What are Class D Medical Devices?

Class D Medical Devices

Class-D Medical Devices are intrusive surgical products and these products are meant to be used for a short period. These Class D Medical Devices expose high risk, have tricky patterns, and have straight access to the human body’s “Central Nervous System”. This category of medical devices is generally used for the diagnosis, detection, and correction of heart and central circulatory system issues.

List Of Class D Medical Devices

All the Class D Medical Devices with proper device description are mentioned below:-

Category – Anesthesiology

S.NoMedical Device NameIntended UseINDIA
1Electronic epidural space locator control unit A device intended to be used with an epidural needle and an electronic epidural space locator pressure-sensing set, to aid a user in locating the epidural needle tip within the epidural space for subsequent anesthesia administration. D
2Epidural anaesthesia kit A collection of devices intended to be used to deliver an analgesic or anesthetic agent to the epidural space for pain management. D
3Spinal needle bioimpedance navigation unit A device designed to transmit and receive electrical signals to/from a dedicated spinal needle and to analyze bioimpedance data in real-time, to predict needle tip locationD

Category – Pain Management 

S.NoMedical Device NameIntended UseINDIA
1Implantable intrathecal infusion pumpA device designed to be implanted in a patient for the storing and subarachnoid (intrathecal) administration of narcotics/drugs to manage intractable pain and muscle spasms of malignant or non-malignant origin.D
2Implantable lumbar neuromuscular electrical stimulation system The system is designed to deliver episodic electrical stimulation to nerves that innervate lumbar muscles to elicit contraction for the treatment of chronic low back pain (CLBP)D

Category – Cardiovascular

S.NoMedical Device NameIntended UseINDIA
1Ventricular bypass (assist) deviceA ventricular bypass (assist) device is a device that assists the left or right ventricle in maintaining circulatory blood flow. The device is either totally or partially implanted in the bodyD
2Implantable pacemaker pulse generatorAn implantable pacemaker pulse generator is a device that has a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. This device is used as a substitute for the heart’s intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders. This device may include triggered, inhibited, and asynchronous modes and is implanted in the human bodyD
3Pacemaker programmers.A pacemaker programmer is a device used to noninvasively change one or more of the electrical operating characteristics of a pacemaker.D
4Pacemaker repair orreplacement material.A pacemaker repair or replacement material is an adhesive, a sealant, a screw, a crimp, or any other material used to repair a pacemaker lead or to reconnect a pacemaker lead to a pacemaker pulse generatorD
5Carotid sinus nerve stimulatorA carotid sinus nerve stimulator is an implantable device used to decrease arterial pressure by stimulating Hering’s nerve at the carotid sinus.D
6Replacement heart valve.A replacement heart valve is a device intended to perform the function of any of the heart’s natural valves. This device includes valves constructed of prosthetic materials, biologic valves (e.g., porcine valves), or valves constructed of a combination of prosthetic and biologic materialsD
7Cardiopulmonary bypass pulsatile flow generator.A cardiopulmonary bypass pulsatile flow generator is an electrically and pneumatically operated device used to create pulsatile blood flow. The device is placed in a cardiopulmonary bypass circuit downstream from the oxygenatorD

Category – Dental 

S.NoMedical Device NameIntended UseINDIA
1Zinc polycarboxylate dental cement A non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between zinc oxide (ZnO) and aqueous solutions of polycarboxylic acid (e.g., polyacrylic acid).D

Category – ENT

S.NoMedical Device NameIntended UseINDIA
1Tympanic membrane contact hearing aid A tympanic membrane contact hearing aid is a prescription device that compensates for impaired hearing by vibrating the tympanic membrane through a transducer that is in direct contact with the tympanic membrane.C

Category – Gastroenterology

S.NoMedical Device NameIntended UseINDIA
1Fistula-repair biomatrix implant A sterile, bioabsorbable, animal-derived substance intended to be injected into a fistula tract (e.g., anal or rectal fistula) to close it by adding volume and promoting the ingrowth and neovascularization of host tissue.C
2Gastrointestinal anastomosis coupler, bioabsorbableAn implantable device intended to be used to join and transect excess tissue of gastrointestinal structures through the coupling of two ring-shaped components that are inserted into the ends of the segments to be attached. C

