The government on Tuesday issued a final notification to consider all medical devices as drugs, bringing them under the purview of the drugs regulator and tightening regulations for them to improve safety and quality.
According to the notification by the ministry of health and family welfare, all medical devices, including implants and contraceptives, will be brought under the lens of the Central Drugs and Standard Control Organization (CDSCO) in a phased manner starting 1 April.
The notification will also re-categorize medical devices that are used for life support, diagnosis, treatment or alleviation of any disease or disability, and even devices that are used to disinfect other medical devices. These effectively cover all medical devices that are sold in the market.
Under medical devices rules, low risk-devices are inspected by private notified bodies while licenses were given by CDSCO. For high-risk devices, inspection and licensing are both done by CDSCO.
“That structure will remain, but this notification will make enforcement of norms for medical devices more stringent and bring them on a par with drugs," a senior government official said, adding that the health ministry will come out with another notification later to provide a transition period for various categories of medical devices.
Currently, medical devices are classified under four categories. Class A and B medical devices are low-risk ones like surgical dressing, alcohol swabs, thermometers, blood pressure monitoring devices among others. Class C and D are high-risk devices like implants, hemodialysis catheters, angiographic guide wire and heart valve.
The increased scrutiny on medical devices comes in the aftermath of Johnson & Johnson’s faulty hip implants.
The reclassification follows a recommendation by Drugs Technical Advisory Board (DTAB), the government’s top advisory body on drugs, in its meeting in April last year.