An Overview of Classification of Medical Devices by CDSCO

The rules regarding different classes of medical devices were published by the Central Government in 2017. The term ‘Class’ is very important in these rules because different rules and procedures are prescribed for different classes of medical devices but it was not explained clearly which device falls into a particular class. This ambiguity makes it difficult to properly implement these rules. To solve this problem, the Medical Device Division of Central Drugs Standard Control Organization of India (CDSCO) issued a notice in 2020 and properly classified the medical devices into different categories and four classes which are A, B, C, and D. In this article we are going to discuss the same and explain every technicality involved to make it easier for you to understand.

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What is Medical Device?

Before categorizing them into classes, we should understand what medical device actually is that we are referring to again and again. It is defined under the Medical Devices Rules of 2017. The definition includes in vitro diagnostic devices, surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood collection bags, blood component collection bags mechanical contraceptives, intrauterine devices, disinfectants, insecticides and other devices as notified by the central government from time to time. IVDs stand for In-vitro diagnostics, which are tests used to detect diseases, conditions, and infections. In-vitro means 'in glass', which means that the tests are usually done in test tubes and similar equipment.

Classification of Medical Devices

For their registration, certification and licensing purposes, medical devices are divided into four groups based on their level of risk. These groups are named Class A, B, C, and D. Class A devices are considered to have the lowest risk while Class D devices have the highest risk. To determine which class a medical device belongs to, there are specific rules called the Medical Devices Rules, 2017, which include a list of parameters. These parameters vary depending on the type of device (in-vitro or other medical devices) and take into account the device's intended use. If two separate devices are used together, they are both classified under the same risk class.

Use of Classification of Medical Devices

These classes are used in the application form to get a manufacturing licence for medical devices in India. Different forms are used to apply for medical devices of different classes. The process can be completed online through the CDSCO portal. A certificate is provided for the license of manufacturing these medical devices for separate classes after the successful completion of the process.

Read Our Blog: Procedure for Manufacturing of Class C and Class D Medical Devices in India

List of Medical Device Categories and Classes

Taking into account the above-mentioned criteria given in the Medical Devices Rules of 2017, CDSCO created a list of more than eighteen hundred medical devices and distributed them into 24 categories. Then on a risk-based approach, these devices are assigned a class out of the four defined classes. These categories are as follows-

Anesthesiology

Anesthesiology is a medical branch that specialises in administering anaesthesia to patients undergoing medical procedures, ensuring their comfort and safety during the process. In this category, 115 medical devices are listed. Some examples of the medical devices included in this category are as follows-

• Class A - Aerosol Delivery Tubing, Airway Protection Face Mask, Anesthesia Warmer etc.
• Class B - Anaesthesia Depth Monitor, Aerosol Inhalation Monitor, Aerosol Face Mask etc.
• Class C - Anaesthesia Vaporizer, Anesthesia Machine etc.
• Class D - Spinal Needle Bioimpedance Navigation Unit etc.

Pain Management

In this category, those devices are included that give relief to pain. They can mechanically assist the patient or help him in his posture management which results in pain relief. In this category, 69 medical devices are listed. Some examples of the medical devices included in this category are as follows-

• Class A - Bite Relief Pad, Ear Microsystem Needle, Ice Collar etc.
• Class B - Cold-Air Therapy Unit, Arthritis Tens System, Acupuncture Kit etc.
• Class C - Cryogenic Analgesia Unit, Medium-Wave Diathermy Treatment System, Neurophysiologic Monitoring System etc.
• Class D - Implantable Intrathecal Infusion Pump, Implantable Lumbar Neuromuscular Electrical Stimulation System etc.

Cardiovascular

Cardiovascular medical devices are those devices that have involvement with the heart and the blood vessels. In this category, 37 medical devices are listed. Some examples of the medical devices included in this category are as follows-

• Class A - Pacemaker Test Magnet, Pacemaker Service Tools etc.
• Class B - Echocardiography, Vascular Clip, Vena Cava Clip etc.
• Class C - Pacing System Analyzer, Pacemaker Lead Adaptor etc.
• Class D - Ventricular Bypass (Assist) Device, Pacemaker Programmers etc.