Category – Respiratory  

S.NoMedical Device NameIntended UseINDIA
1Implantable sleep apnoea treatment systemAn assembly of devices intended for home management of obstructive sleep apnoea (OSA) using an implanted stimulator to provide electrical stimulation to the hypoglossal nerve.C

Category – Neurological

S.NoMedical Device NameIntended UseINDIA
1Analgesic spinal cord electrical stimulation system Implantable device intended to treat acute and/or chronic intractable pain, where the use of drug therapy is undesirable or no longer effective.D
2Aneurysm clip.An aneurysm clip is a device used to occlude an intracranial aneurysm (a balloonlike sac formed on a blood vessel) to prevent it from bleeding or burstingD
3Antiseizure/psychiatric-therapy vagus nerve electrical stimulation systemAn implantable device intended to apply periodic electrical stimuli to the vagus nerve to help control seizures and/or to help treat psychiatric disorder symptoms (e.g., depression).
4Atrial cerebrospinal fluid catheterIntended to be implanted as the distal component of a ventriculoatrial shunt to channel cerebrospinal fluid (CSF) to the right atrium where it can be absorbed into the bodyD
5Bare-metal intracranial vascular stentIntended to be implanted into the base or parent artery of an intracranial aneurysm.D
6Bladder/bowel-evacuation implantable electrical stimulation systemIntended to empty the urinary bladder and/or the bowels by applying electrical stimuli typically to the cone-shaped end of the spinal cord (conus medularis).D
7Brain-responsive electrical stimulation system Intended to continuously monitor brain activity and deliver electrical stimuli to seizure foci in response to neurological disorders (e.g., epilepsy).D
8Cardiac-therapy vagus nerve electrical stimulation systemIntended to apply periodic stimuli to the vagus nerve as a treatment for cardiac failure.D
9Cerebral perfusion catheterIntended for brain protection during profound hypothermic circulatory arrest during aortic surgeryD
10Coma-arousal vagus nerve electrical stimulation systemIntended to apply periodic stimuli to the vagus nerve for the purpose of exciting the patient to arousal from a vegetative state (i.e., a deep coma).D
11Cortical electrode.A cortical electrode is an electrode which is temporarily placed on the surface of the brain for stimulating the brain or recording the brain’s electrical activityD
12Cranial electrotherapy stimulatorA cranial electrotherapy stimulator is a device that applies electrical current to a patient’s head to treat insomnia, depression, or anxiety D
13Cryogenic surgical deviceA cryogenic surgical device is a device used to destroy nervous tissue or produce lesions in nervous tissue by the application of extreme cold to the selected site D
14Deep brain electrical stimulation system Designed to apply electrical stimuli to specific areas of the deep brain for the treatment of movement disorders, psychiatric disorders and/or to treat chronic, severe, intractable pain.D
15Diskectomy system, percutaneous, automaticIntended for the percutaneous (through the skin) removal of the nucleus pulposus from the lumbar disc.D
16Extramuscular diaphragm/phrenic nerve electrical stimulation systemIntended to provide ventilatory support to a patient with diaphragm dysfunction of neuromuscular origin through electrical stimulation of the phrenic nerve, to contract the diaphragm rhythmically (using extramuscular electrodes) and cause the patient to draw breath in a manner similar to natural breathing.D
17Gait-enhancement electrical stimulation system, implantableIntended to improve the gait in a patient suffering from partial paralysis of the lower extremities or other neuromuscular disorders by applying internal electrical simulationD
18Human dura materHuman dura mater is human pachymeninx tissue intended to repair defects in human dura materD
19Implantable intrathecal infusion pump, programmable Intended to be implanted in a patient for the storing and subarachnoid (intrathecal) administration of narcotics/drugs (e.g., morphine sulfate, baclofen) to manage intractable pain and muscle spasms of malignant or non-malignant originD
20Implantable lumbar neuromuscular electrical stimulation system pulse generatorIntended to deliver episodic electrical stimulation to nerves that innervate lumbar muscles to elicit contraction for the treatment of chronic low back pain (CLBP).D
21Implantable pulse generator mesh bag, bioabsorbableIntended to envelop an implantable pulse generator (IPG) (e.g., cardiac pacemaker/defibrillator, neurostimulator) to stabilize the implant in the subcutaneous pocket in which it is implanted.D
22Implantable sleep apnoea treatment systemIntended to deliver electrical stimulation to the hypoglossal nerve [targeted hypoglossal nerve stimulation (THN)] for the home management of obstructive sleep apnoea (OSA).D
23Implantable sleep apnoea treatment system, respirationsensing Intended to deliver electrical stimulation in synchronous with respiration during sleep, to the hypoglossal nerve [targeted hypoglossal nerve stimulation (THN)] for the home management of obstructive sleep apnoea (OSA).D
