are being categorized as drugs and only a few of these, including cardiac stents and intrauterine devices, have been brought under price control.

Now from April 1, all devices from disposable syringes, catheters, intraocular lenses and nebulizers to condoms, tubal rings, umbilical tapes, and even blood pressure-monitoring devices will be counted under the Drugs section.

The notice also released some standard categories under which the medical devices should be placed. These are- low risk, moderate low risk, moderate-high risk, and high risk. “We urgently need comprehensive reforms to strengthen the regulatory mechanism in relation to patients’ safety,” said Malini Aisola of All India Drug Action Network.