Dental

Dental medical devices are the instruments used by dentists for the diagnosis, treatment, or prevention of oral health conditions. These devices include the instruments designed to use on teeth. In this category, 89 medical devices are listed. Some examples of the medical devices included in this category are as follows-

• Class A - Dental Excavator, Basic Manual Toothbrush, Dental Cotton Roll etc.
• Class B - Dental Suction System, Dental Suction System Pump, Performed Dental Crown etc.
• Class C - Trans mandibular Implant, Temporomandibular Joint Disc, Dental Amalgam Alloy etc.

Ear, Nose, Throat (ENT)

These are the devices that are used for the treatment of ears, nose and throat. These organs are interconnected and hence treated in the same category. In this category, 78 medical devices are listed. Some examples of the medical devices included in this category are as follows-

• Class A - Adenotome, Ear Bowl, Ent Trans illuminator etc.
• Class B - Audiometer, Impedance Audiometer, Ent Nasal Snare etc.
• Class C - Auditory Stimulator, Larynx Prosthesis, Suction Artichoke Device etc.
• Class D - Tympanic Membrane Contact Hearing Aid etc.

Gastroenterological

Gastroenterological medical devices refer to the devices used for the treatment of the digestive system, including the stomach, intestines, and associated organs. In this category, 163 medical devices are listed. Some examples of the medical devices included in this category are as follows-

• Class A - Enema Tip, Enteral Tube Extension, Gastrointestinal Ostomy Tube Pocket etc.
• Class B - Anal Fistula Circular Cutter, Endoscopic Overtube, Flexible Video Choledochoscope etc.
• Class C - Anal Fistula Seton, Bile Duct Prosthesis, Colonic Mucosa Barrier Dressing etc.

Urological

A urological device is a medical tool or instrument used in the diagnosis, treatment, or management of conditions related to the urinary system and male reproductive system. In this category, 90 medical devices are listed. Some examples of the medical devices included in this category are as follows-

• Class A - Bladder Neck Spreader, Female Wearable Urinal, Urinary-Incontinence Vaginal Insert etc.
• Class B - Cystometer, Incontinence Sensor, Lithotrite etc.
• Class C - Microwave Hyperthermia System Catheter, Prostatic Ablation, Laser Lithotripsy Suction Guide etc.

General Hospital

Items in this category are generally found in any hospital and are necessary for the overall management of the premises. In this category, 72 medical devices are listed. Some examples of the medical devices included in this category are as follows-

• Class A - Bed Exit Monitor, Fall Prevention, Patient Scale etc.
• Class B - Sterilization Process Indicator, Medical Bassinet, Intravascular Administration Set etc.
• Class C - Neonatal Incubator, Ingestible Event Marker, Steam Sterilizer etc.

Operation Theater (OT)

This category includes items that are generally found in an operation theatre and are used for surgical operations on the patient. In this category, 27 medical devices are listed. Some examples of the medical devices included in this category are as follows-

• Class A - Motorized Diagnostic Imaging View Box, Distractor, Retractors, Suction System Operated By Vacuum etc.
• Class B - Hemostatic Knife, Scalpel, Scalpel Blade etc.
• Class C - Surgical Robot Unit, Multiparameter Monitor With Critical Parameters, General-Purpose Electrosurgical Unit etc.

Respiratory

Respiratory devices are medical tools used to assist with the breathing process, either by supporting or replacing natural respiration. In this category, 71 medical devices are listed. Some examples of the medical devices included in this category are as follows-

• Class A - Breathing Circuit Bag, Dry Powder Inhaler, Airway Tube Forceps etc.
• Class B - Activated Oxygen Generator, Cerebral Oximeter, Cricothyrotome etc.
• Class C - Hyperbaric Chamber, Breathing Circuit Washer, Disinfector etc.
• Class D - Implantable Sleep Apnoea Treatment System etc.