24Implanted cerebellar stimulatorAn implanted cerebellar stimulator is a device used to stimulate electrically a patient’s cerebellar cortex for the treatment of intractable epilepsy, spasticity, and some movement disorders. The stimulator consists of an implanted receiver with electrodes that are placed on the patient’s cerebellum and an external transmitter for transmitting the stimulating pulses across the patient’s skin to the implanted receiverD
25Implanted diaphragmatic/phrenic nerve stimulator. An implanted diaphragmatic/phrenic nerve stimulator is a device that provides electrical stimulation of a patient’s phrenic nerve to contract the diaphragm rhythmically and produce breathing in patients who have hypoventilation (a state in which an abnormally low amount of air enters the lungs) caused by brain stem disease, high cervical spinal cord injury, or chronic lung disease. The stimulator consists of an implanted receiver with electrodes that are placed around the patient’s phrenic nerve and an external transmitter for transmitting the stimulating pulses across the patient’s skin to the implanted receiverD
26Implanted intracerebral/subcortical stimulator for pain relief.An implanted intracerebral/subcortical stimulator for pain relief is a device that applies electrical current to subsurface areas of a patient’s brain to treat severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed within a patient’s brain and an external transmitter for transmitting the stimulating pulses across the patient’s skin to the implanted receiverD
27Implanted neuromuscular stimulator. An implanted neuromuscular stimulator is a device that provides electrical stimulation to a patient’s peroneal or femoral nerve to cause muscles in the leg to contract, thus improving the gait in a patient with a paralyzed leg. The stimulator consists of an implanted receiver with electrodes that are placed around a patient’s nerve and an external transmitter for transmitting the stimulating pulses across the patient’s skin to the implanted receiver. The external transmitter is activated by a switch in the heel in the patient’s shoeD
28Implanted spinal cord stimulator for bladder evacuation.An implanted spinal cord stimulator for bladder evacuation is an electrical stimulator used to empty the bladder of a paraplegic patient who has a complete transection of the spinal cord and who is unable to empty his or her bladder by reflex means or by the intermittent use of catheters. The stimulator consists of an implanted receiver with electrodes that are placed on the conus medullaris portion of the patient’s spinal cord and an external transmitter for transmitting the stimulating pulses across the patient’s skin to the implanted receiverD
29Intracranial pressure monitor deviceIntended for intermittent or continuous measurement and display of intracranial pressure (ICP). It is used in conjunction with an invasive intracranial deviceD
30Intramuscular diaphragm/phrenic nerve electrical stimulation system Intended to provide ventilatory support to a patient with diaphragm dysfunction of neuromuscular origin through electrical stimulation of the phrenic nerve to contract the diaphragm rhythmically (using intramuscular electrodes) and cause the patient to draw breath in a manner similar to natural breathing.D
31Meningeal prosthesis Intended to repair the meningeal membrane (meninges).D
32Nerve guide, bioabsorbable, animal-derived The collagen matrix material is intended to be used to create a tunnel through which a discontinuous peripheral nerve can regenerate to bridge the proximal and distal nerve stumps.D
33Nerve guide, bioabsorbable, synthetic Synthetic material is intended to be used to create a tunnel through which a discontinuous peripheral nerve can regenerate to bridge the proximal and distal nerve stumps. D
34Nerve guide, nonbioabsorbableNon-bioabsorbable material is intended to be used to create a tunnel through which a discontinuous peripheral nerve can regenerate to bridge the proximal and distal nerve stumps.D
35RheoencephalographA rheoencephalograph is a device used to estimate a patient’s cerebral circulation (blood flow in the brain) by electrical impedance methods with direct electrical connections to the scalp or neck areaD
36Scoliosis-treatment electrical stimulation systemIntended to apply electrical stimuli to the spinal musculature to produce a force that stabilizes or limits the progression of the spinal lateral curvature (i.e., scoliosis).D
37Stereotactic radiosurgical system Intended to deliver a therapeutic radiation dose to an anatomical region from external beams produced from multiple radionuclide sources arranged in a fixed focal point collimated array; typically used to treat brain, neck, breast, and spinal tumors.D
38Tibial nerve percutaneous incontinence-control electrical stimulation system Intended to treat urinary and/or faecal incontinence with electrical stimuli applied to the sacral nerve via percutaneous tibial nerve stimulation (PTNS)D
39Transvenous phrenic nerve electrical stimulation control unit Intended to configure/deliver stimulation of the phrenic nerve, via a transvenous electrode, to cause contraction of the diaphragm in conjunction with mechanical ventilation to assist earlier ventilation weaning.D

