CDSCO releases Risk classification of Medical Devices and IVDs

Through a recent notification, Drugs Controller General (India), Directorate General of Health Services, India's central medical device regulator, the Central Drugs Standards Control Organization (CDSCO), has issued a revised risk classification of medical devices and IVDs on the basis of their intended use under the provisions of the Medical Devices Rules, 2017.

At present, the Central Regulator has classified 328 medical devices into various risk classes. A convenient (but not perfect) way to check whether a company's medical device has been classified or not is as follows. If the device is regulated as on date, i.e. if an import registration/license or manufacturing license for the license has been obtained, then the device in all likely hood has been classified.

Medical devices other than in vitro diagnostic medical devices will be classified on the basis of parameters specified in part I of the first schedule, namely low risk as Class A; low to moderate risk as Class B; moderate to high risk as Class C; and high risk as Class D.

In vitro diagnostic medical devices will be classified on the basis of parameters specified in part II of the First Schedule, namely low risk as Class A; low to moderate risk as Class B; moderate to high risk as Class C; and high risk as Class D.

As per the classification issued by the DCGI, Class A includes perfusion sets, Surgical Dressings, Umbilical occlusion device, Bolster Suture, Alcohol Swabs.

Class B includes Fiber-optic Oximeter Catheter, A-V Shunt or Fistula Adapter, Forceps endoscopic, Vessel Dilator for percutaneous Catheterization, Tracheobronchial Suction Catheter, Cervical Drain, Rectal Balloon, Vial Adapter, Nasopharyngeal Catheter, Esophageal obturator, Suction Tip and Catheter, Arterial Catheter, Cholangiography Catheter, Umbilical Artery Catheter, Flow Directed Catheter, Endoscopic Ligation Devices, Dialysate Tubing and Connector, Colon Tube, Connecting Tube, Decompression Tube, Biopsy Needle Kit, Mammary Biopsy Needle, Cholangiography Needle, Epidural Needle

Class C includes Anastomosis Bypass Tube, Micro-catheter, Coronary Dilation Catheter, Vein Ablation device, Thermal Ablation device, Uterine balloon therapy devices, RF Conducted MR steerable electrode catheter, Bone cement, Bifurcation Stent, Vena Cava Filter Sets, Central Venous Catheters, Introducer Sheath, Carotid Filter System, Hemodialysis Catheter (Long Term), Percutaneous Intravascular Long Term Catheter, Implanted Subcutaneous Intravascular Port & Catheter, Subcutaneous Intraspinal Port & Catheter, Diagnostic Radiology Catheters, Tympanostomy Tube.

Class D includes Radiofrequency Ablation Device, Percutaneous Conduction Tissue Ablation, Coronary stent, Bioresorbable Vascular Scaffold (BVS) System, Angiographic Guide Wire, Cardiac Catheterization Kit, Balloon for Cerebrovascular Occlusion, Intra-Aortic System Balloon and Control, RETRIEVAL SNARE, Cardiac Thermodilution Catheter, Cardiovascular Catheter, Cerebrospinal Catheter, Atherectomy coronary Catheter.

Here is the attached pdf of full notification issued by the CDSCO