Neurological

These devices are designated to interact with the nervous system which includes our brain, spinal cord and nerves. In this category, 131 medical devices are listed. Some examples of the medical devices included in this category are as follows-

• Class A - Cranial Bur, Electroencephalograph Tester, Manual Goniometer etc.
• Class B - Analgesic Pens System, Electromyograph, Gustometer etc.
• Class C - Depth Electrode, Echoencephalograph, Olfactometry System etc.
• Class D - Aneurysm Clip, Cortical Electrode, Implanted Cerebellar Stimulator etc.

Personnel Use

The devices included in this category are for personal use and are mostly available over the counter. They are the least harmful and contain a huge number of Class A devices. In this category, 24 medical devices are listed. Some examples of the medical devices included in this category are as follows-

• Class A - Face Shield, Particular Respirator, Radiation Protection Cap etc.
• Class B - Biosanitizer For Medical Devices, Nitrile Gloves, Medical Or Cadaver Body Bags etc.

Obstetrical and Gynecological (OG)

This category includes devices related to the female reproductive system, pregnancy, childbirth, the postpartum period, menstrual irregularities, fertility issues, and menopause. In this category, 116 medical devices are listed. Some examples of the medical devices included in this category are as follows-

• Class A - Birthing Bed Or Table, Gynaecological Operating Table Top, Heel Stirrup etc.
• Class B - Hysteroscopic Insufflator, Laparoscope System, Menstrual Cup etc.
• Class C - Breast Transilluminator, Foetal Bladder Shunt, Contraceptive Spermicide etc.
• Class D - Fallopian Tube Occlusion Insert etc.

Ophthalmic

The devices used in the diagnosis and treatment of eye-related issues are included in this category. In this category, 144 medical devices are listed. Some examples of the medical devices included in this category are as follows- 

• Class A - Amsler Grid, Binocular Vision Test Unit, Contact Lens Radius Gauge etc.
• Class B - Corneal Burr Manual Instrument, Euthyscope, Eye Heat Therapy Pack etc.
• Class C - Eye Valve, Intracorneal Ring, Ophthalmic Clip etc.
• Class D - Aqueous Or Vitreous Humour Replacement Medium Kit etc.

Rehabilitation

Rehabilitation devices are the devices that help people recover from injuries or disabilities and regain their physical abilities. They can be used in different places like hospitals, clinics, rehabilitation centres, or at home. In this category, 144 medical devices are listed. Some examples of the medical devices included in this category are as follows-

• Class A - Acupressure Calf Band,  Back Row Exerciser, Hydrotherapy Treadmill etc.
• Class B - Back/Leg/Chest Dynamometer, Physical Therapy Massager, Telemetric Diagnostic Spirometer etc.
• Class C - Pulsed Signal Therapy System, Foot Sensorimotor Therapy Mechanical Neurostimulator, Interferential Electrical Stimulation System etc.

Physical support

These devices are used to support people in their physical activities and posture management. In this category, 38 medical devices are listed. Some examples of the medical devices included in this category are as follows-

• Class A - Ankle Or Foot Orthosis, Cervical Spine Collar, Hand Or Finger Splint etc.
• Class B - Flotation Therapy Bed, Intermittent Traction System, Physical Therapy Massager etc.
• Class C - Neuro-Controlled Ambulation Exoskeleton etc.

Interventional Radiology

Interventional radiology devices are medical devices that are used to diagnose and treat a wide range of medical conditions. These devices are designed to be minimally invasive and to minimize the need for open surgery. In this category, 71 medical devices are listed. Some examples of the medical devices included in this category are as follows-

• Class A - Positron Camera, Nuclear Uptake Probe, Radiographic Film etc.
• Class B - Pneumoencephalo Graphic Chair, Nonfetal Ultrasonic Monitor, Medical Image Storage Device etc.
• Class C - Bone Densitometer, Fluorescent Scanner, Electrostatic X-Ray Imaging System etc.
• Class D - Transilluminator For Breast Evaluation etc.

Rheumatology

These devices are used to diagnose and treat the disorders that affect the musculoskeletal system, including bones, joints, muscles, and connective tissues. In this category, 11 medical devices are listed. Some examples of the medical devices included in this category are back braces, canes, shoe inserts, reachers, bottle and jar openers, stairway chair lifts and toilet frames etc.

