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Classification of medical devices under the new rule of “Medical Devices Rules 2017” are classified as: Low Risk – Class A – (Surgical Retractors, Tongue Depressors)Low Moderate Risk – Class B – (Hypodermic Needles, Suction equipment)Moderate High Risk ­– Class C – ( Lung Ventilator, Bone Fixation Plate)High Risk – Class D – (Heart Valves, Implantable Defibr","@type":"Answer"}},{"name":"Does primary packaging material require license from Indian FDA?","@type":"Question","acceptedAnswer":{"text":"In India, manufacturers of primary packaging materials generally do not require a CDSCO manufacturing license unless the material itself is classified as a medical device or accessory under the Medical Devices Rules, 2017; however, they must comply with applicable quality and safety requirements expected by medical device or pharmaceutical manufacturers. 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