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CDSCO Registration for Gastroenterological Medical Devices

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A Brief Introduction of Gastroenterological

The study of functioning and diseases of esophagus, stomach, small intestine, colon and rectum, pancreas, gallbladder, bile duct and liver is known as Gastroenterology. Gastroenterology contains detailed information regarding physiology of the gastrointestinal organs which includes complete movement of the material which moves through stomach and intestine (mobility), digestion and absorption system of food and nutrients into our body, removal of all the waste from our digestive system, functioning of the liver organ in our digestive system. There are some common and important conditions in gastroenterological like colon polyps and cancer, hepatitis, gastroesophageal reflux (heartburn), peptic ulcer disease, colitis, gallbladder and biliary tract disease, nutritional problems, IBS (irritable bowel syndrome), and pancreatitis. So Gastroenterology contains all the information about all regular activity and disease of the organs of our digestive systems.

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From 1st of October 2022, the said medical devices having risk class A and B will be covered under the licensing regime of CDSCO. Once the devices are under the scope of licensing regime of CDSCO, all the importers and manufacturers of the said devices will have to apply for the license in order to sell their products in Indian Market.

The Gastroenterological category consist of total 125 medical devices which are classified on the basis of their risk class and intended use. Out of which only class A and class B medical devices will fall under the licensing regime from 1 October 2022. The CDSCO listed medical devices are as below mentioned

Gastroenterological
S. No. Name of Product Intended Use Classification India as per First Schedule Part 1 MDR 2017
1 Absorbent enteric stomal dressing To be placed over a continent enteric stoma (surgically-created artificial opening between the intestines and the body surface through which bodily waste is drained from the intestines) to protect it from harmful external influences, which includes absorbent materials intended to protect the surrounding skin from enteric fluids. B
2 Anal fistula circular cutter To be intended for the circumferential resection of tissue to treat simple anal fistula B
3 Anoscope, reusable An endoscope with a rigid inserted portion intended for the visual examination and treatment of the anus and rectum. B
4 Anoscope, single-use A sterile endoscope with a rigid inserted portion intended for the visual examination and treatment of the anus and rectum. B
5 Barium enema catheter A flexible tube designed to administer barium, a contrast medium, into the lower gastrointestinal tract by way of the rectum, for radiographic visualization of the area. B
6 Biliary manometric catheter A sterile, non-electrical flexible tube intended to be inserted into the biliary tree to measure pressures within the ducts, especially to evaluate sphincter of Oddi function. B
7 Catheter-balloon inflator, reprocessed A sterile device designed to manually inflate and regulate the pressure of a balloon catheter (e.g., by injecting and aspirating fluid or air within the balloon), and to deflate the balloon during a medical procedure.It is typically used during angiography, angioplasty, gastrointestinal (GI), or sinuplasty procedures. B
8 Catheter-balloon inflator, reusable A device designed to manually inflate and regulate the pressure of a balloon catheter (e.g., by injecting and aspirating fluid or air within the balloon), and to deflate the balloon during a medical procedure. B
9 Catheter-balloon inflator, single-use A sterile device designed to manually inflate and regulate the pressure of a balloon catheter (e.g., by injecting and aspirating fluid or air within the balloon), and to deflate the balloon during a medical procedure. B
10 Cholangiopancreatography catheter, reusable A flexible tube inserted through a flexible endoscope, after its placement in the duodenum via the oral cavity, for the endoscopic cannulation of the gastrointestinal ductal system (i.e., the pancreatic, hepatic, and/or common bile ducts) during endoscopic retrograde cholangiopancreatography (ERCP). B