Dermatology and Plastic Surgery

Dermatological devices are used to treat various skin conditions while plastic surgery devices are used to obtain cosmetic and reconstructive results. In this category, 56 medical devices are listed. Some examples of the medical devices included in this category are as follows-

• Class A - Eye Pad, Drape Adhesive, Dermatome, Occlusive Wound Dressing etc.
• Class B - Organ Bag, Suture Retention Device, Gas-Powered Dermatome etc.
• Class C - Polymer Ligating Clips, Carbon Dioxide Laser, General Electrosurgical Unit etc.

Pediatric and Neonatology

Pediatric and neonatology devices are specifically designed for infants, children, and adolescents and used to diagnose and treat various medical conditions of these young patients. In this category, 137 medical devices are listed. Some examples of the medical devices included in this category are as follows-

• Class A - Assistive Ergonomic Chair Mobility Base, Infant Limb Immobilizer, Infant Care Table etc.
• Class B - External Counterpulsation System, Aerosol Tent, Infant Heat Shield etc.
• Class C - Cuff-Suction Endotracheal Tube, Flexible Bone Nail, Infant Warmer etc.
• Class D - Craniofacial Bone Screw, Polyglyconate Suture etc.

Oncology

Oncologists use these devices for the purpose of staging, surgery, therapy and palliative care of cancer patients. In this category, 78 medical devices are listed. Some examples of the medical devices included in this category are as follows-

• Class A - Blepharoplasty Scissors, Capsular Tension Ring, Breast Binder etc.
• Class B - Cervical Cytology Scraper, Elastomeric Infusion Pump System, Flexible Video Bronchoscope etc.
• Class C - Activated Oxygen Generator, Brachytherapy Needle, Endocervical Aspirator etc.
• Class D - Breast Transilluminator, Flexible Ultrasound Bronchoscope, Extravascular-Circulation Hyperthermia System etc.

Radiotherapy

Radiotherapy devices are machines used to treat cancer. They work by delivering high-energy radiation beams to cancerous tumours to destroy or shrink them. In this category, 102 medical devices are listed. Some examples of the medical devices included in this category are as follows-

• Class B - Radiographic Protective Glove, Powered Radionuclide Brachytherapy Table, Laser Irradiation Therapy Kit etc.
• Class C - Conformal Brachytherapy Source, Breast Ductography Cannula, Brachytherapy Needle etc.
• Class D - Absorbable Tissue Spacer For Radiotherapy, Brain Manual Brachytherapy Applicator etc.

Nephrology and Renal Care

The devices used in the diagnosis and treatment of kidney-related issues are classified as nephrology and renal care devices. In this category, 39 medical devices are listed. Some examples of the medical devices included in this category are as follows-

• Class A - Crimp For Plier, Chair etc.
• Class B - Dialyser Connector, Rigid Nephroscope, Extracorporeal Circuit Waste Bag etc.
• Class C - Haemofilters, Kidney Stone Filter, Haemodialysis Concentrate etc.
• Class D - Absorbable Peritoneum Catheter Cuff, Collagen-Containing Peritoneum Absorbable Catheter Cuff etc.

Software

These are the software and programs designed to either assist a medical professional or to control a medical device. In this category, 60 medical devices are listed. Some examples of the medical devices included in this category are as follows-

• Class A - Continuous Glucose Monitor Retrospective Data Analysis Software.
• Class B - Software For Pulmonary Exercise Stress Monitoring System, Software For Vestibular Function Caloric Stimulator etc.
• Class C - Information Collating Software For Radiotherapy, Software For Radiation Planning, Diabetic Retinopathy Detection Device etc.

Conclusion

This is the comprehensive list of the devices classified into four classes and notified by CDSCO in furtherance of the Medical Devices Rules of 2017. There are some low-risk categories like software, dermatology and rehabilitation that do not have any Class D medical devices and also there are some high-risk categories like radiotherapy that do not have any Class A medical devices. This list will help manufacturing units and marketing companies decide under which class they need to get the license for a particular medical device.