medical device classification in india

Classification of Medical Devices: Decoding CDSCO’s Medical Device Classification in India

Table of Contents

Unraveling the Medical Device Classification

Let’s dive into the intricacies of CDSCO medical device classification in India. The Central Government set the stage in 2017 with a set of rules outlining different classes for these devices. However, the clarity on which device fits where was as clear as mud. The term ‘Class’ became a crucial player in these rules, dictating different procedures for different classes, yet leaving us in the dark about the specifics.

The Ambiguity Issue

The lack of clarity in the initial rules made implementation a real head-scratcher. Imagine having the rules but not a clear guide on which devices fit into which class – a recipe for confusion. Recognizing this conundrum, the Medical Device Division of the Central Drugs Standard Control Organization (CDSCO) stepped in with a clarifying notice in 2020.

Clarification By CDSCO Medical Device Classification

In 2020, CDSCO took the bull by the horns and provided the clarity we all desperately needed. They meticulously classified medical devices into distinct categories and assigned them to four classes – A, B, C, and D. This move aimed to demystify the medical device classification process, ensuring that each device found its rightful place. In this article, we’ll break down the technicalities, making it a breeze for you to grasp.

Navigating the Medical Device Classes: A, B, C, and D

Let’s start with the basics – the four classes that serve as the backbone of CDSCO’s classification. Understanding the differences between Class A, B, C, and D is key to comprehending the regulatory landscape for medical devices.

Medical Device Classification for Class A – Low Risk, High Impact

Class A medical devices are the low-risk champions. They may not keep you on the edge of your seat, but they play a vital role in the medical landscape. CDSCO’s rules reserve a special set of procedures for these devices, recognizing their importance despite the low risk they pose.

Medical Device Classification for Class B – Stepping Up the Game

Moving up the ladder, Class B medical devices carry a bit more weight when it comes to risk. The rules surrounding them reflect this increased level of concern. As we delve into the specifics, you’ll see how CDSCO navigates the regulatory waters for these moderate-risk players.

Medical Device Classification for C – Walking the Tightrope

Class C medical devices are the daredevils of the medical world. With higher risk comes a more stringent set of rules. CDSCO takes a no-nonsense approach when it comes to ensuring the safety and efficacy of these devices. We’ll shine a spotlight on the intricacies involved in the classification of Class C medical devices.

Medical Device Classification for Class D – The High-Stakes Players

At the top of the hierarchy are Class D medical devices – the heavyweights carrying the highest risk. CDSCO’s rules for these high-stakes players leave no room for ambiguity. The scrutiny they undergo ensures that they meet the highest standards of safety and efficacy.

CDSCO’s Notice: A Game-Changer In Medical Device Classification

CDSCO’s notice in 2020 was a game-changer, bringing much-needed clarity to the classification of medical device. This notice serves as the guiding light for manufacturers, ensuring they understand the rules of the game and know exactly under which class their devices fall.

Medical Device Classification: How Risk Plays a Role

Now that we’re on the same page about what a medical device is, let’s talk about how they’re classified. It’s like putting them into risk-based gangs – Class A to Class D. Class A devices are the cool cats with the lowest risk, while Class D devices are the daredevils carrying the highest risk. The Medical Devices Rules of 2017 lay down the law, detailing parameters and criteria to determine which gang a device belongs to. CDSCO, armed with the Medical Devices Rules of 2017, crafted a list of over eighteen hundred medical devices spread across 24 categories. Let’s take a peek at some of the heavyweights in a few categories.

Anesthesiology: Keeping Things Numb and Safe

Anesthesiology, the art of numbing discomfort during medical procedures, boasts 115 devices spread across the classes. From Aerosol Delivery Tubing to Spinal Needle Bioimpedance Navigation Unit, it’s a list that ensures the patient is in cloud nine during medical interventions.

  • 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: Easing the Aches

With 69 devices dedicated to pain relief, this category is a hero for those battling discomfort. From Bite Relief Pads to Implantable Lumbar Neuromuscular Electrical Stimulation Systems, it’s a toolkit for comfort warriors.

  • 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: Matters of the Heart

For matters of the heart, quite literally, there are 37 devices categorized under Cardiovascular. From Pacemaker Test Magnets to Ventricular Bypass Devices, it’s a symphony for the circulatory system.

  • 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: Tools for the Perfect Smile

Dental devices, with 89 in their arsenal, ensure your pearly whites stay that way. Dental Excavators, Suction Systems, and Transmandibular Implants are just a few tools in this oral orchestra.

  • 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): Harmonizing the Senses

For the delicate trio of ear, nose, and throat, there are 78 devices. Adenotomes, Audiometers, and Tympanic Membrane Contact Hearing Aids ensure a sensory symphony.

  • 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: Tending to the Digestive Symphony

Digestive issues meet their match with 163 devices in Gastroenterology. Enema Tips, Anal Fistula Sets, and Colonic Mucosa Barrier Dressings – it’s a gastrointestinal gala.

  • 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: Taking Care Down There

Urology, with 90 devices, tackles issues below the belt. From Bladder Neck Spreaders to Laser Lithotripsy Suction Guides, it ensures smooth sailing for the urinary system.