11 Cholangiopancreatography catheter, single-use A flexible tube inserted through a flexible endoscope, after its placement in the duodenum via the oral cavity, intended for the endoscopic cannulation of the gastrointestinal ductal system (i.e., the pancreatic, hepatic, and/or common bile ducts) during endoscopic retrograde cholangiopancreatography (ERCP). B
12 Closed-ended intestinal ostomy bag, multiple-piece A non-sterile plastic pouch designed to be attached around a faecal stoma for use as a receptacle for faeces following a colostomy [the stool (faeces) being generally well formed]. A
13 Closed-ended intestinal ostomy bag, one-piece A non-sterile plastic pouch designed to be attached with an adhesive to the skin around a faecal stoma and used as a receptacle for faeces following a colostomy [the stool (faeces) being generally well formed]. A
14 Colonic endoscopy cuff A sterile distal attachment to a flexible endoscope intended to improve endoscopic control and bowel visualization during colonic endoscopy. B
15 Colonic lavage kit, surgical A collection of sterile devices intended to be used during open colorectal surgery (bowel resection) to irrigate the colon above (proximal to) the site of a lesion/blockage, prior to surgical anastomosis, when preoperative preparation of the colon has not been possible, normally due to obstruction. B
16 Colonoscope positioning sleeve A non-sterile endoscopic sheath with two inflatable balloons designed to be mounted on a colonoscope to position and stabilize the endoscope within the large intestine of a patient. B
17 Colonoscope stiffener A dedicated stiff wire that is inserted into a flexible colonoscope to allow the physician to increase the stiffness of the colonoscope when extra rigidity is required during a colonoscopy. B
18 Colorectal sizer A hand-held manual surgical instrument designed to assess colon and/or rectal lumen diameter to aid the selection of an appropriate size intraluminal stapler (i. e, the stapler head) for bowel anastomosis following transection. B
19 Common bile duct dilator A hand-held manual surgical instrument designed to dilate the common bile duct, i.e., the union of the cystic and hepatic ducts. B
20 Endoscope tissue removal cap A sterile plastic tube designed to be placed onto the distal end of an endoscope (e.g., oesophagoscope) to facilitate the removal of coagulated blood/tissue during electrosurgical treatment (e.g., for the treatment of Barrett’s oesophagus). B
21 Endoscopic biopsy valve, non-sterile A non-sterile device intended to be fitted to an endoscope biopsy port to enable access for/exchange of endoscopic devices while maintaining insufflation and minimizing leakage of biomaterial during an endoscopic procedure. B
22 Endoscopic biopsy valve, sterile A sterile device intended to be fitted to an endoscope biopsy port to enable access for/exchange of endoscopic devices while maintaining insufflation and minimizing leakage of biomaterial during an endoscopic procedure. B
23 Endoscopic cutting stapler connector A rod-like component of an endoscopic cutting stapler intended to enable connection between the stapler handpiece and the endpiece/loading unit. B
24 Endoscopic electrosurgical biopsy/resection kit, full-thickness A collection of sterile devices, which includes an implantable haemostatic ligation clip, intended to be used to obtain a full-thickness tissue biopsy and/or therapeutic resection of gastric, duodenal, colonic, and/or rectal tissue during an endoscopic procedure. B
25 Endoscopic electrosurgical biopsy/resection kit, partial-thickness A collection of devices designed to be inserted through a compatible endoscope to obtain a mucosal tissue biopsy and/or therapeutic resection of upper gastrointestinal (GI) tract tissue, typically during endoscopic retrograde cholangiopancreatography (ERCP) procedures. B
26 Endoscopic electrosurgical electrode/submucosal lift needle A sterile, invasive, endoscopic device intended to deliver both: 1) a submucosal lifting solution; and 2) an electrosurgical current in a monopolar configuration (i.e., with a return electrode) to tissues for cutting/coagulation. B
27 Endoscopic gastrointestinal stenosis dilator A sterile invasive device intended to be used to dilate or expand a narrowing lesion (e.g., oesophageal stricture, stenosis) in the lumen of the gastrointestinal [GI] tract, under endoscopic visualization. B
