Medical Device Rules India, 2017: Classification of Medical Devices Regulations and Regulatory Approval for Registration

The classification of medical devices rules along with regulatory approval and registration by the CDSCO is under the control of Drug Controller General of India (DCGI). All medical devices in India follow a regulatory framework that is based on the drug regulations under the Drugs and Cosmetic Act (1940) and Drugs and Cosmetic Rules (1945).

The Health Ministry of India has published new Medical Device and IVD regulations to enhance the country’s Drugs and Cosmetics Act for creating effective regulations. The government has notified Medical Devices Rules, 2017 on 31.01.2017 and it will come into force on January 1, 2018. The suggested medical device rules necessary for regulatory approval impact of the Medical device and IVD sector.

New Medical Devices Rules India, 2017 -Key Features for Regulatory approvals and Registrations:

It will be for the first time that there will be no requirement of periodic renewal of licenses/registrations. Accordingly, manufacturing and import licences will remain valid till these are suspended or cancelled or surrendered.
Further, the entire process starting from submission of application to grant of permission/licence will be processed through online electronic platform.
The registration document review, submission & tracking have become much simpler, efficient & transparent with the SUGAM system.
Timelines have been defined for most activities at the regulators end.
The new Rules “Medical Devices Rules, 2017”will help in developing quality standardization in the regulations of framework at par with international standards.
It has been made easier to apply for change notifications once the registrations certificate is obtained. This can be done in the section “Post Approval Change”.

Regulatory approvals mechanism:

The new regulations will balance the usage of medical devices rules with International standards so as to smoothen manufacturing & importing of medical devices. National Medical Device Authority will receive authorization to promote the local medical device sector which includes safety standards, specific price limits, price control policy for surgical instruments.

At present there are 22 notified Medical devices under the Drugs & Cosmetics Act, 1940, and need to be registered with the CDSCO (Regulatory Body of India).

Sl: No	Name of the Devices
1	Disposable Hypodermic Syringes
2	Disposable Hypodermic Needles
3	Disposable Perfusion Sets
4	In vitro Diagnostic Devices for HIV, HbsAg and HCV
5	Cardiac Stents
6	Drug Eluting Stents
7	Catheters
8	Intra Ocular Lenses
9	I.V. Cannulae
10	Bone Cements
11	Heart Valves
12	Scalp Vein Set
13	Orthopaedic Implants
14	Internal Prosthetic Replacements
15	Ablation Device

Medical devices under the new Rules “Medical Devices Rules, 2017”are classified as per Global Harmonization Task Force (GHTF) based on associated risks,

Class A (low risk)
Class B (low moderate risk)
Class C (moderate high risk)
Class D (high risk)

Authority for Regulatory approval along with Registration of Medical Devices:

Class B, Class C and Class D: The Central Licensing Class A and Class B: The State Licensing Authority is for registrations matters relating to these devices. Authority is responsible for providing the required licenses for the import and manufacture of Class C and Class D products. Companies those want to manufacture Class C and Class D along with Class A and Class B can send applications.

The manufacturers of medical devices will be required to meet risk proportionate regulatory requirements that have been specified in the Rules.

As per the guidelines in the “The Medical Devices Rules, 2017” the list of Medical Devices and IVDs along with their risk based classification is announced in CDSCO Notice dated 29^th June 2017.

LIST OF MEDICAL DEVICES ALONG WITH THEIR RISK CLASS

The medical devices classification has larger groups of devices such as cannulas and stents into more specific sub groups such as ureteral stents, coronary stents. CDSCO have the classification of new sub groups using risk analysis methods required by the Medical Devices Rules 2017.

The below table is the list of medical devices along with their risk class

Class A Medical Devices:

S.No	Notified Device Category/Drug	Device Name	Risk Class	General Intended Use
1	Catheters	Nasopharyngeal Catheter / Nasopharyngeal	Class A	A catheter (for adults) passed through the nares and advanced to the depth of the nasopharynx to remove air choke or obstruction. AResuscitator.
2	Disposable Perfusion Sets	Y-Connector as an accessory to perfusion sets	Class A	It can be used to connect to a perfusion sets or catheter for infusion of contrast media etc.
3	Surgical Dressings	Surgical Dressings	Class A	Dressing aerosol, non-adherent, dressing, periodontal, kit, dressing pad, dressing.
4	Surgical Dressings	Umbilical occlusion device	Class A	These devices may be a clip, tie, tape, or other article used to close the blood vessels in the umbilical cord of a newborn infant.
5	Surgical Dressings	Bolster Suture	Class A	Non-latex plastic bolsters are used to hinder pressure of any temporary suture against the body during surgery.
6	Surgical Dressings	Alcohol Swabs	Class A	It is a single use, sterile device containing 70% Isopropyl alcohol used for scrubbing and allowing drying and will disinfect needless access sites prior to use.

Class B Medical Devices:

