New Medical Device Rules To Be Rolled Out In 2018

The Drugs and Cosmetics Act, 1940, has been governing drugs and medical devices since 1940 and has received multiple iterations each year. Owing to the significant changes that have occurred in the healthcare and pharmaceutical industry and constant requests from leaders in these industries, an overhaul was long overdue. In that vein, a draft of Medical Devices Rules, 2016 was published in October 2016 [1]. Now, the Medical Devices Rules will be published later this year as announced by the Finance Minister Hon. Mr. Arun Jaitley. These will be as per the gazette outlined by Ministry of Health & Family Welfare in consultation with the Central Drugs Standard Control Organization (CDSCO) and Drugs Technical Advisory Board (DTAB). With intent to set Indian guidelines at par with international standards, these new laws have been made as per the framework of Global Harmonisation Task Force (GHTF) [1].

As per new guidelines, the categorization for in vitro, as well as other devices, will be as follows –

1. Low risk -class A
2. Low-moderate risk- class B
3. Moderate-high risk- class C
4. High risk- class D

Here is a detailed list of medical devices that are used in India. They can be classified into “Surgical” and “Non-surgical devices”, based on the invasiveness of the devices:

1. Surgical Devices – 
   • Aesthetics (Breast Implants, Tissue grafts, Dermal Filler, Implants, Injections);
   • Cardiology (Annuloplasty System, Heart Valves, Balloon Catheters, Bio-prosthetics, Cannula, Cardioverter Defibrillator, Catheters, Access Port System, Cannula, Guidewires, Sheaths, Shunt, Occlusion and Aspiration System, Plaque Excision System, drug eluting Stents, Filter System, Pacemaker, Temporary Pacing Electrodes, Radiofrequency Ablation (RFA) );
   • Contraceptives (Copper T);
   • Dental (Denture cream, dental cement, Implants, Abutments, Scaffolds);
   • ENT (Hearing Prosthesis, Implants, Ossicular Prosthesis);
   • Gastroenterology (Endotracheal Tubes, Open Suction Catheters, and Kits, Nasogastric Tubes (NG Tubes), Hernia System, Ligation Device, Stents, Intra-Abdominal Pressure System);
   • Gynecology (Catheters, Grafting System, Tubal Rings, Pelvic Floor Repair System, Stents);
   • IVD (Blood Testing, Cell Processing, Filter Sets, Lab Kit, Prep Pads, Stem Cells);
   • Neurology (Catheters, Distraction System, Fixation System, Grafting System, Implants, Reconstruction Device, Stents, Guidewires, Catheters);
   • Oncology (SIR-Spheres);
   • Ophthalmology (Bandages, Catheters, Eye Drops, Implants, Intraocular Gases, Lens, Occluder);
   • Orthopedic (Bone Cements, Bone Substitutes, Cervical Plates, Bone Void Filler, Plates, Screws, Cables, Casting Tapes, Coils, Discs, Metal Acetabular Augments, Metal Revision Shells, Femoral Cone, Mesh, Metal Tibial Cone, Fixation System, Grafting System, Haemostatic Powder, Hip implants, Knee implants, Elbow implants, Joint implants, shoulder, Nail system, Tibial Augments, Metallic Anchors);
   • Pulmonary (Catheters, Suction System, Tubes, Valve system);
   • Spine (Bone Cement, Bone Void Filler, Cages, Cervical Plates, Discs, Fusion Device, Spacer, Fixation System, Implants, Screws);
   • Surgical equipment (Catheters, Disposables, Endoscopic Applicator, Tips, biopsy devices);
   • Syringes and Needles (Blood Transfusion Set, Cannula, Catheters, Infusion Wires, IV Flow Regulators, Disposable Hypodermic Syringe, Disposable Hypodermic Needle, Disposable Hypodermic Perfusion Sets, Stopcocks, Syringes);
   • Urology (devices for Urinary Incontinence, Urine Collection; Catheters, Stents, Dialysis, Filters, Guide Wires, Stents, Foley Catheters, Temperature-Sensing Catheters, Foley Stabilization, Foley Trays and Kits, Intermittent Catheters & Trays, Specialty Foley Catheters, Brachytherapy);
   • Vascular (I.V. Cannula, Catheters, closure Device, Elite snare, Embolization Device, Filters, Grafting System, Guide Wires, Occluder, Prosthesis, Reconstruction Device, Sheaths);
   • Wound Care and Surgical Dressing material (Bandages, Casting Tapes, Catheters, closure Device, Collagen Membrane, Dressings, Closure Device, Fasteners, Hemostatic Foam, Hemostatic Pads, Mesh, Splint Rolls, Staplers, Surgical Drapes, Surgical Sealant, Sutures and ligatures, umbilical tapes)
   • Computer Assisted Surgery (Cables and Accessories)
2. Non-Surgical Devices – 
   • Blood Storage (Blood Bag System, Bloodlines, Filters, Platelet Storage);
   • Contraceptives (Condoms);
   • Gynecology (Tampons);
   • In vitro Diagnostic Devices (HIV, HBsAg, & HCV)

Redefinition of Roles of Regulatory Authorities:

1. The Central Govt., will be directly involved in the regulation of Class C & D devices. It will oversee the import of all medical devices across the four classes (A, B, C, & D). It will also be responsible for evaluating the clinical efficacy and approval of all new in vitro diagnostic devices. It will oversee the clinical investigations and approvals for medical devices used for investigative purposes.
2. The State Govt., will be directly supervising the manufacture of Class A & B devices. It will oversee sale and distribution of devices of all the 4 classes.

New Guidelines for Manufacturing License of Medical Devices:

1. For an application for a license to manufacture for distribution/sale of Class A & B devices, the application should be made online in Form MD- 3 or Form MD- 4 (for loan license) along with a fee. The license will be obtained under Form MD-5 or Form MD- 6 (for loan license).
2. For an application for manufacture for distribution/sale of Class C & D devices, the application should be made online in Form MD- 7 or Form MD-8 (for loan license) along with a fee. The license will be obtained under Form MD-9 or Form MD- 10 (for loan license).

New Guidelines for Import of Medical Devices:

1. An application should be made online to the Central Licensing Authority (CLA) under Form MD- 14 for obtaining a license to import for sale or distribution via an authorized agent already possessing a license for manufacture for sale/distribution of medical devices or a wholesale license for sale/distribution of medical devices.
2. If the registration is compliant, the license will be issued under Form MD-15.