Health ministry releases draft list of devices & in vitro diagnostics along with risk-based classifications
After notifying the Medical Devices Rules 2017, which will come into force in the country from January 1, 2018, the Union health ministry has now issued the draft list of medical devices and in vitro diagnostics along with their risk-based classifications.
As per the Medical Devices Rules 2017, 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.
The devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central government by notification in official Gazette, after consultation with the Drugs Technical Advisory Board, fall under the definition of drug. The list of 15 devices notified so far in the country include disposable hypodermic syringes; disposable hypodermic needles; disposable perfusion sets; in vitro diagnostic devices for HIV, Hbsag and HCV; cardiac stents; drug eluting stents; catheters; intra ocular lenses; I.V. cannulae; bone cements; heart valves; scalp vein set; orthopedic implants; internal prosthetic replacements; and ablation device.
The new Medical Devices 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 draft list issued by the ministry, Radiofrequency Ablation Device, Percutaneous Conduction Tissue Ablation, Suction Ablation Catheter System, Fiberoptic Oximeter Catheter, Cardiac Catherization Kit, Balloon for Cerebrovascular Occlusion, Intra-Aortic System Balloon and Control, Keratoprosthesis, Detachable coils, Bone heterograft, Vena cava clip, Implantable Infusion pump, Glenoid fossa prosthesis, Vascular clip, Vascular embolization device, Intervertebral body fusion device, Haemo-Dialyzer System, Implantable cardiac pacemaker including accessories, Drug eluting stent, Vascular graft/occluders/Cardiac Patches and Implanted intracerebral/subcortical stimulator for pain relief, to name only a few, have been listed in the high risk Class D category.
A-V Shunt or Fistula Adapter, Enternal infusion Pump, Transcervical(Aminosco pe) Endoscope and accessories, Forceps, endoscopic, Anastomotic Microvascular Device, Angiographic Guide Wire and Accessories, Vessel Dialator for percutaneous Catheterization, Angioscope, Aspiration Needle and Syringe, Tracheobronchial Suction Catheter, Cervical Drain, Rectal Balloon, Biliary Stone Retrieval Basket, Contact Lens Bifola and Daily, Blood Administration kits, Biopsy Kit, Tracheostomy Tube/Tracheal Tube, Irrigating Syringes, Intravenous Cannula, Vial Adapter, Suprapubic, nondisposable Cannula and Trocar, Aortic Cannula, Arterial Cannula, Coronary Artery Cannula, Arthroscopy Drainage Cannula, Lacrimal, Hemodialysis Cannula, Cannula Injection, Uterine Insufflation Cannula, Continuous Positive Airway Pressure Nasal Oxygen Cannula, Salpngography Catheter, etc have beenl isted in the Class B category.
Likewise, Vein Ablation Device, Thermal Ablation Device, Injector Type actuator syringe, Transabdominal (Fetoscope) Aminoscope and Accessories, Anastomosis Device for Microvascular Surgery, Anastomosis Device for Gastroenterology Urology Use, Anaesthetic Conduction Kit, Ophthalmic Laser and Accessories, Embolic Particles System, Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis, Peritoneal Automatic Delivery System, Implanted Subcutaneous Intravascular Port & Catheter, Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis, Pacemaker lead adaptor, Surgical Dressings, etc have been listed in the moderate to high risk Class C category.
Bolster Suture, Cyclodialysis eye Cannula, Nasopharyngeal Catheter/Nasopharyngea l Class A, Umbilical occlusion device, Incontinence Urosheath Device, Pharynscope, etc have been included in the Class A category.