S.No	Notified Device Category/Drug	Device Name	Risk Class	General Intended Use
1	Catheters	Fiberoptic Oximeter Catheter	Class B	Intended for monitoring the balance between oxygen delivery and consumption at the bedside
2	Catheters	A-V Shunt or Fistula Adapter	Class B	A blood access device and accessories is a device intended to provide access to a patient’s blood for haemodialysis or other chronic uses.
3	Catheters	Transcervical(Aminoscope) Endoscope and accessories	Class B	It is a device designed to permit direct viewing of the foetus and amniotic sac by means of an open tube introduced into the uterus through the cervix.
4	Catheters	Forceps, endoscopic	Class B	Grasping Forceps device is intended to be used to grasp tissue, retrieve foreign bodies, and remove tissue from within the gastrointestinal tract.
5	Catheters	Vessel Dialator for percutaneous Catheterization	Class B	A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.
6	Catheters	Tracheobronchial Suction Catheter	Class B	Clearing the airways of mucus, pus, or aspirated materials to improve oxygenation and ventilation.
7	Catheters	Cervical Drain	Class B	The device is used to avoid postoperative wound and respiratory complications such as excessive edema, hematoma, infection, re-intubation, delayed extubation, or respiratory distress
8	Catheters	Rectal Balloon	Class B	Reducing the intrafraction motion and improving the sparing of rectal wall by reducing the rectal volume in the high dose region, resulting in significant reduction in rectal toxicity.
9	Catheters	Biliary Stone Retrieval Basket	Class B	Intend to extract stones in an antegrade fashion through an ampullary previously treated sphincterotomy or less commonly with balloon dilation
10	Catheters	Tracheostomy Tube/Tracheal Tube	Class B	A breathing tube inserted into a tracheotomyused to obtain a closed circuit for ventilation
11	Catheters	Vial Adapter	Class B	It is indicated to allow multiple needleless access to injection medication vials for transfer or withdrawal of fluids from the vial.
12	Catheters	Suprapubic, non -disposable Cannula	Class B	an emergency measure for the relief of acute urinary retention or condition which require temporary and permanent drainage of bladder.
13	Catheters	Esophageal obturator	Class B	Inserted through a patient’s mouth to aid ventilation of the patient during emergency resuscitation by occluding (blocking) the esophagus, thereby permitting positive pressure ventilation through the trachea.
14	Catheters	Balloon Catheter for Retinal Reattachment	Class B	An instrument for reattachment of a detached retina to the inner wall of the eyeball. It can be inserted into the interior of the eyeball.
15	Catheters	Gastric, Colonic, etc.) Irrigation and Aspiration Catheter	Class B	Used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract.
16	Catheters	Suction Tip and Catheter	Class B	Suction Catheters feature a whistle tip and a thumb control port for precise and accurate suctioning.
17	Catheters	Angiographic Catheter	Class B	Designed to provide a pathway for delivering contrast media to selected sites in the device vascular system including the carotid arteries.
18	Catheters	Arterial Catheter	Class B	Intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature.
19	Catheters	Balloon Type Catheter	Class B	“Soft” catheter with an inflatable “balloon” at its tip which is used during a catheterization procedure to enlarge a narrow opening or passage within the body.
20	Catheters	Balloon Dialation Vessel Catheter	Class B	Intended for use in Percutaneous Transluminal Angioplasty of the renal, tibial, popliteal, femoral and peroneal arteries. These catheters are not for use in coronary arteries.
21	Catheters	Bartholin Gland Catheter	Class B	Catheter is used for the treatmenti of abscesses and cysts of the Hartholin gland.
22	Catheters	Bronchography Catheter	Class B	Intended to deliver therapeutic and diagnostic agents that are indicated or labeled for airway, tracheal or
23	Catheters	Cholangiography Catheter	Class B	Diagnostic evaluation of the bile ducts during laparoscopic cholecystectomy procedures.
24	Catheters	Anesthetic Conduction Catheter	Class B	An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia
25	Catheters	Continuous Flush Catheter	Class B	Intended for the controlled and selective infusion of
26	Catheters	Continous Irrigation Catheter	Class B	Intended to be used to introduce fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions.
27	Catheters	Coude Catheters	Class B	It is a urinary catheter, It may be used to inject liquids used for treatment or diagnosis of bladder conditions.
28	Catheters	Depezzer Catheter	Class B	A tubular, flexible instrument, passed through body channels for withdrawal of fluids from a body cavity.
29	Catheters	Double Female Urethrographic Catheter	Class B	Intended for vascular access infusion and withdrawal of blood, blood products, and fluids, plasma pheresis, hyperalimentation, central venous blood sampling and continuous and intermittent drag infusion.
30	Catheters	Epidural Catheter	Class B	Epidural catheter is a very thin, flexible tube that is implanted into spine
31	Catheters	Esophageal Balloon Catheter	Class B	intended for use in adult and adolescent populations
32	Catheters	Eustachian Catheter	Class B	It is used to test Eustachian tube patency
33	Catheters	Guiding Catheter	Class B	The guide catheter provides support for device advancement .
34	Catheters	Haemodialysis Catheter	Class B	A catheter used for exchanging blood to and from the haemodialysis machine from the patient.
35	Catheters	Intramuscular Pressure Monitoring Catheter	Class B	A modified fibre optic transducer-tipped catheter system for measuring intramuscular pressures during exercise was determined.
36	Catheters	Intravenous Catheter	Class B	A catheter that is inserted into a vein for supplying medications or nutrients directly into the bloodstream or for diagnostic purposes such as studying blood pressure
37	Catheters	Jejunostomy Catheter	Class B	Used for intraoperative feeding jejunostomy
38	Catheters	Multiple Lumen Catheter	Class B	Intended for monitoring central venous pressure (CVP), sampling blood, and simultaneous administration of multiple IV solutions or drugs.
39	Catheters	Nasal Oxygen Catheter	Class B	It is a device used to deliver supplemental oxygen or increased airflow to a patient or person in need of respiratory help.
40	Catheters	Nephrostomy Catheter	Class B	A nephrostomy is a tube that’s used to drain urine from a kidney into a bag outside the body.
41	Catheters	Peritoneal Dialysis Catheter	Class B	That allows dialysis fluid to enter the abdominal cavity, dwell inside for a while, and then drain back out again
42	Catheters	Radiographic (Non Vascular) Catheter	Class B	Interventional radiologists obtain images using needles and narrow tubes called catheters, rather than by making large incisions into the body as in traditional surgery.
43	Catheters	Rectal Catheter	Class B	It is inserted into the rectum in order to relieve flatulence which has been chronic and which has not been alleviated by other methods.
44	Catheters	Retention Type Catheter	Class B	This type of catheter is placed into the bladder and secured there for a period of time.
45	Catheters	Retention Type Balloon Catheter	Class B	It has a balloon at the distal end, which is inflated with sterile water or saline to prevent the catheter from slipping out of the bladder
46	Catheters	Salpngography Catheter	Class B	Used for injection of contrast medium into the fallopian tube(s) for selective salpingography.
47	Catheters	Single Needle Hemodialysis Catheter/Blood lines	Class B	The single-needle dialysis, in which case only one cannula or a single-lumen catheter is used to access the blood
48	Catheters	Straight Catheter	Class B	It is used in patients with neurogenic bladder or spinal cord injury, lessens the risk of urinary tract infection
49	Catheters	Subclavian Catheter	Class B	Catheters can be placed in veins in the neck (internal jugular vein), chest (subclavian vein or auxiliary vein)
50	Catheters	Suprapubic Catheter	Class B	A suprapubic catheter is a thin, sterile tube used to drain urine from bladder.
51	Catheters	Umblical Artery Catheter	Class B	Umbilical artery catheterization provides direct access to the arterial blood supply and allows accurate measurement of arterial blood pressure a source of arterial blood sampling, and intravascular access for fluids and medications