28 Endoscopic motorized cutting stapler, reusable A hand-held, battery-powered surgical instrument designed to be used during endoscopic surgical procedures for the expeditious transection and resection of tissues and the creation of anastomoses. B
29 Endoscopic motorized cutting stapler, single-use A sterile, hand-held, battery-powered surgical instrument designed to be used during endoscopic surgical procedures for the expeditious transection and resection of tissues and the creation of anastomoses. B
30 Endoscopic needleless submucosal lift catheter A sterile, flexible tube intended to non-invasively deliver a submucosal lifting solution into the submucosa of the gastrointestinal tract through a flexible endoscope during an endoscopic procedure (e.g., gastroscopy, colonoscopy) to lift a lesion, typically for subsequent excision. B
31 Endoscopic overtube, reusable A tubular device intended to be used in combination with a compatible flexible endoscope to aid in endoscopic insertions and to secure a pathway for multiple endoscopic intubations during diagnostic and therapeutic endoscopic procedures (e.g., upper and/or lower gastrointestinal (GI) tract endoscopy). B
32 Endoscopic spray catheter A sterile, flexible tube intended to be used with an endoscope (e.g., colonoscope) to administer fluids (e.g., dyes for mucosal coloration) in spray form. B
33 Enema tip, reusable A non-sterile device made with Hevea natural rubber latex (NRL) intended to be connected to an enema tube to facilitate delivery of an enema solution into the rectum. A
34 Enema tube A non-sterile, length of tubing that is used as a conduit between the enema bag and the enema tip for the delivery of the enema solution into the rectum. A
35 Enteral feeding/decompression tube clearing stem A non-sterile, sheath-covered device intended to be used to mechanically clear a clog in an in situ nasogastric, nasoenteral, gastrostomy and/or jejunostomy tube, used for feeding and/or decompression, to maintain luminal patency. A
36 Enteral tube extension, non-sterile A non-sterile, thin, flexible tube intended for extracorporeal connection to an enteral feeding tube (e.g., nasogastric tube) to increase the length of tubing from the patient to an oral/enteral device (e.g., syringe) during enteral feeding/medication administration or aspiration. A
37 Enteral tube extension, sterile A sterile, thin, flexible tube intended for extracorporeal connection to an enteral feeding tube (e.g., nasogastric tube) to increase the length of tubing from the patient to an oral/enteral device (e.g., syringe) during enteral feeding/medication administration or aspiration. A
38 Externally-propelled flexible video colonoscope A non-sterile endoscope with a highly flexible sleeve and distal tip intended for the visual examination of the entire adult colon [lower gastrointestinal (GI) tract]. B
39 Flexible fibreoptic choledochoscope An endoscope with a flexible inserted portion intended for the visual examination and treatment of the choledoc, better known as the common bile duct (CBD). B
40 Flexible fibreoptic colonoscope An endoscope with a flexible inserted portion intended for the visual examination and treatment of the entire colon [lower gastrointestinal (GI) tract]. B
41 Flexible fibreoptic duodenoscope An endoscope with a flexible inserted portion intended for the visual examination and treatment of the duodenum (the first part of the small intestine). B
42 Flexible fibreoptic enteroscopy An endoscope with a flexible inserted portion intended for the visual examination and treatment of the small intestine (the duodenum, jejunum, and ileum). B
43 Flexible fibreoptic gastroduodenoscope An endoscope with a flexible inserted portion intended for the visual examination and treatment of the upper gastrointestinal (GI) tract [oesophagus, stomach, and duodenum (the first part of the small intestine), including the pancreas and the bile duct]. B
44 Flexible fibreoptic gastroscope An endoscope with a flexible inserted portion intended for the visual examination and treatment of the oesophagus and the stomach. B
45 Flexible fibreoptic esophagoscope An endoscope with a flexible inserted portion intended the visual examination and treatment of the oesophagus. B
46 Flexible fibreoptic pancreatoscope An endoscope with a flexible inserted portion intended for the visual examination and treatment in the pancreas. B
47 Flexible fibreoptic sigmoidoscope An endoscope with a flexible inserted portion intended for the visual examination and treatment of the sigmoid colon (the distal S-shaped part of the large intestine leading to the rectum). B
