admin[@]morulaa[dot]com

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

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: NoName of the Devices
1Disposable Hypodermic Syringes
2Disposable Hypodermic Needles
3Disposable Perfusion Sets
4In vitro Diagnostic Devices for HIV, HbsAg and HCV
5Cardiac Stents
6Drug Eluting Stents
7Catheters
8Intra Ocular Lenses
9I.V. Cannulae
10Bone Cements
11Heart Valves
12Scalp Vein Set
13Orthopaedic Implants
14Internal Prosthetic Replacements
15Ablation 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.

Let’s Talk

Request your free proposal. Call us today, or fill out the form and we will get right back to you!

Let’s Talk

Request your free proposal. Call us today, or fill out the form and we will get right back to you!