52	Catheters	Upper Urinary Tract Catheter	Class B	The catheter to the bladder and subsequently to the upper urinary tract
53	Catheters	Urethral Catheter/Nelaton Catheter/ Foley Catheter	Class B	A long, small gauge catheter designed for insertion directly into a ureter, either through the urethra andbladder or posteriorly via the kidney.
54	Catheters	Urethrographic Male Catheter	Class B	A catheter used to pass into a man’s bladder.
55	Catheters	Chorionic Villus Sampling Catheter	Class B	An ultrasound guides a thin catheter through the cervix to your placenta. The chorionic villi cells are gently suctioned into the catheter.
56	Catheters	Sclerotherapy Needle/ Catheter	Class B	Sclerotherapy Needles are designed to provide access for injection therapy applications and may also be used for polypectomy and endoscopic mucosal resection (EMR)
57	Catheters	Water Jet Renal Catheter	Class B	A device used to dislodge stones from renal calyces (recesses of the pelvis of the kidney) by means of a pressurized stream of water through a conduit.
58	Catheters	Oximetry catheters, Oximetry Paceport catheter	Class B	It is indicated for the assessment of a patient’s hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring, cardiac output determination, continuous mixed venous oxygen saturation monitoring, and for infusing solutions.
59	Catheters	Flow Directed Catheter	Class B	Used for venous sampling and pressure monitoring.
60	Catheters	Ultrasonic maging Catheter	Class B	intended for ultrasound examination of peripheral pathology only
61	Catheters	Endoscopic Ligation Devices	Class B	It is used for proximal and distal ligation of vessels during endoscopic vessel harvesting procedures.
62	Catheters	Dialysate Tubing and Connector	Class B	A tubing connector adapted for peritoneal dialysis connections between tubing sets and containers of dialysate
63	Catheters	Urinary Drainage Unit	Class B	A closed urinary drainage system consists of a catheter inserted into the urinary bladder and connected via tubing to a drainage bag
64	Catheters	In-Vitro Fertilization/ Embryo Transfer Catheter	Class B	A cellular transfer catheter is provided for implantation of cellular material into the uterus of a patient
65	Catheters	Sclerotherapy Needle/ Catheter	Class B	It is designed to provide access for injection therapy applications and may also be used for polypectomy and endoscopic
66	Catheters	Fluid Delivery tubing	Class B	Tube used to deliver fluid in body
67	Catheters	Colon Tube	Class B	Colon Tubes also called “Tips” or even Catheters are inserted from the anus, through the rectum to deliver your enema solution into the colon (large intestine).
68	Catheters	Connecting Tube	Class B	Used to provide connection to a drainage bag.
69	Catheters	Decompression Tube	Class B	Decompression using a rectal tube may assist in the treatment only if the sigmoid colon is involved.
70	Catheters	Double Lumen for intestinal Decompression and/or Intubation Tube	Class B	Tracheal intubation, usually simply referred to as intubation, is the placement of a flexible plastic tube into the trachea (windpipe) to maintain an open airway or to serve as a conduit through which to administer certain drugs.
71	Catheters	Closed Wound Drainage Tube or System	Class B	A surgical drain is a tube used to remove pus, blood or other fluids from a wound. They are commonly placed by surgeons or interventional radiologists.
72	Catheters	Oesophageal Blakemore Tube	Class B	It is a medical device inserted through the nose or mouth and used occasionally in the management of upper gastrointestinal hemorrhage due to oesophageal varices .
73	Catheters	Oesophageal Sengtaken Tube	Class B	It is used only in emergencies where bleeding from presumed varices is impossible to control with medication alone
74	Catheters	Feeding Tube	Class B	A feeding tube is a device that’s inserted into your stomach through your abdomen. It’s used to supply nutrition when you have trouble eating
75	Catheters	Gastro- Enterostomy Tube	Class B	Tube is placed through the abdominal wall into the stomach and then through the duodenum into the jejunum.
76	Catheters	Gastrointestinal Tube	Class B	A gastrostomy tube (also called a G-tube) is a tube inserted through the abdomen that delivers nutrition directly to the stomach
77	Catheters	Heart-Lung Bypass Unit Tube	Class B	A tube will be placed in your heart to drain blood to the machine.
78	Catheters	Levine Tube	Class B	Used for the aspiration of gastric and intestinal contents and administration of tube feedings or medications.
79	Catheters	NasoGastric Tube/ Ryles Tube	Class B	It is a special tube that carries food and medicine to the stomach through the nose. It can be used for all feedings or for giving a person extra calories
80	Catheters	Nephrostomy Tube	Class B	The nephrostomy tube drains urine from kidney into a collecting bag outside the body.
81	Catheters	Orthodontic Tube	Class B	An orthodontic small metal part welded on the outside of a molar bank, which contains slots to holdarchwires, lip bumpers, facebows and other devices used to move the teeth.
82	Catheters	Rectal Tube	Class B	A rectal tube, also called a rectal catheter, is a long slender tube which is inserted into the rectum in order to relieve flatulence .
83	Catheters	Stomach Evaculator(Gastric Lavage) Tube	Class B	Passage of a tube via the mouth or nose down into the stomach followed by sequential administration and removal of small volumes of liquid.
84	Catheters	Tonsil Suction Tube	Class B	Used to suck out stones in tonsils
85	Catheters	Tracheal (Endotracheal) Tube	Class B	Inserts the tube with the help of a laryngoscope, an instrument that permits to see the upper portion of the trachea, just below the vocal cords.
86	Catheters	Closed Suction System	Class B	It is intended for endotracheal suctioning to provide a patient airway by removing excess fluids, secretions, exudates and transudate through the artificial airway.
87	Catheters	Endolymphatic Shunt Tube	Class B	During a surgical procedure in which it is placed in the membranous labyrinth of the inner ear to drain excess fluid.
88	Catheters	Orthodontic Guide Wire	Class B	A wire conforming to the alveolar or dental arch that can be used with dental braces as a source of force in correcting irregularities in the position of the teeth.
89	Disinfectants	Disinfectants	Class B	An agent that destroys pathogenic and other kinds of microorganisms by chemical or physical means. A disinfectant destroys most recognized pathogenic microorganisms, but not necessarily all microbial forms, such as bacterial spores. It is intended to disinfect a medical device.
90	Disposable Hypodermic Needles	Aspiration Needle	Class B	Used for either laparoscopic aspiration or injection
91	Disposable Hypodermic Needles	Aspiration and Injection Needle	Class B	A thin needle is inserted into an area of abnormal-appearing tissue or body fluid. As with other types of biopsies, the sample collected during fine needle aspiration can help make a diagnosis or rule out conditions such as cancer.
92	Disposable Hypodermic Needles	Insulin Needles/Pen Needles for insulin	Class B	Used to inject insulin for the treatment of diabetes.
93	Disposable Hypodermic Needles	Medication Injector	Class B	A subcutaneous injection is a method of administering medication.
94	Disposable Hypodermic Needles	Biopsy Needle Kit	Class B	A set of neurosurgical instruments designed to allow multiple biopsies from one or more targets in one trajectory
95	Disposable Hypodermic Needles	Angiographic Needle	Class B	Angiographic needle has a unique hub design with an ergonomic feel and a black triangle indicator to orient the bevel.
96	Disposable Hypodermic Needles	Mammary Biopsy Needle	Class B	The growth sample is suctioned out through a needle or cut out using a surgical procedure
97	Disposable Hypodermic Needles	Blood Collecting Needle	Class B	Intended to be used with evacuated blood collection tube for collection of venous blood.
98	Disposable Hypodermic Needles	Bone Marrow Needle	Class B	Needle inserted in Bone Marrow to collect sample
99	Disposable Hypodermic Needles	Gynaecological Cerclage Needle	Class B	It is a loop like instrument used to suture the cervix.
100	Disposable Hypodermic Needles	Cholangiography Needle	Class B	The aspirating needle is passed through the patient’s skin and liver tissue until the tippenetrates one of the hepatic ducts