48 Flexible ultrasound colonoscope An endoscope with a flexible inserted portion intended for the visual examination and treatment of the entire colon [lower gastrointestinal (GI) tract]. B
49 Flexible ultrasound duodenoscope An endoscope with a flexible inserted portion, combined with an ultrasound probe, intended for the visual examination and treatment of the duodenum (the first part of the small intestine). B
50 Flexible ultrasound gastro duodenoscopy An endoscope with a flexible inserted portion, combined with an ultrasound probe, intended for the visual examination and treatment of the upper gastrointestinal (GI) tract [oesophagus, stomach, and duodenum (the first part of the small intestine), including the pancreas and the bile duct]. B
51 Flexible video choledochoscope An endoscope with a flexible inserted portion intended for the visual examination and treatment of the choledoc, better known as the common bile duct (CBD). B
52 Flexible video choledochoscope, single-use An endoscope with a flexible inserted portion intended for the visual examination and treatment of the biliary tract and related ducts [e.g., common bile duct (CBD), cystic duct, pancreatic duct], and for the removal of gallstones. B
53 Flexible video colonoscope, reusable An endoscope with a flexible inserted portion intended for the visual examination and treatment of the entire colon [lower gastrointestinal (GI) tract]. B
54 Flexible video colonoscope, single-use A sterile endoscope with a flexible inserted portion intended for the visual examination and treatment of the entire colon [lower gastrointestinal (GI) tract]. B
55 Flexible video duodenoscope, reusable An endoscope with a flexible inserted portion intended for the visual examination and treatment of the duodenum (the first part of the small intestine). B
56 Flexible video duodenoscope, single-use An endoscope with a flexible inserted portion intended for the visual examination and treatment of the duodenum (the first part of the small intestine). B
57 Flexible video enteroscope An endoscope with a flexible inserted portion intended for the visual examination and treatment of the small intestine (the duodenum, jejunum, and ileum). B
58 Flexible video gastroduodenoscope An endoscope with a flexible inserted portion intended for the visual examination and treatment of the upper gastrointestinal (GI) tract [oesophagus, stomach, and duodenum (the first part of the small intestine), including the pancreas and the bile duct]. B
59 Flexible video gastroscope An endoscope with a flexible inserted portion intended for the visual examination and treatment of the oesophagus and the stomach. B
60 Flexible video oesophagoscope, reusable An endoscope with a flexible inserted portion intended for the visual examination and treatment of the oesophagus. It is inserted into the body through the mouth. Anatomical images are obtained via a camera incorporated at the distal end of the oesophagoscope and are shown on a monitor. This device is commonly used to examine abnormalities in the tissue structure and mucous lining of the oesophagus. This is a reusable device. B
61 Flexible video oesophagoscope, single-use An endoscope with a flexible inserted portion intended for the visual examination and treatment of the oesophagus. B
62 Flexible video pancreatoscope An endoscope with a flexible inserted portion intended for the visual examination and treatment in the pancreas. B
63 Flexible video sigmoidoscope An endoscope with a flexible inserted portion intended for the visual examination and treatment of the sigmoid colon (the distal S-shaped part of the large intestine leading to the rectum). B
64 Gastric tonometry catheter A sterile flexible tube intended for orogastric, nasogastric, or rectal insertion to sample carbon dioxide (CO2) from the mucosal vasculature of the stomach or sigmoid colon for the measurement of partial pressure (i.e., tonometry) of CO2 (pCO2) during diagnosis of mensenteric ischemia. B
65 Gastrointestinal catheter/endoscope tracking system A multicomponent assembly of mains electricity (AC-powered) devices designed for real-time visualization/navigation of a catheter and/or endoscope during insertion in the gastrointestinal tract, by detecting its position/movement within an electromagnetic (EM) field and displaying three- dimensional (3-D) virtual images on a monitoring screen. B
