Medical devices to come under drugs regulators |
India on Tuesday issued a 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 India`s 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 in a phased manner starting 1 April. It also re-categorizes 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. 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.
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