101	Disposable Hypodermic Needles	Anaesthetic Conduction Needle	Class B	An anaesthesia conduction needle is a device used to inject local anaesthetics into a patient to provide regional anaesthesia
102	Disposable Hypodermic Needles	Emergency Airway Needle	Class B	Emergency airway puncture is the placement of a hollow needle through the throat into the airway. It is done to treat life-threatening choking.
103	Disposable Hypodermic Needles	Endoscopic Needle	Class B	Used to sample targeted submucosal gastrointestinal lesions through the accessory channel of an ultrasound endoscope.
104	Disposable Hypodermic Needles	Fistula Needle	Class B	To connect blood lines with the blood vessels through needles when dialysis is carried out
105	Disposable Hypodermic Needles	Epidural Needle	Class B	Intended for transient delivery of anasthetics to provide regional anesthesia or to facilitate placement of an epidural catheter
106	Disposable Hypodermic Needles	Gastro-Urology Needle	Class B	Intended for gastroenterology biopsy
107	Disposable Hypodermic Needles	Single Lumen Hypodermic Needle	Class B	A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.
108	Disposable Hypodermic Needles	Neurosurgical Suture Needle	Class B	A needle used in suturing during neurosurgical procedures or in the repair of nervous tissue.
109	Disposable Hypodermic Needles	Oocyte Aspiration Needle	Class B	Mission to collect the maximum amount of undamaged oocytes in a short time as possible.
110	Disposable Hypodermic Needles	Pneumoperitoneum Simple Needle	Class B	Inserting a Veress needle through the abdominal wall inside the peritoneal cavity.
111	Disposable Hypodermic Needles	Prefillable Glass Barrel with needle	Class B	Intended for the automatic self-administration of drugs and biologics from standard Glass Barrel.
112	Disposable Hypodermic Syringes	Aspiration Syringe	Class B	Used for either laparoscopic aspiration or injection
113	Disposable Hypodermic Syringes	Irrigating Syringes	Class B	cleaning debris away from the area the dentist is working on
114	Disposable Hypodermic Syringes	Insulin Syringes	Class B	Used to inject insulin for the treatment of diabetes.
115	Disposable Hypodermic Syringes	Auto Disable Syringe for single use	Class B	Intend to inject fluids into or withdraw fluids from the body.
116	Disposable Hypodermic Syringes	Traditional single use syringe without safety feature (Sterile hypodermic syringes for single use)	Class B	Intend to inject fluids into or withdraw fluids from the body.
117	Disposable Hypodermic Syringes	Auto-disable (AD) syringes for immunization	Class B	Intend to inject fluids into or withdraw fluids from the body.
118	Disposable Hypodermic Syringes	Re use Prevention (RUP) syringes for therapeutic injections (Syringes with re-use prevention feature)	Class B	Intend to inject fluids into or withdraw fluids from the body.
119	Disposable Hypodermic Syringes	Sharps Injury Protection (SIP) Plastic needle shield to be added to a syringe	Class B	Intend to inject fluids into or withdraw fluids from the body.
120	Disposable Perfusion Sets	Sharps Injury Blood Administration kits	Class B	It is used to administer blood from a container to a patient’s vascular system through a needle or catheter inserted into a vein
121	Disposable Perfusion Sets	Measured Volume IV Set	Class B	It is intended for use in the administration of fluids from a container into the patient’s vascular system through a vascular access device.
122	Disposable Perfusion Sets	Transfusion or Perfusion sets for single use	Class B	Transfusion Set is used to administer blood/drugs to a patient’s vascular system through a needle or catheter inserted into a vein.
123	Disposable Perfusion Sets	Manifolds	Class B	Indicated for fluid flow directional control and for providing access port/ports for administration of a solution.
124	Disposable Perfusion Sets	3 way stop cock as an accessory to perfusion sets	Class B	It is indicated for fluid flow directional control and for providing access port for administration of solution, withdrawal of fluid and pressure monitoring
125	Disposable Perfusion Sets	I V Flow regulator	Class B	An IV system and administration device offering precision care and consistent delivery.
126	Disposable Perfusion Sets	Extension Sets	Class B	Extension sets are sterile devices for single use only. They are intended to be used as part of a system for the infusion of fluids/medications in medical applications.
127	IV Cannulae	Intravenous Cannula	Class B	The IV Cannula is a passive device to provide for the infusion of fluids, drugs, and/or blood components, or to facilitate the placement of Vascular Access devices.
128	IV Cannulae	Arterial Cannula	Class B	Inserted into an artery, commonly the radial artery, and is used during major operations and in critical care areas to measure beat-to-beat blood pressure and to draw repeated blood samples.
129	IV Cannulae	Coronary Artery Cannula	Class B	Cannulation technique for left-sided coronary artery surgery.
130	IV Cannulae	Hemodialysis Cannula	Class B	Allowing the arterial blood to flow to the dialyzer and the dialyzed blood to return from the dialyzer to the circulation through the cannula in the vein.
131	IV Cannulae	Vena Cava Cannula	Class B	Inserted into Vena Cava, taking deoxygenated blood to heart.
132	IV Cannulae	Venous Cannula	Class B	It is intended for use as a single cannula for both venous drainage and reinfusion of blood via an internal jugular vein during extracorporeal life support procedures.
133	IV Cannulae	Ventricular Cannula	Class B	For use in neurosurgical procedures. It is specially designed to penetrate delicate brain tissue and give continued access to brain’s ventricular system.
134	IV Cannulae	Cannulact or Lymph Duct	Class B	A lymph duct is a great lymphatic vessel that empties lymph into one of the subclavian veins
135	Orthopaedic Implants	Intra Osseous Fixation Wire	Class B	Stabilization of fractured bony parts by direct fixation to one another with surgical wires
136	Orthopaedic Implants	Bone Wire	Class B	Intended to be used for bone stabilization in the hand and wrist.
137	Orthopaedic Implants	Bone cap	Class B	Intended to be implanted to cover the end of a bone.
138	Orthopaedic Implants	Plates, clipersScrews	Class B	rigid, limb brace, lumbar, lumbo-sacral, rib fracture, sacroiliac, thoracic oethosis.
139	Scalp Vein Set	Scalp Vein Set	Class B	Intended to be used for insertion into the patient’s vascular system (single use only) as an in-dwelling device to administer fluids intravenously or to sample blood.
140	Surgical Dressings	Surgical Staples	Class B	Surgical staples are specialized staples used in surgery in place of sutures to close skin wounds, connect or remove parts of body during surgery.
141	Surgical Dressings	Surgical Dressings	Class B	Dressing-gel, dressing- permeable, moisture dressing, tracheostomy tube dressing, wound and burn dressings, hydrogel dressing, wound and burn, occlusive.
142	Surgical Dressings	Cotton Grudges and bandages	Class B	Adhesive bandages, Gauge bandages, Pressure bandages, Traction bandages, Medical Absorbent (fiber) bandages.
143	Surgical Dressings	Sterile Drapes	Class B	It is intended for use during various surgeries.
144	Surgical Dressings	Casting tapes/Splint Rolls.	Class B	A prosthetic and orthotic accessory, intended for medical purposes to support, protect, or aid in the use of a cast, orthosis (brace), or prosthesis.
145	Surgical Dressings	Ligature Wire	Class B	offer a spot-welded auxiliary hook which may be added to any bracket by simply tying in the arch wire.
146	Surgical Dressings	Surgical Sealant	Class B	For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
147	Surgical Dressings	Wound Closure Device	Class B	Wound Closure Devices are indicated for soft tissue approximation.
148	Bone Marrow cell seperator		Class B	It is a general lab equipment to be used to isolate target cells and cells concentrate from bone and blood.
149	Blood Pressure Monitoring Devices		Class B	It is device used to measure the diastolic and systolic blood pressures.
150	Digital thermometer		Class B	It is device used to record the body temperature.
151	Catheters	trocar	Class B	A trocar is made up of an obturator (which may be a metal or plastic sharpened or non-bladed tip), a cannula(basically a hollow tube), and a seal. The trocar functions as a portal for the subsequent placement of other instruments, such as graspers, scissors, staplers, etc. It is also intended to remove air or fluid for the pleural space in a closed, one way fashion.