66 Gastrointestinal endoscopic clip applier A device intended to be used in combination with a compatible flexible endoscope for the application of a gastrointestinal endoscopic clip(s) [not included] to the mucosal lining of the gastrointestinal (GI) tract for endoscopic marking, haemostasis, tissue approximation, closure of luminal perforations, and/or for treating mucosal/submucosal defects during an endoscopic procedure. B
67 Gastrointestinal endoscopic clip cutter A sterile device intended to be used in combination with a generator to remove a gastrointestinal endoscopic clip. B
68 Gastrointestinal endoscopic clip cutter generator A portable, mains electricity (AC-powered) device intended to be used in conjunction with a cutter for the endoscopic removal of a gastrointestinal endoscopic clip. B
69 Gastrointestinal manometric catheter, electronic A non-sterile flexible tube with electronic sensors at the distal end intended to be inserted through the nose or rectum into the gastrointestinal (GI) tract to evaluate peristaltic motility anywhere in the GI tract (pharynx, oesophagus, stomach, duodenum, small bowel, colon, and anorectal area) by measuring pressure; it may additionally be intended to measure pH and electrical impedance and contain a lumen. B
70 Gastrointestinal manometric catheter, non-electronic A non-sterile, non-electrical flexible tube intended to be inserted through the nose or rectum into the gastrointestinal (GI) tract for measuring pressure to assess peristaltic motility in the GI tract (e.g., oesophagus, stomach) or rectal musculature and anal sphincter functions, typically in the evaluation of GI disorders [e.g., gastro-oesophageal reflux disease (GERD), faecal incontinence]. A
71 Gastrointestinal ostomy tube pocket A non-sterile, noninvasive pouch designed to be wrapped around the protruding end of a gastrointestinal ostomy tube (e.g., gastrostomy or jejunostomy tube) to hold and support it in order to ensure its stabilization on the patient. B
72 Gastrointestinal/airway foreign body retrieval basket A flexible device intended to access the gastrointestinal (GI) tract, and/or the airway tree, via the working channel of an appropriate endoscope to atraumatically remove foreign bodies during an endoscopic procedure; it may in addition be intended for removal of severed polyps and tissue samples (biopsy). B
73 Gastro-oesophageal pH/impedance catheter, non-sterile A non-sterile flexible tube with electronic sensors at its distal end intended to be inserted through the nose into the oesophagus and stomach to measure pH and/or electrical impedance, typically for the evaluation of gastro-oesophageal reflux disease (GERD), gastric ulcers, or other gastrointestinal conditions. B
74 Gastro-oesophageal pH/impedance catheter, sterile A sterile flexible tube with an with an electrical conductor at its distal end intended to be inserted through the nose into the oesophagus and stomach to measure pH and/or electrical impedance, typically for the evaluation of gastro-oesophageal reflux disease (GERD), gastric ulcers, or other gastrointestinal conditions. B
75 Gastrostomy tube Y-piece connector A sterile connecting device shaped in the form of a "Y" intended for connection to the proximal end of a gastrostomy tube to enable administration of nutrient liquids and/or medication through the gastrostomy tube. B
76 Gastro-urological director A slender, rod-like surgical instrument made of metal, typically with a groove running along the centre of it distal shaft and/or continuing with an elongated malleable wire loop, that is used to guide other devices or instruments into a selected intracorporeal location during a gastroenterological/urological (GU) procedure. B
77 Gastro-urological probe A slender, rod-like, hand-held manual surgical instrument, typically made of flexible metal with a blunt bulbous tip, designed for exploring gastroenterological/urological (GU) structures during a GU procedure. B
78 Gastro-urological scoop A heavy, hand-held, manual surgical instrument with a spoon-like, sharp-edged distal end on a long thin shaft that is used to access and scrape tissue from the common hepatic/bile duct system during a gastroenterological/urological (GU) procedure. A
79 Gravity enema set A collection of devices intended to be used to deliver an injection of fluid (e.g., saline solution) into the rectum to facilitate evacuation of the large intestine. A