Category – Obstetrical and Gynecological

S.NoMedical Device NameIntended UseINDIA
1Fallopian tube occlusion insertContraceptive implantable device implanted into the uterine end of the fallopian tubes to function as a contraceptive by obstructing the natural fallopian tube passageD

Category – Ophthalmic

S.NoMedical Device NameIntended UseINDIA
1Aqueous/vitreous humour replacement medium kitA collection of sterile devices, including a fluid or semifluid substance, used in combination to replace the fluid of the eye.D

Category – Interventional Radiology

S.NoMedical Device NameIntended UseINDIA
1Transilluminator for breast evaluation A transilluminator, also known as a diaphanoscope or lightscanner, is an electrically powered device that uses low intensity emissions of visible light and near-infrared radiation (approximately 700-1050 nanometers (nm)), transmitted through the breast, to visualize translucent tissue for the diagnosis of cancer, other conditions, diseases, or abnormalities. D

Category – Pediatrics and Neonatology

S.NoMedical Device NameIntended UseINDIA
1Craniofacial bone screw, bioabsorbableA small, sterile, threaded rod with a slotted head used for craniofacial bone (including the maxilla and/or mandible) fracture fixation by being screwed into bone to hold plates to bone or to provide direct interfragmentary stabilization of bone; it is made of a material that is chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers). The device may be selfdrilling/self-tapping. Its uses include repair of orbital fractures and fractures around the cranial sinuses, paediatric reconstructive surgery, and craniotomy flap fixationD
2Polyglyconate sutureA sterile, single-strand (monofilament), synthetic, bioabsorbable thread made from polyglyconate (prepared from a copolymer of glycolic acid and trimethylene carbonate) intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues (especially in paediatric cardiovascular surgeries). It may include an attached needle intended to be disposed of after single use. The thread provides extended temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis. This is a single-use deviceD