  • 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: All-Round Essentials

The backbone of any hospital, with 72 devices in its arsenal. From Bed Exit Monitors to Neonatal Incubators, it’s the operational symphony every hospital needs.

  • 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): The Surgical Symphony

For the surgical maestros, 27 devices grace the Operation Theater. Motorized Diagnostic Imaging View Boxes, Hemostatic Knives, and Surgical Robot Units make this list a surgical symphony.

  • 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: Breathing Life into Medicine

With 71 devices, Respiratory devices are the breath of fresh air. Breathing Circuit Bags, Hyperbaric Chambers, and Implantable Sleep Apnea Treatment Systems compose this respiratory orchestra.

  • 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: Navigating the Nervous System

Interacting with the nervous system, these 131 devices are the brainy bunch. From Cranial Burs to Aneurysm Clips, it’s a neurological saga.

  • 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: Tools for Self-Help

Devices for personal use, totaling 24, are mostly over-the-counter goodies. Face Shields, Nitrile Gloves, and Radiation Protection Caps – it’s the self-help section.

  • 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): Celebrating Women’s Health

With 116 devices, this category dives into women’s health. From Birthing Beds to Breast Transilluminators, it’s a journey through the stages of womanhood.

  • 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: Focusing on Vision

Eye-related issues get a spotlight with 144 devices. Amsler Grids, Corneal Burr Manual Instruments, and Aqueous Humor Replacement Kits – it’s a vision-focused extravaganza.

  • 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: Bouncing Back

For those on the road to recovery, 144 devices are here to help. Acupressure Calf Bands, Back Row Exercisers, and Hydrotherapy Treadmills ensure a smooth recovery journey.

  • 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: Backing You Up

Supporting physical activities, these 38 devices ensure stability. Ankle Orthoses, Flotation Therapy Beds, and Neuro-Controlled Ambulation Exoskeletons – it’s a physical support party.

  • 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: Minimally Invasive Magic

These 71 devices, designed to be minimally invasive, redefine medical interventions. From Positron Cameras to Electrostatic X-Ray Imaging Systems, it’s a radiological revolution.

  • 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: Battling Musculoskeletal Woes

For musculoskeletal issues, 11 devices offer relief. Back braces, canes, and stairway chair lifts – it’s the musculoskeletal toolkit.

Dermatology and Plastic Surgery: Crafting Beauty

In this category, 56 devices treat skin conditions and aid in plastic surgery. Eye Pads, Suture Retention Devices, and Carbon Dioxide Lasers – it’s a beauty and wellness ensemble.

  • 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: Tiny Tools for Tiny Humans

Specifically designed for the little ones, with 137 devices. From Infant Limb Immobilizers to External Counterpulsation Systems, it’s a pediatric paradise.

  • 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: Tools for the Cancer Battle

For the warriors against cancer, 78 devices assist in staging, surgery, therapy, and palliative care. From Blepharoplasty Scissors to Flexible Video Bronchoscopes, it’s a cancer-fighting arsenal.

  • 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: Beams of Healing

Using high-energy radiation beams to battle cancer, these 102 devices redefine cancer treatment. Radiographic Protective Gloves, Laser Irradiation Therapy Kits, and Brain Manual Brachytherapy Applicators – it’s a cancer-healing saga.

  • 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: Treating Kidney Woes

For kidney-related issues, 39 devices take the stage. From Dialyser Connectors to Haemodialysis Concentrates, it’s a renal care rendezvous.

  • 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: The Brains Behind the Operation

Finally, in the software realm, 60 devices rule the digital domain. From Continuous Glucose Monitor Retrospective Data Analysis Software to Diabetic Retinopathy Detection Devices, it’s a software symphony.

  • 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.

Making Sense of Technicalities

Now that we’ve laid out the groundwork, let’s delve into the technicalities involved in CDSCO’s medical device classification. From the parameters considered to the criteria applied, we’ll unravel the complexities, making it crystal clear how each device finds its place in the grand scheme of medical regulations.

Implications for Medical Device Manufacturers

For those in the business of manufacturing medical devices, CDSCO’s medical device classification is not just a bureaucratic detail. It has real-world implications, influencing the procedures they need to follow, the forms they need to fill, and the standards they need to meet. We’ll break down these implications, ensuring manufacturers are well-equipped to navigate the regulatory landscape.

The Finale: A Harmonious Conclusion

CDSCO’s classification of medical devices in India is a crucial framework that shapes the regulatory landscape. The journey from the initial ambiguity to the clarifying notice in 2020 has paved the way for a clearer, more transparent system. Manufacturers, healthcare professionals, and consumers alike can now navigate the world of medical devices with a better understanding of the rules of engagement. Cheers to a clearer and safer future in the realm of medical technology!

In conclusion, this extensive list encompasses devices classified into four classes under the vigilant eye of CDSCO, following the Medical Devices Rules of 2017. Some categories, like software and dermatology, play it safe with no Class D devices, while others, like radiotherapy, dare to be risk-takers without any Class A devices. This compilation acts as a guiding light for manufacturing units and marketing companies, helping them navigate the labyrinth of medical device licensing. Cheers to the healing symphony!

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