80 Intestinal ostomy bag anti-adhesion device A non-sterile, noninvasive device intended to be applied to the inner surface of an intestinal ostomy bag to prevent opposing inner walls of the bag from sticking together (anti-pancaking). A
81 Intestinal ostomy kit A collection of non-sterile devices intended to be used for attachment/replacement of an intestinal ostomy bag (for collecting intestinal output such as faeces following a colostomy or ileostomy procedure). B
82 Intestinal stoma shield/support belt, reusable A non-sterile plate, typically with a waist belt for attachment, intended to be placed over an enteric stoma (surgically-created artificial opening between the intestines and the body surface through which bodily waste is drained) to protect it from harmful external influences (e.g., knocks, friction), to reduce the risk of stomal herniation, or to help maintain adhesion of the base plate to the skin. B
83 Intestinal stoma shield/support belt, single-use A non-sterile plate, typically with a waist belt for attachment, intended to be placed over an enteric stoma (surgically-created artificial opening between the intestines and the body surface through which bodily waste is drained) to protect it from harmful external influences (e.g., knocks, friction), to reduce the risk of stomal herniation, or to help maintain adhesion of the base plate to the skin. B
84 Intraluminal oesophageal retractor A sterile, hand-held manual surgical instrument intended to be inserted through an orogastric (or nasogastric) tube to mechanically divert the oesophagus away from the site of surgery during electrical treatments of the heart (e.g., cardiac ablation), to facilitate surgical site access and to help prevent injury to the oesophagus. B
85 Invasive silicone sheet dressing A sterile, flat stretch of silicone elastomer intended for use as a short-term intra-abdominal dressing following abdominal surgery, when a re-exploration of the wound/abdomen is planned within a thirty day period. It is used to achieve temporary abdominal closure to avoid the complications of an open abdomen. B
86 Laparoscopic cholangiography catheter/needle A sterile, flexible, single-lumen tube with a distal needle intended to puncture the neck of the gallbladder (Hartmann’s pouch) during laparoscopic cholangiography to allow injection of contrast media. B
87 Laparoscopic grasping forceps, reprocessed A sterile, rigid surgical instrument designed to be introduced through a laparoscope primarily for grasping and manipulating tissues during a laparoscopic surgical procedure. B
88 Laparoscopic grasping forceps, reusable A rigid surgical instrument designed to be introduced through a laparoscope primarily for grasping and manipulating tissues during a laparoscopic surgical procedure. B
89 Laparoscopic grasping forceps, single-use A sterile, rigid surgical instrument designed to be introduced through a laparoscope primarily for grasping and manipulating tissues during a laparoscopic surgical procedure. B
90 Laparoscopic swab forceps An instrument designed to grasp a pledget swab at the distal end to obtain cytological specimens and/or to perform blunt dissection during gynaecologic and/or other (e.g., cholecystectomy) laparoscopic procedures. B
91 Manual enema device A non-sterile device intended to be used to manually administer fluid (e.g., saline solution) into the rectum to facilitate the evacuation of the large intestine through expansion of the lower intestinal tract and physical stimulation of peristalsis. B
92 Manual enema device, reusable A device intended to be used to manually administer fluid (e.g., saline solution) into the rectum to facilitate evacuation of the large intestine through expansion of the lower intestinal tract and physical stimulation of peristalsis. B
93 Manual rectal irrigation system A portable assembly of manually-operated devices designed to be used by or on a patient to irrigate the rectum with water, typically to provoke the defecation reflex for the evacuation of the bowels to treat/prevent constipation and reduce the risk of faecal incontinence. B
94 Motorized laparoscopic forceps A mains electricity (AC-powered) motorized surgical instrument designed for grasping, mobilizing, and suturing tissues/vessels under direct or endoscopic visualization during a surgical procedure. B