Category – Oncology

S.NoMedical Device NameIntended UseINDIA
1Alternating electric field antimitotic cancer treatment systemAn assembly of portable devices designed to apply low-intensity, intermediate frequency (100-300 kHz) alternating electric fields to treat certain forms of recurrent or newly-diagnosed cancer; typically glioblastoma multiforme (GBM) [malignant brain tumour]D
2Brain brachytherapy system applicator, manual A device specifically designed to be used in radiation therapy treatments of the brain. It has individual or modular device configurations designed to facilitate manual placement, e.g., puncture, endoscopically guided placement or diagnostic imaging guided placement, and removal of single or multiple radioactive sources at a treatment site within the brain. D
3Brain brachytherapy system applicator, remote-afterloadingA remote afterloading brachytherapy applicator specifically designed for use in radiation therapy treatments of the brain. It is designed for temporary implantation within the body and serves as a guide for computer-controlled placement and removal of single or multiple radioactive sources in the brain. D
4Breast transilluminatorA mains electricity (AC-powered) transilluminating device with a built-in light source using low-intensity emissions of visible light and near-infrared radiation (700 to 1050 nm) that is transmitted through the female breast to visualize translucent tissue for the diagnosis of cancer, or other conditions, diseases or abnormalities. This device may also be known as a diaphanoscope.D
5Coronary artery brachytherapy system applicator, manual afterloadingA sterile flexible tube intended to deliver/remove radiation therapy sources into a coronary artery, typically into the lumen of an implanted stent, as part of a manual-afterloading brachytherapy system. It is introduced into the patient and subsequently connected to the brachytherapy system source transfer device; it includes radiopaque markers to monitor the position of the radiation source. Disposable devices associated with the procedure may be included (e.g., syringes, connectors). This is a single-use device.D
6Extravascular-circulation hyperthermia systemAn assembly of devices designed to produce and control heated fluids circulated within a vessel applied to the body (e.g., vest, mattress, jacket, band, pad, body wrap, catheter, probe) for systemic or localized heating to treat malignant tumours, benign growths, or other disease-related conditions.D
7Extravascular-circulation hyperthermia system applicator, intracorporeaA component of a hyperthermia system that typically consists of catheterenclosed tubing which is introduced into the body either manually or endoscopically. Heated fluid is circulated through the applicator’s tubing for localized heating to treat malignant tumours, benign growths, or other diseaserelated conditions. The applicator (also called an interstitial applicator or probe) typically includes a thermometry component that monitors the temperature of the applicator during operation; it also includes tubing, cables, and connectors that interface with the hyperthermia system’s control unit during treatments. It is typically used in an oncology department. This is a single-use device.D
8Flexible ultrasound bronchoscopeAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the trachea, bronchi, and lungs. It is inserted through the mouth or nose during bronchoscopy. Anatomical images are transmitted to the user by the device typically through a fibreoptic bundle or a video system, and an ultrasound probe. The probe may be built-in or inserted through a dedicated lumen so that its distal tip is positioned adjacent to that of the endoscope. It is commonly used to diagnose lung infections, pneumonia, or lung cancer, and allows physicians to view the insides of the lungs and take biopsies and samples of secretions. This is a reusable device.D

