DCGI issues classification of medical devices & in vitro diagnostics under provisions of Medical Devices Rules, 2017
Even as the Medical Devices Rules, 2017 are to become effective in the country from January 1, 2018, the Drugs Controller General of India (DCGI) has issued classification of medical devices and in vitro diagnostic medical devices under the provisions of the Medical Devices Rules, 2017.
For the regulation of medical devices with respect to the import, manufacture, clinical investigation, sale and distribution, the Union health ministry, after consultation with the Drugs Technical Advisory Board, had notified Medical Devices Rules, 2017 vide G.S.R. 78 (E) dated 31.01.2017.
These Rules will be applicable to substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood and blood component collection bag with or without anticoagulant covered under sub-clause (i); substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides notified under sub-clause (ii); and devices notified from time to time under sub-clause (iv), of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940).
As per the Rules, 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.
Safety, quality and performance of medical devices are regulated under the provisions of the Drugs and Cosmetics Act, 1940 and rules made thereunder. In this connection, in exercise of the powers conferred under sub-rule (3) of rule 4 of Medical Devices Rules, 2017, the DCGI has classified the medical devices and in vitro diagnostic medical devices, based on the intended use of the device, risk associated with the device and other parameters specified in the First Schedule.
As per the classification issued by the DCGI, Radiofrequency Ablation Device, Percutaneous Conduction Tissue Ablation, Coronary stent, Bioresorbable Vascular Scaffold (BVS) System, Angiographic Guide Wire, Cardiac Catherization Kit, Balloon for Cerebrovascular Occlusion, Intra-Aortic System Balloon and Control, RETRIEVAL SNARE, Cardiac Thermodilution Catheter, Cardiovascular Catheter, Cerebrospinal Catheter, Atherectomy coronary Catheter, to name only a few, have been listed in the high risk Class D category.
Vein Ablation device, Thermal Ablation device, Uterine balloon therapy devices, RF Conducte MR steerable electrode catheter, Bone cement, Bifurcation Stent, Vena Cava Filter Sets, Central Venous Catheters, Introducer Sheath, Carotid Filter System, Hemodialysis Catheter (Long Term), Percuataneous Intravascular Long Term Catheter, Implanted Subcutaneous Intravascular Port & Catheter, Subcutaneous Intraspinal Port & Catheter, Coronary Dilation Catheter, Diagnostic Radiology Catheters, Micro-catheter, Tympanostomy Tube, Anastomosis Bypass Tube, etc have been listed in the moderate to high risk Class C category.
Fiberoptic Oximeter Catheter, A-V Shunt or Fistula Adapter, Forceps endoscopic, Vessel Dialator for percutaneous Catheterization, Tracheobronchial Suction Catheter, Cervical Drain, Rectal Balloon, Vial Adapter, Nasopharyngeal Catheter/Nasophar yngeal, Esophageal obturator, Suction Tip and Catheter, Arterial Catheter, Cholangiography Catheter, Umblical 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, etc have been included in the Class B category.
Nasopharyngeal Catheter/Nasophar yngeal, Y-Connector as an accessory to perfusion sets, Surgical Dressings, Umbilical occlusion device, Bolster Suture, Alcohol Swabs, etc have been included in the Class A category.