Class C Medical Device:

S.No	Notified Device Category/Drug	Device Name	Risk Class	General Intended Use
1	CT scan		Class C	Use of x-ray source and digitally scanned computer technology to create cross-sectional images of the body
2	MRI Equipment		Class C	It is a medical imaging procedure using radio waves, magnetic fields, and magnetic field gradients to generate images of organs in the body
3	Defibrillators		Class C	It is a device that automatically analyzes the rhythm of heart of cardiac arrest patients and delivers an electrical shock to the heart for restoring the normal rhythm of heart.
4	PET		Class C	Intended to detect the gamma radiation and positron emitting radionuclides in the body and produce cross-sectional images which reflect the distribution in the body or individual organs.
5	X-ray Machine		Class C	Use of X-rays to diagnose or treat patients by imaging the internal structure of the body to assess the abnormalities in the body.
6	Nebulizer		Class C	It is device used to administer medications in the form of mist to inhale for respiratory disorders.
7	Organ preservatiove solution		Class C	Solution for hypothermic flushing, storage and transport of organs and to maintain the organ vitality during transplant into human recipients.
8	Dialysis Machine		Class C	It is used for acute or chronic kidney failure that filters blood to remove excess water and waste products.
9	Ablation Device	Thermal Ablation Device	Class C	Destruction of tissue by application of heat. Ablation of the endometrium as a treatment for menorrhagia is performed by placing a balloon filled with hot water in the uterine cavity.
10	Ablation Device	Uterine balloon therapy devices	Class C	System is a closed-cycle cryosurgical device intended to ablate the endometrial lining of the uterus in premenopausal women with menorrhagia (excessive bleeding) due to benign causes for whom childbearing is complete.
11	Ablation Device	RF Conducte MR steerable electrode catheter	Class C	It is intended for intracardiac ablation
12	Bone Cements	Bone cement	Class C	Intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.
13	Cardiac Stents	Bifurcation Stent	Class C	Intended for improving the side branch luminal diameter of arterial bifurcation liaisons.
14	Catheters	Transabdominal (Fetoscope) Aminoscope and Accessories	Class C	It is a device designed to permit direct visual examination of the foetus by a telescopic system via abdominal entry. The device is used to ascertain foetal abnormalities
15	Catheters	Anaesthetic Conduction Kit	Class C	An anaesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anaesthesia. The device may contain syringes, needles, and drugs.
16	Catheters	Vena Cava Filter Sets	Class C	It is indicated for the prevention of recurrent pulmonary embolism via placement in the vena cava to treat various disease conditions.
17	Catheters	Anesthesia conduction filter	Class C	A microporous filter used while administering to a patient injections of local anesthetics to minimize particulate (foreign material) contamination of the injected fluid
18	Catheters	Central Venous Catheters	Class C	It is indicated for use in patients requiring administration of solutions, blood sampling, central venous pressure monitoring and injection of contrast media.
19	Catheters	Introducer Sheath	Class C	Intended to provide easier access to the femoral, popliteal and infrapopliteal arteries.
20	Catheters	Carotid Filter System	Class C	Used while performing angioplasty and stenting procedures in carotid arteries.
21	Catheters	RETRIEVAL SNARE	Class C	intended for use in the retrieval and manipulation of atraumatic foreign bodies located in the coronary and peripheral cardiovascular system and the extra-cranial neurovascular anatomy.
22	Catheters	Hemodialysis Catheter (Long Term )	Class C	A dialysis catheter is a catheter used for exchanging blood to and from the hemodialysis machine from the patient. The dialysis catheter contains two lumens: Venous. Arterial
23	Catheters	Percuataneous Intravascular Long Term Catheter	Class C	The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids,medications, and nutrients; the sampling of blood;
24	Catheters	Percutaneous Long Term Intraspinal Catheter	Class C	To conduct a preimplantintra spinal infusion screening trial procedure prior to implanting a pump
25	Catheters	Implanted Subcutaneous Intravascular Portn& Catheter	Class C	The device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood
26	Catheters	Subcutaneous Intraspinal Port & Catheter	Class C	Catheters used for both epidural Intrathecal infusion include short-term externalized catheters and long-term catheters that are tunnelled in the subcutaneous tissue
27	Catheters	Peripheral, Transluminal Angioplasty Catheter	Class C	A catheter for treating peripheral vascular diseases
28	Catheters	Coronary Dilation Catheter	Class C	It is intended for balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion.
29	Catheters	Diagnostic Radiology Catheters	Class C	Angiography catheters are designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures.
30	Catheters	Ventrricular Catheter	Class C	It is used to monitor pressure in patients with brain injuries, intracranial bleeds or other brain abnormalities that lead to increased fluid build-up.
31	Catheters	Balloon Repair Kit Catheter	Class C	A device used to repair or replace the balloon of a balloon catheter. The kit contains the materials, such as glue and balloons, necessary to affect the repair or replacement.
32	Catheters	Micro-catheter	Class C	It is intended to access the peripheral and neurovasculature for the controlled selective infusion of physician specified therapeutic agents such as embolization materials and or diagnostic materials such as contrast media
33	Catheters	Imaging Catheter	Class C	Intended for use with the various medical imaging consoles.
34	Catheters	Tympanostomy Tube	Class C	It is a small tube inserted into the eardrum in order to keep the middle ear aerated for a prolonged period of time, and to prevent the accumulation of fluid in the middle ear
35	Catheters	Anastomosis Bypass Tube	Class C	It is anchored to mucosa and submucosa 3 centimetres proximal to a site of colocolonic anastomosis and later spontaneously evacuated by way of the rectum.
36	Catheters	Wire	Class C	An esophageal stent is a stent (tube) placed in the oesophagus to keep a blocked area open so the patient can swallow soft food and liquids
37	Catheters	Biliary stents	Class C	the duodenum in conditions such as ascending cholangitis due to obstructing gallstones
38	Catheters	Duodenal stents	Class C	Duodenal Stent is indicated for the palliative treatment of gastroduodenal obstructions
39	Catheters	Colonic stent	Class C	A colonic stent is a flexible, hollow tube designed to keep a segment of the colon (large bowel) open when it has become blocked(obstructed). This blockage is commonly caused by a tumour inside the bowel or by outside pressure on the bowel wall.
40	Catheters	Pancreatic stent	Class C	Pancreatic duct stents are often placed in patients who have chronic pancreatitis
41	Catheters	Peripheral Stent System	Class C	A Peripheral stent is a tube-shaped device placed in the peripheralarteries that supply blood into body organ.
42	Contraceptives	Tubal Rings/Fallopian Rings	Class C	Contraception devices for female sterilization
43	Contraceptives	Male / Female Condoms	Class C	Condom with nonoxynol-9, micro- condom, prophylactic (condom) – latex sheath, non-latex, condoms with natural membrane, intra vaginal condoms etc.
44	Disposable Hypodermic Syringes	Injector Type actuator syringe	Class C	A syringe actuator for an injector is an electrical device that controls the timing of an injection by an angiographic or indicator injector and synchronizes the injection with the electrocardiograph signal.