Category – Radiotherapy

S.NoMedical Device NameIntended UseINDIA
1Absorbable tissue spacer for radiotherapy An absorbable material used to reduce radiation exposure of normal tissue during radiotherapy by implanting surgically or percutaneously between tissue, internal organs, etc. , to make a space between the malignant tumor and normal tissue.D
2Blood vessel manual brachytherapy applicatorA manual brachytherapy applicator designed exclusively for blood vessel radiotherapy. Most commonly, it is used to prevent formation of plaque, stenosis and restenosis in blood vessels after surgery. A single or module device designed to facilitate manual placement (placement and removal under endoscopy or using an image diagnostic system) of single or multiple therapeutic radiation sources in the treatment site.D
3Blood vessel remote afterloading brachytherapy applicatorA remote controlled brachytherapy applicator designed exclusively for radiotherapy in blood vessels. This treatment is used to prevent plaque formation. and stenosis in blood vessels after surgery. It is designed for temporary implantation in a blood vessel, and serves as a guide for computer-controlled temporary placement and removal of single or multiple therapeutic radiation sources at treatment sites. D
4Brain manual brachytherapy applicatorAn applicator specifically designed for brain radiotherapy. A single or module applicator designed to facilitate manual placement (puncture, placement under endoscopy, or placement and removal using an image diagnostic system) of single or multiple therapeutic radiation sources in the brain.D
5Brain remote afterloading brachytherapy applicatorA remote controlled brachytherapy applicator designed exclusively for brain radiotherapy for temporary implantation in the body. It serves as a computer-controlled guide for temporary placement and removal of a single or multiple therapeutic radiation sources in the brain.D
6Central circulatory general-purpose manual brachytherapy applicatorA single or module applicator designed to facilitate manual placement (puncture, local placement, placement under endoscopy or placement and removal using an image diagnostic system) of single or multiple therapeutic radiation sources in treatment sites in the central circulatory system.D
7Central circulatory general-purpose remote afterloading brachytherapy applicatorIntended to be temporarily implanted in the body. It serves as a guide for computer-controlled temporary placement and removal of a single or multiple therapeutic radiation sources at treatment sites in the central circulatory system. D
8Central circulatory manual brachytherapy therapeutic radionuclide systemA device that places a radiation source manually or automatically at the treatment site in the central circulatory system for providing a required radiation dose during radiotherapy. This device does not equip a remotely controlled radiation source transporter.D
9Central circulatory permanent implant manual brachytherapy therapeutic radionuclide sourceA device for the central circulatory system to be placed permanently in the body for radiotherapy which is necessary for treatment and symptomatic therapy, and uses natural radioisotopes or radioisotopes produced by an accelerator or a nuclear reactor. The radiation source, which is permanently placed manually, is designed to achieve compatibility with tissues. The radiation source can be selected from the following forms – e.g., microsphere, globe, stent, seed, and wire-in order to generate low-energy photons, beta particles, or alpha particlesD
10Central circulatory remote afterloading brachytherapy therapeutic radionuclide source A device for the central circulatory system used as a radiation source to deliver a high or low dose rate with an afterloading brachytherapy device designed for radiotherapy which is necessary for treatment and symptomatic therapy, and uses natural radioisotopes or radioisotopes produced by an accelerator or a nuclear reactor. D
11Central circulatory remote afterloading brachytherapy therapeutic radionuclide system A device that places a radiation source temporarily at the treatment site in the central circulatory system for providing a required radiation dose during radiotherapy. This device equips a remotely controlled radiation source transporterD
12Central circulatory temporary placement manual brachytherapy therapeutic radionuclide sourceA device for the central circulatory system that uses natural radioisotopes or radioisotopes produced by an accelerator or a nuclear reactor, and is placed in the body temporarily, and removed after the pre-determined treatment period. The radiation source, which is temporarily inserted manually, is supplied in various forms – e.g., encapsulated, sealed, plated, foiled, or embedded. D

Category – Nephrology and Renal Care

S.No Medical Device NameIntended UseINDIA
1Absorbable peritoneum catheter cuffIntended to maintain stable contact between the skin and the peritoneal dialysis catheter, and prevent bacterial invasion from the outlet. It is embedded subcutaneously at the outlet of the peritoneal dialysis catheter. D
2Collagen-containing peritoneum absorbable catheter cuffA cuff that consists of biodegradable porous material containing collagen, is intended to be embedded subcutaneously at the outlet of the peritoneal dialysis catheter. D

Refrence – http://cdscomdonline.gov.in/

What is the Process of Class D Medical Devices Registration In India?

The easy process for Class D Medical Devices Registration in India is mentioned below:-

  • Sugam Registry – Users need to visit Sugam Portal and register there.
  • Plan out the Application – First draft the application for the easy process of Class-D Medical Device Registration.
  • Sync Documents – Now verify the checklist of Form MD-8 and following procedure upload all the documents.
  • Payment – Pay the Registration Government Fees.
  • Application Submission – To get the license one surely needs to fill out the application on the SUGAM online portal.
  • CDSCO Reviewing Procedure – After all the steps CDSCO will review the application.
  • Inspection Process – The Medical Device inspection officer will inspect the manufacturing or production site. The result time, where will be decided if you are ticking all the checklists of the process.
  • License Issuing – Here in this step CDSCO will issue the License in Form MD-9.

To Know a detailed version of Class-C Medical Devices check out this https://medicaldeviceregistration.com/list-of-class-c-medical-devices/

FAQ

What are Class-D Medical Devices?

Class-D Medical Devices are very risky medical devices and pose a high amount of danger. Class-C medical devices also came in the high-risk category, but eventually, Class-D medical devices became more risky than the other three classes. If you are willing to apply for a medical device certificate, then click on it.

What are Class-A Class-B Class-C and Class-D Medical Devices?

Class-A and Class-B Medical Devices are less to moderate in risk. Class-C and Class-D Medical Devices are very high and more risky medical devices. The state licensing authority issues the license and you must get the application for the production of these medical devices.

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