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 29th 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. |
Class C Medical Device:
S.No | Notified Device Category/Drug | Device Name | Risk Class | General Intended Use |
1 | Ablation Device | Vein Ablation Device | Class C | It is a non-thermal, minimally-invasive choice for treating the source of varicose veins, providing patients with immediate recovery and a return to normal daily routines |
2 | 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. |
3 | 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. |
4 | Ablation Device | RF Conducte MR steerable electrode catheter | Class C | It is intended for intracardiac ablation |
5 | 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. |
6 | Cardiac Stents | Bifurcation Stent | Class C | Intended for improving the side branch luminal diameter of arterial bifurcation liaisons. |
7 | 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 |
8 | 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. |
9 | 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. |
10 | 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 |
11 | 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. |
12 | Catheters | Introducer Sheath | Class C | Intended to provide easier access to the femoral, popliteal and infrapopliteal arteries. |
13 | Catheters | Carotid Filter System | Class C | Used while performing angioplasty and stenting procedures in carotid arteries. |
14 | 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. |
15 | 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 |
16 | 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; |
17 | Catheters | Percutaneous Long Term Intraspinal Catheter | Class C | To conduct a preimplantintra spinal infusion screening trial procedure prior to implanting a pump |
18 | 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 |
19 | 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 |
20 | Catheters | Peripheral, Transluminal Angioplasty Catheter | Class C | A catheter for treating peripheral vascular diseases |
21 | 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. |
22 | 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. |
23 | 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. |
24 | 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. |
25 | 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 |
26 | Catheters | Imaging Catheter | Class C | Intended for use with the various medical imaging consoles. |
27 | 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 |
28 | 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. |
29 | 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 |
30 | Catheters | Biliary stents | Class C | the duodenum in conditions such as ascending cholangitis due to obstructing gallstones |
31 | Catheters | Duodenal stents | Class C | Duodenal Stent is indicated for the palliative treatment of gastroduodenal obstructions |
32 | 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. |
33 | Catheters | Pancreatic stent | Class C | Pancreatic duct stents are often placed in patients who have chronic pancreatitis |
34 | Catheters | Peripheral Stent System | Class C | A Peripheral stent is a tube-shaped device placed in the peripheralarteries that supply blood into body organ. |
35 | Contraceptives | Tubal Rings/Fallopian Rings | Class C | Contraception devices for female sterilization |
36 | 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. |
37 | 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. |
38 | Disposable Perfusion Sets | Custom Perfusion System | Class C | Indicated for use in the extra corporeal circuit during cardio pulmonary bypass surgery procedure. |
39 | 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. |
40 | 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. |
41 | Internal Prosthetic eplacements | Bio Patches | Class C | Intended for reconstruction and repair of defects of pericardium. |
42 | 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. |
43 | Internal Prosthetic eplacements | Hearing Prosthesis System | Class C | The prostheses are intended for partial ossicular replacement to restore functionality to the middle ear. |
44 | Internal Prosthetic eplacements | Annuloplasty ring | Class C | An annuloplasty ring implanted around the mitral or tricuspid heart valve for reconstructive treatment. |
45 | 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. |
46 | Internal Prosthetic eplacements | Mandibular implant facial prosthesis | Class C | Intended to be implanted for use in the functional reconstruction of mandibular deficits. |
47 | Internal Prosthetic eplacements | Sacculotomy tack (Cody tack) | Class C | Intended to be implanted to relieve the symptoms of vertigo. |
48 | Internal Prosthetic eplacements | Endolymphatic shunt | Class C | Intended to be implanted to relieve the symptoms of vertigo. |
49 | 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. |
50 | 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. |
51 | 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. |
52 | 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. |
53 | 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. |
54 | 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. |
55 | Internal Prosthetic eplacements | Bone grafting material | Class C | Intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. |
56 | 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 |
57 | Internal Prosthetic eplacements | Artificial Urinary Sphincters implants | Class C | It is used to prevent incontinence by occluding the urethra. |
58 | 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. |
59 | Internal Prosthetic eplacements | Breast implant | Class C | Breast implant is used to increase the breast size. |
60 | 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 |
61 | 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. |
62 | Internal Prosthetic eplacements | Endosseous dental implant abutment | Class C | Intended for use as an aid in prosthetic rehabilitation. |
63 | Intra Ocular Lenses | Intraocular lens | Class C | Intraocular lens (IOL) are lens implanted in the eye used to treat cataracts or myopia |
64 | IV Cannulae | A-V Shunt Cannula | Class C | It is inserted into one of the client’s blood vessels to facilitator repeated hemodialysis. |
65 | 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. |
66 | 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. |
67 | Orthopaedic Implants | Orthopedic implant & accessories | Class C | Intended to replace a missing joint or bone or to support a damaged bone. |