45	Disposable Perfusion Sets	Custom Perfusion System	Class C	Indicated for use in the extra corporeal circuit during cardio pulmonary bypass surgery procedure.
46	Disposable Perfusion Sets	Infusion Pump or Elastomeric Infusion Device	Class C	The Infusion Pumps intended for slow, continuous delivery through clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), and subcutaneous or epidural infusion of medications directly into an intra-operative site or subcutaneously for post operative pain management.
47	Internal Prosthetic eplacements	Tissue Expanders	Class C	Intended to be used in breast reconstruction or treatment of soft tissue deformities such as used following mastectomy or for treatment of underdeveloped breasts.
48	Internal Prosthetic eplacements	Bio Patches	Class C	Intended for reconstruction and repair of defects of pericardium.
49	Internal Prosthetic eplacements	Voice / laryngeal Prothesis	Class C	The device is intended to direct pulmonary air flow to the pharynx in the absence of the larynx, for permitting esophageal speech.
50	Internal Prosthetic eplacements	Hearing Prosthesis System	Class C	The prostheses are intended for partial ossicular replacement to restore functionality to the middle ear.
51	Internal Prosthetic eplacements	Annuloplasty ring	Class C	An annuloplasty ring implanted around the mitral or tricuspid heart valve for reconstructive treatment.
52	Internal Prosthetic eplacements	Ear, nose, and throat and facial synthetic polymer material or implant	Class C	It is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck.
53	Internal Prosthetic eplacements	Mandibular implant facial prosthesis	Class C	Intended to be implanted for use in the functional reconstruction of mandibular deficits.
54	Internal Prosthetic eplacements	Sacculotomy tack (Cody tack)	Class C	Intended to be implanted to relieve the symptoms of vertigo.
55	Internal Prosthetic eplacements	Endolymphatic shunt	Class C	Intended to be implanted to relieve the symptoms of vertigo.
56	Internal Prosthetic eplacements	An endolymphatic shunt tube with valve	Class C	It is a device that consists of a pressure-limiting valve associated with a tube intended to be implanted in the inner ear to relieve symptoms of vertigo and hearing loss.
57	Internal Prosthetic eplacements	Fallopian tube prosthesis	Class C	A device designed to maintain the patency (openness) of the fallopian tube and is used after reconstructive surgery.
58	Internal Prosthetic eplacements	Vaginal stent	Class C	A device used to enlarge the vagina by stretching, or to support the vagina and to hold a skin graft after reconstructive surgery.
59	Internal Prosthetic eplacements	Intramedullary fixation rod	Class C	Intended to be implanted into the medullary (bone marrow) canal of long bones for the fixation of fractures.
60	Internal Prosthetic eplacements	Endosseous dental implant	Class C	Intended to be surgically placed in the bone of jaw arches to provide support for prosthetic devices, such as artificial teeth.
61	Internal Prosthetic eplacements	Dental implant	Class C	A dental implant is a surgical component that interfaces with thebone of the jaw or skull to support a dental prosthesis such as crown, bridge, denture, facial prosthesis or to act as an orthodontic anchor.
62	Internal Prosthetic eplacements	Bone grafting material	Class C	Intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.
63	Internal Prosthetic eplacements	Penile rigidity implant	Class C	A device that is implanted in the corpora cavernosa of the penis to provide rigidity. It is intended to be used in men diagnosed as having erectile dysfunction
64	Internal Prosthetic eplacements	Artificial Urinary Sphincters implants	Class C	It is used to prevent incontinence by occluding the urethra.
65	Internal Prosthetic eplacements	Implanted mechanical/hydrau lic urinary continence device	Class C	An implanted mechanical/hydraulic urinary continence device is a device used to treat urinary incontinence by the application of continuous or intermittent pressure to occlude the urethra.
66	Internal Prosthetic eplacements	Breast implant	Class C	Breast implant is used to increase the breast size.
67	Internal Prosthetic eplacements	Tracheal prosthesis	Class C	It is intended to be implanted to restore the structure and/or function of the trachea or trachealbronchial tree
68	Internal Prosthetic eplacements	Polymeric Surgical Mesh	Class C	The polymeric mesh comprises an absorbable polymeric fibre and a non-absorbable polymeric fibre knitted together to form an interdependent, co-knit mesh structure.
69	Internal Prosthetic eplacements	Endosseous dental implant abutment	Class C	Intended for use as an aid in prosthetic rehabilitation.
70	Intra Ocular Lenses	Intraocular lens	Class C	Intraocular lens (IOL) are lens implanted in the eye used to treat cataracts or myopia
71	IV Cannulae	A-V Shunt Cannula	Class C	It is inserted into one of the client’s blood vessels to facilitator repeated hemodialysis.
72	Orthopaedic Implants	Cortical Fixation Implant / rigidloop Adjustable Cortical Fixation System	Class C	Cortical Fixation System is a machined titanium implant designed to provide fixation in the repair of tendons and ligaments.
73	Orthopaedic Implants	Intervertebral Body Fusion Device / Fuse Spinal System	Class C	It is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease (“DDD”) at one or two contiguous spinal levels.
74	Orthopaedic Implants	Orthopedic implant & accessories	Class C	Intended to replace a missing joint or bone or to support a damaged bone.
75	Orthopaedic Implants	Pedicle screw spinal system	Class C	It is used to intended to provide immobilization and stabilization of spinal segments
76	Orthopaedic Implants	Ankle joint metal/composite semi-constrained cemented prosthesis	Class C	An ankle joint metal/composite semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle joint.
77	Orthopaedic Implants	Ankle joint metal/polymer non-constrained cemented prosthesis	Class C	A device intended to be implanted to replace an ankle joint. The device limits minimally translation in one or more planes. It has no linkage across- the-joint.
78	Orthopaedic Implants	Elbow joint metal/polymer constrained cemented prosthesis	Class C	An elbow joint metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace an elbow joint.
79	Orthopaedic Implants	Elbow joint metal/polymer semi-constrained cemented prosthesis	Class C	An elbow joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an elbow joint
80	Orthopaedic Implants	elbow joint radial (hemi-elbow) polymer	Class C	An elbow joint radial (hemi-elbow) polymer prosthesis is a device intended to be implanted made of medical grade silicone elastomer used to replace the proximal end of the radius.
81	Orthopaedic Implants	Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis	Class C	A device intended to be implanted made of alloys, such as cobalt-chromium-molybdenum, that is used to replace the distal end of the humerus formed by the trochlea humeri and the capitulumhumeri.
82	Orthopaedic Implants	elbow joint humeral (hemi-elbow) metallic uncemented prosthesis	Class C	A device intended to be implanted made of alloys, such as cobalt-chromium-molybdenum, that is used to replace the distal end of the humerus formed by the trochlea humeri and the capitulumhumeri.
83	Orthopaedic Implants	Finger joint metal/metal constrained uncemented prosthesis.	Class C	A device intended to be implanted to replace a metacarpophalangeal or proximal interphalangeal (finger) joint.
84	Orthopaedic Implants	Finger joint metal/metal constrained cemented prosthesis.	Class C	A finger joint metal/metal constrained cemented prosthesis is a device intended to be implanted to replace a metacarpophalangeal (finger) joint.