68 | Orthopaedic Implants | Pedicle screw spinal system | Class C | It is used to intended to provide immobilization and stabilization of spinal segments |
69 | 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. |
70 | 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. |
71 | 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. |
72 | 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 |
73 | 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. |
74 | 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. |
75 | 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. |
76 | 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. |
77 | 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. |
78 | Orthopaedic Implants | Finger joint polymer constrained prosthesis | Class C | A device intended to be implanted to replace a metacarpophalangeal or proximal interphalangeal (finger) joint |
79 | 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. |
80 | 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 |
81 | Orthopaedic Implants | Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis. | Class C | Intended to be implanted to replace a hip joint |
82 | 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 |
83 | Orthopaedic Implants | Shoulder joint metal/metal or metal/polymer constrained cemented prosthesis | Class C | Intended to be implanted to replace a shoulder joint |
84 | Orthopaedic Implants | Wrist joint carpal lunate polymer prosthesis | Class C | Intended to be implanted to replace the carpal lunate bone of the wrist. |
85 | Orthopaedic Implants | Wrist joint metal/polymer semi-constrained cemented prosthesis | Class C | Intended to be implanted to replace a wrist joint. |
86 | Orthopaedic Implants | Wrist joint metal constrained cemented prosthesis. | Class C | Intended to be implanted to replace a wrist joint. |
87 | Orthopaedic Implants | Wrist joint polymer constrained prosthesis | Class C | Intended to be implanted to replace a wrist joint |
88 | Orthopaedic Implants | Wrist joint carpal trapezium polymer prosthesis. | Class C | Intended to be implanted to replace the carpal trapezium bone of the wrist. |
89 | Orthopaedic Implants | Wrist joint carpal scaphoid polymer prosthesis. | Class C | Intended to be implanted to replace the carpal scaphoid bone of the wrist. |
90 | 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. |
91 | Orthopaedic Implants | Toe joint polymer constrained prosthesis | Class C | Intended to be implanted to replace the first metatarsophalangeal (big toe) joint. |
92 | Orthopaedic Implants | Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis. | Class C | A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis. |
93 | Orthopaedic Implants | Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis. | Class C | A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis. |
94 | 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 |
95 | 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. |
96 | Orthopaedic Implants | Shoulder joint metal/polymer semi-constrained cemented prosthesis | Class C | Intended to be implanted to replace a shoulder joint |
97 | Orthopaedic Implants | shoulder joint metal/polymer non-constrained cemented prosthesis. | Class C | Intended to be implanted to replace a shoulder joint. |
98 | Orthopaedic Implants | Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis. | Class C | Intended to be implanted to replace part of a knee joint. |
99 | 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 . |
100 | Orthopaedic Implants | knee joint femoral (hemi-knee) metallic uncemented prosthesis | Class C | Intended to be implanted to replace part of a knee joint. |
101 | Orthopaedic Implants | knee joint patellofemorotibial metal/polymer. | Class C | Intended to be implanted to replace a knee joint. |
102 | Orthopaedic Implants | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis. | Class C | Intended to be implanted to replace a knee joint |
103 | Orthopaedic Implants | Knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis | Class C | Intended to be implanted to replace a knee join |
104 | 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. |
105 | 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. |
106 | Orthopaedic Implants | Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis. | Class C | Intended to be implanted to replace part of a knee joint. |
107 | Orthopaedic Implants | Knee joint femorotibial metal/polymer non-constrained cemented prosthesis | Class C | Intended to be implanted to replace part of a knee joint. |
108 | Orthopaedic Implants | Knee joint femorotibial metal/polymer constrained cemented prosthesis. | Class C | Knee joint femorotibial metal/polymer constrained cemented prosthesis. |
109 | Orthopaedic Implants | Knee joint femorotibial metal/polymer constrained cemented prosthesis. | Class C | Intended to be implanted to replace part of a knee joint. |
110 | Orthopaedic Implants | Knee joint femorotibial metal/composite semi-constrained cemented prosthesis. | Class C | Intended to be implanted to replace part of a knee joint. |
111 | Orthopaedic Implants | Knee joint femorotibial metal/composite non-constrained cemented prosthesis. | Class C | Intended to be implanted to replace part of a knee joint. |
112 | 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 |
113 | 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. |
114 | 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. |
115 | 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 |
116 | 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. |
117 | Orthopaedic Implants | Sacroiliac joint fixation | Class C | The sacroiliac joints fixation may serve as protective mechanism for the lumbosacral region. |
118 | Surgical Dressings | Wound Dressings/Bacterio static Wound Dressings | Class C | Includes Beads, Hydrophilics For Wound Exudate Absorption for wound care. |
119 | Surgical Dressings | Haemostatic Gelatine Sponge /Haemostat | Class C | Intended for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes |
120 | 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. |
121 | 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. |
122 | Surgical Dressings | Suture Absorable | Class C | The device is intended for use in general soft tissue approximation and ligation. |
123 | 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. |
124 | Surgical Dressings | Fixation, non-absorbable for pelvic use. | Class C | Attaching suture or stapling ligaments of the pelvic floor. |
125 | 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. |