85	Orthopaedic Implants	Finger joint polymer constrained prosthesis	Class C	A device intended to be implanted to replace a metacarpophalangeal or proximal interphalangeal (finger) joint
86	Orthopaedic Implants	hip joint metal/composite semi-constrained cemented prosthesis	Class C	A hip joint metal/composite semi-constrained cemented prosthesis is a two-part device intended to be implanted to replace a hip joint.
87	Orthopaedic Implants	Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis	Class C	Intended to be implanted to replace a hip joint
88	Orthopaedic Implants	Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.	Class C	Intended to be implanted to replace a hip joint
89	Orthopaedic Implants	A knee joint femorotibial metallic constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint	Class C	Intended to be implanted to replace part of a knee joint
90	Orthopaedic Implants	Shoulder joint metal/metal or metal/polymer constrained cemented prosthesis	Class C	Intended to be implanted to replace a shoulder joint
91	Orthopaedic Implants	Wrist joint carpal lunate polymer prosthesis	Class C	Intended to be implanted to replace the carpal lunate bone of the wrist.
92	Orthopaedic Implants	Wrist joint metal/polymer semi-constrained cemented prosthesis	Class C	Intended to be implanted to replace a wrist joint.
93	Orthopaedic Implants	Wrist joint metal constrained cemented prosthesis.	Class C	Intended to be implanted to replace a wrist joint.
94	Orthopaedic Implants	Wrist joint polymer constrained prosthesis	Class C	Intended to be implanted to replace a wrist joint
95	Orthopaedic Implants	Wrist joint carpal trapezium polymer prosthesis.	Class C	Intended to be implanted to replace the carpal trapezium bone of the wrist.
96	Orthopaedic Implants	Wrist joint carpal scaphoid polymer prosthesis.	Class C	Intended to be implanted to replace the carpal scaphoid bone of the wrist.
97	Orthopaedic Implants	Toe joint phalangeal (hemi-toe) polymer prosthesis.	Class C	Intended to be implanted to replace the base of the proximal phalanx of the toe.
98	Orthopaedic Implants	Toe joint polymer constrained prosthesis	Class C	Intended to be implanted to replace the first metatarsophalangeal (big toe) joint.
99	Orthopaedic Implants	Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.	Class C	A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
100	Orthopaedic Implants	Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.	Class C	A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
101	Orthopaedic Implants	Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis	Class C	It is intended to be implanted to replace part of a shoulder joint
102	Orthopaedic Implants	Shoulder joint metal/polymer/metal nonconstrained or semi- constrained porous-coated uncemented prosthesis	Class C	It is a device intended to be implanted to replace a shoulder joint.
103	Orthopaedic Implants	Shoulder joint metal/polymer semi-constrained cemented prosthesis	Class C	Intended to be implanted to replace a shoulder joint
104	Orthopaedic Implants	shoulder joint metal/polymer non-constrained cemented prosthesis.	Class C	Intended to be implanted to replace a shoulder joint.
105	Orthopaedic Implants	Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis.	Class C	Intended to be implanted to replace part of a knee joint.
106	Orthopaedic Implants	Knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis.	Class C	Intended to be implanted to replace the retropatellar articular surface of the patellofemoral joint .
107	Orthopaedic Implants	knee joint femoral (hemi-knee) metallic uncemented prosthesis	Class C	Intended to be implanted to replace part of a knee joint.
108	Orthopaedic Implants	knee joint patellofemorotibial metal/polymer.	Class C	Intended to be implanted to replace a knee joint.
109	Orthopaedic Implants	Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.	Class C	Intended to be implanted to replace a knee joint
110	Orthopaedic Implants	Knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis	Class C	Intended to be implanted to replace a knee join
111	Orthopaedic Implants	knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis	Class C	It is intended to be implanted to replace part of a knee joint in the treatment of primary patellofemoral arthritis or chondromalacia.
112	Orthopaedic Implants	Knee joint femorotibial (uni-compartmental) metal/polymer porous-coated uncemented prosthesis.	Class C	Intended to be implanted to replace part of a knee joint.
113	Orthopaedic Implants	Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.	Class C	Intended to be implanted to replace part of a knee joint.
114	Orthopaedic Implants	Knee joint femorotibial metal/polymer non-constrained cemented prosthesis	Class C	Intended to be implanted to replace part of a knee joint.
115	Orthopaedic Implants	Knee joint femorotibial metal/polymer constrained cemented prosthesis.	Class C	Knee joint femorotibial metal/polymer constrained cemented prosthesis.
116	Orthopaedic Implants	Knee joint femorotibial metal/polymer constrained cemented prosthesis.	Class C	Intended to be implanted to replace part of a knee joint.
117	Orthopaedic Implants	Knee joint femorotibial metal/composite semi-constrained cemented prosthesis.	Class C	Intended to be implanted to replace part of a knee joint.
118	Orthopaedic Implants	Knee joint femorotibial metal/composite non-constrained cemented prosthesis.	Class C	Intended to be implanted to replace part of a knee joint.
119	Orthopaedic Implants	Hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis.	Class C	Intended to be implanted to replace the articulating surfaces of the hip while preserving the femoral head and neck
120	Orthopaedic Implants	Spinal intervertebral body fixation orthosis	Class C	The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.
121	Orthopaedic Implants	Spinal interlaminal fixation orthosis	Class C	A device intended to be implanted made of an alloy, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is used primarily in the treatment of scoliosis.
122	Orthopaedic Implants	Resorbable calcium salt bone void filler device	Class C	A resorbable calcium saltbone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis
123	Orthopaedic Implants	Smooth or threaded metallic bone fixation fastener	Class C	It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
124	Orthopaedic Implants	Sacroiliac joint fixation	Class C	The sacroiliac joints fixation may serve as protective mechanism for the lumbosacral region.
125	Surgical Dressings	Wound Dressings/Bacterio static Wound Dressings	Class C	Includes Beads, Hydrophilics For Wound Exudate Absorption for wound care.
126	Surgical Dressings	Haemostatic Gelatine Sponge /Haemostat	Class C	Intended for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes
127	Surgical Dressings	Surgical Dressings	Class C	An absorbable haemostatic agent or dressing is a device intended to produce haemostasis by accelerating the clotting process of blood. It is absorbable.
128	Surgical Dressings	Suture Non Absorable Synthetic.	Class C	Non-absorbable suture is comprised of surgical steel as well as synthetic non- absorbable sutures for use in general soft tissue approximation and ligation.
129	Surgical Dressings	Suture Absorable	Class C	The device is intended for use in general soft tissue approximation and ligation.
130	Surgical Dressings	Endovascular suturing system	Class C	It is a medical device intended to provide fixation and sealing between an endovascular graft and the native artery.
131	Surgical Dressings	Fixation, non-absorbable for pelvic use.	Class C	Attaching suture or stapling ligaments of the pelvic floor.
132	Surgical Dressings	Tissue adhesive for the topical use	Class C	Intended for topical closure of surgical incisions including laparoscopic incisions and simple traumatic lacerations.

Class D Medical Devices:

S.No	Notified Device Category/Drug	Device Name	Risk Class	General Intended Use
1	Ablation Device	Radiofrequency Ablation Device	Class D	A medical procedure in which part of the electrical conduction system of the heart, tumour or other dysfunctional tissue is ablated using the heat generated from high frequency alternating current
2	Ablation Device	Percutaneous Conduction Tissue Ablation	Class D	Clinical applications using hollow needles (cryoprobes) through which cooled, thermally conductive, fluids are circulated.
3	Ablation Device	Suction Ablation Catheter System	Class D	Intended for use in inactivating portions of the heart’s conduction system to prevent abnormal heartbeat rates, comprises a tubular body having an open, distal end and a proximal aperture for applying suction through the catheter and through the distal end.
4	Cardiac Stents	Coronary stent	Class D	A coronary stent is a tube-shaped device placed in the coronary arteries that supply blood to the heart, to keep the arteries open in the treatment of coronary heart disease.
5	Cardiac Stents	Bioresorbable Vascular Scaffold (BVS) System	Class D	An absorbable stent which is placed into a blood vessel (coronary artery) during angioplasty to help keep the coronary artery open.
6	Catheters	Angiographic Guide Wire	Class D	It delivers radio opaque media and therapeutic agents to selected sites in the vascular system. It is also used to lead a guide wire or a catheter into the target site.
7	Catheters	Cardiac Catherization Kit	Class D	Cardiac catheterization is a general term for a group of procedures that are performed using this method, such as coronary angiography and left ventricle angiography
8	Catheters	Balloon for Cerebrovascular Occlusion	Class D	Balloon used to treat Blockage closing of Cerebrovascular vessels/carotid arteries
9	Catheters	Intra-Aortic System Balloon and Control	Class D	It is a mechanical device that increases myocardial oxygen perfusion while at the same time increasing cardiac output
10	Catheters	Embolic Filter system	Class D	It is indicated for general use as a guidewire and embolic protection system during angioplasty and stenting procedures in carotid arteries with reference vessel diameters of 2.5 to 5.5mm.
11	Catheters	RETRIEVAL SNARE	Class D	intended for use in the retrieval and manipulation of atraumatic foreign bodies located in the coronary and peripheral system and the extra cranial neurovascular anatomy.
12	Catheters	Cardiac Thermodilution Catheter	Class D	A catheter used in thermodilution for in troduction of the cold liquid indicator into thecardiovascular system or for the assessment of a patient’s hemodynamic condition through simultaneous right atrial, right ventricular, and pulmonary artery or wedge pressure monitoring, cardiac output determination, and for infusing solutions.
13	Catheters	Cardiovascular Catheter	Class D	A thin, hollow tube called a catheter is inserted into a large blood vessel that leads to heart.
14	Catheters	Cerebrospinal Catheter	Class D	For treatment or prevention of cranial/spinal cerebrospinal fluid fistula.
15	Catheters	Atherectomy Coronary Catheter	Class D	A catheter containing a rotating cutter and a collecting chamber for debris, used for atherectomy and endarterectomy.
16	Catheters	Electrode Recording Probe, Electrode Recording Catheter	Class D	A cardiac catheter containing one or more electrodes; it may be used to pace the heart or to deliver high energy shocks.
17	Catheters	Embolectomy Catheter	Class D	indicated for the removal of fresh, soft emboli and
18	Catheters	Intraaortic Balloon Catheter	Class D	It is indicated for use in patients undergoing cardiopulmonary bypass.
19	Catheters	Intracardiac Mapping, High Density Array Catheter	Class D	A high density array catheter once used in the right atrium to map and diagnosis complexarrhythmias and assess the effectiveness of ablation treatment.
20	Catheters	Intravascular Occluding Catheter	Class D	It is a catheter with an inflatable or detachable balloon tip that is used to block a blood vessel to treat malformations, e.g., aneurysms of intracranial blood vessels
21	Catheters	Intravascular Diagnostic Catheter	Class D	Used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels
22	Catheters	Occlusion Catheter	Class D	Insertion of a device or develop at any time during the course of intravenous (IV) therapy.
23	Catheters	Percutaneous Catheter	Class D	A needle catheter getting access to a blood vessel, followed by the introduction of a wire through the lumen (pathway) of the needle.
24	Catheters	Perfusion Catheter	Class D	Perfusion catheter allowing localised perfusion of drugs not only into the vessel lumen, but also directly into the vessel wall at low pressure, during coronary intervention.
25	Catheters	Pericardium Drainage Catheter	Class D	Catheter drainage of the pericardium
26	Catheters	Atherectomy Peripheral Catheter	Class D	Intended for use in atherectomy of the peripheral vasculature.
27	Catheters	Septostomy Catheter	Class D	Used to enlarge interatrial openings
28	Catheters	Thrombectomy Catheter	Class D	Thrombectomy catheter is specifically designed to treat deep vein thrombosis (DVT) in large-diameter upper and lower peripheral veins.
29	Catheters	Transluminal, Coronary Angioplasty, Percutaneous Catheter	Class D	The catheter is placed in the opening or ostium of one the coronary arteries
30	Catheters	Central Nervous System Shunt including Neurological catheters and other Components	Class D	It is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume.
31	Catheters	Intra-aortic balloon and control system	Class D	It is a medical device which is placed in the aorta to improve cardiovascular functioningduringcertain life-threatening emergencies.
32	Catheters	Ventricular bypass (assistive)	Class D	A ventricular bypass (assistive) device is a device that assists the left or right ventricle in maintaining circulatory blood flow.
33	Catheters	Catheter Guide Wire	Class D	It is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The PTCA Guide Wires are not to be used in the cerebral blood vessel
34	Catheters	Catheter Guide	Class D	It is intended to facilitate the placement of balloon ilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). PTCA Guide Wires are not to be used in the cerebral blood vessel.
35	Catheters	Carotid Stent System	Class D	Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization.
36	Contraceptives	Cu-T	Class D	Indicated for intrauterine contraception for up to 10 years.
37	Drug Eluting Stents	Drug eluting stent	Class D	Stent, coronary, drug-eluting – a metal scaffold with a drug coating placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen. The drug coating is intended to inhibit restenosis.
38	Heart Valves	Heart valve	Class D	A device intended to perform the function of any of the heart’s natural valves.
39	Internal Prosthetic eplacements	Vascular graft/occluders/Car diac Patches	Class D	Intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access.
40	Internal Prosthetic eplacements	Vascular embolization device	Class D	It is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors.
41	Internal Prosthetic eplacements	Cardiovascular prosthetic devices	Class D	An intra-cardiac patch or pledgete which is a medical device placed in the heart and is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.
42	Internal Prosthetic eplacements	Total ossicular replacement prosthesis	Class D	It is a device intended to be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear.
43	Internal Prosthetic eplacements	Eye sphere implant	Class D	An eye sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball with the sclera left intact.
44	Internal Prosthetic eplacements	Keratoprosthesis	Class D	It is a device intended to provide a transparent optical pathway through an opacified cornea, either intraoperatively or permanently, in an eye.
45	Internal Prosthetic eplacements	Bone heterograft	Class D	Intended to be implanted that is made from bovine bones and used to replace human bone following surgery in the cervical region of the spinal column.
46	Internal Prosthetic eplacements	Total temporomandibular joint prosthesis	Class D	Intended to be implanted in the human jaw to replace the mandibular condyle and augment the glenoid fossa to functionally reconstruct the temporomandibular joint.
47	Internal Prosthetic eplacements	Glenoid fossa prosthesis	Class D	Intended to be implanted in the temporomandibular joint to augment a glenoid fossa or to provide an articulation surface for the head of a mandibular condyle.
48	Internal Prosthetic eplacements	Mandibular condyle prosthesis	Class D	Intended to be implanted in the human jaw to replace the mandibular condyle and to articulate within a glenoid fossa.
49	Internal Prosthetic eplacements	An interarticular disc prosthesis	Class D	Intended to be an interface between the natural articulating surface of the mandibular condyle and glenoid fossa.
50	Internal Prosthetic eplacements	Penile inflatable implant	Class D	A penile inflatable implant is a device which is implanted in the penis, connected to a reservoir filled with radiopaque fluid implanted in the abdomen, and a subcutaneous manual pump implanted in the scrotum. This device is used in the treatment of erectile impotence.
51	Internal Prosthetic eplacements	Cochlear implant	Class D	A cochlear implant is an implanted electronic hearing device, designed to produce useful hearing sensations to a person with severe to profound nerve deafness by electrically stimulating nerves inside the inner ear.
52	Internal Prosthetic eplacements	Retinal implant	Class D	The retinal implant is meant to partially restore useful vision to people who have lost their vision due to degenerative eye conditions
53	Internal Prosthetic eplacements	Intended	Class D	A testicular prosthesis is an implanted device that consists of a solid or gel-filled silicone rubber prosthesis that is implanted surgically to resemble a testicle.
54	Internal Prosthetic eplacements	Aneurysm Implant (detachable coils/clips)	Class D	It is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.
55	Orthopaedic Implants	Intervertebral body fusion device	Class D	The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion
56	Orthopaedic Implants	hip joint metal constrained cemented or uncemented prosthesis	Class D	A hip joint metal constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint
57	Orthopaedic Implants	Hip joint metal/polymer constrained cemented or uncemented prosthesis	Class D	A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint.
58	Orthopaedic Implants	Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis.	Class D	It is a prosthesis intended to be implanted to replace a hip joint
59	Orthopaedic Implants	hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis	Class D	Intended to be implanted to replace a hip joint.
60	Orthopaedic Implants	Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis	Class D	Intended to be implanted to replace a hip joint.
61	Orthopaedic Implants	hip joint metal constrained cemented or uncemented prosthesis	Class D	Intended to be implanted to replace a hip joint
62	Orthopaedic Implants	Hip joint metal/polymer constrained cemented or uncemented prosthesis.	Class D	Intended to be implanted to replace a hip joint
63	Orthopaedic Implants	Hip joint femoral (hemi-hip) metallic resurfacing prosthesis	Class D	Intended to be implanted to replace a portion of the hip joint.
64	Orthopaedic Implants	A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis	Class D	Intended to be implanted to replace the head and neck of the femur
65	Orthopaedic Implants	A hip joint femoral (hemi-hip) trunnion bearing metal/polyacetal cemented prosthesis	Class D	Intended to be implanted to replace the head and neck of the femur
66	Orthopaedic Implants	Hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis.	Class D	Intended to be implanted to replace the head and neck of the femur.
67	Orthopaedic Implants	A hip joint (hemi-hip) acetabular metal cemented prosthesis.	Class D	Intended to be implanted to replace a portion of the hip joint.
68	Orthopaedic Implants	Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.	Class D	Intended to be implanted to replace a portion of the hip joint.
69	Orthopaedic Implants	Cervical Artificial Disc	Class D	Cervical Artificial Disc is indicated for reconstruction of the disc.
70	Surgical Dressings	Absorable Hemostatic Based.	Class D	An absorbable haemostatic agent or dressing is a device intended to produce haemostasis by accelerating the clotting process of blood. It is absorbable.
71	Surgical Dressings	Tissue adhesive for non-topical use	Class D	Intended for use in adhesion of internal tissues and vessels, for example; adhesives used in the embolization of brain arteriovenous malformation for use in ophthalmic surgery.
72	Surgical Dressings	Intracardiac patch	Class D	intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.
73	Internal prosthetic replacement	Voice / laryngeal Prothesis	Class D	The device is intended to direct pulmonary air flow to the pharynx in the absence of the larynx, for permitting esophageal speech.
74	Internal Prosthetic Replacements	Breast implant	Class D	Breast implant is used to increase the breast size.