95 Nasogastric decompression tube A sterile, thin, flexible, hollow, single- or double-lumen cylinder intended to access the stomach of a patient through the nose and nasopharynx primarily to reduce the pressure within the gastrointestinal tract, typically aided by connection to an intermittent suction system, that may follow presurgical or postsurgical intestinal occlusion. B
96 Nasogastric tube holder, intranasal A non-sterile, non-surgically invasive device intended to be used to secure a nasogastric tube to the nose of a patient to prevent displacement or removal of the tube. A
97 Nasogastric tube holder, noninvasive, non-sterile A small, non-sterile, noninvasive device intended to be used to secure a nasogastric tube to prevent displacement or removal of the tube from the patient. A
98 Nasogastric tube holder, noninvasive, sterile A small, sterile, noninvasive device intended to be used to secure a nasogastric tube to prevent displacement or removal of the tube from the patient. B
99 Oesophageal temperature monitor An electronic device used to monitor the temperature of the oesophagus during surgical ablation of the wall of the left atrium. It typically measures the oesophageal temperature at several adjacent levels, and displays these temperature values simultaneously to help the surgeon avoid the application of heat high enough to form atrial-oesophageal fistulas. B
100 Over-guidewire oesophageal dilator A surgical instrument in the form of a slender, hollow cylinder made of metal, plastic or other suitable material, designed to dilate oesophageal strictures/passages after being passed over a pre-positioned guidewire, typically in sequentially increasing sizes. It is commonly used prior to and to assist in a gastroscopy and is available in a variety of sizes and flexibilities. B
101 Percutaneous biliary biopsy procedure kit A collection of sterile devices intended to be used to obtain a tissue specimen from within the biliary duct system for histological analysis by a percutaneous approach, typically under fluoroscopic visualization. B
102 Powered rectal/colostomy irrigation system A portable assembly of battery-powered devices intended to be used by, or on a patient, for the controlled introduction of a non-medicated solution (typically water) into the rectum to treat faecal incontinence or constipation (rectal irrigation), and/or for colostomy site irrigation. B
103 Proctoscope, reusable An endoscope with a rigid inserted portion intended for the visual examination and treatment of the rectum and anus. B
104 Proctoscope, single-use A sterile endoscope with a rigid inserted portion intended for the visual examination and treatment of the rectum and anus. B
105 Rectal irrigation kit A collection of non-sterile devices intended to be used as part of a rectal irrigation system for the introduction of a non-medicated solution (typically water) into the rectum for patients affected by faecal incontinence or constipation. B
106 Rectal speculum A hand-held manual surgical instrument intended to be used to expand or stretch the rectal orifice/canal after it is inserted and opened. B
107 Rectal suction biopsy system An assembly of disposable and reusable devices designed to obtain a submucosal tissue specimen from the rectum using suction [rectal suction biopsy (RSB)], typically for histopathological analysis [e.g., to help diagnose Hirschsprung's disease (HD)]. A
108 Rectal/colonic lavage support kit A collection of non-sterile, noninvasive devices intended to be used in conjunction with a rectal and/or colonic irrigation system to support the introduction of an irrigation solution into the rectum/colon. B
109 Rectoscope, reusable An endoscope with a rigid inserted portion intended for the visual examination and treatment of the rectum and anus. B
110 Rectoscope, single-use A sterile endoscope with a rigid inserted portion intended for the visual examination and treatment of the rectum and anus. A
111 Rectoscope/proctoscope handle A manual device intended to be used as a handle to hold a rectoscope or proctoscope during an examination procedure. A
112 Rectosocope/proctoscope handle end-cap A small cap intended to be fitted to the proximal end of the handle of a rectoscope or proctoscope during an examination procedure to provide an airtight seal so that air can be pumped through the scope to inflate the bowel. B
113 Rigid oesophagoscope An endoscope with a rigid inserted portion intended for the visual examination and treatment of the oesophagus. B
114 Rigid sigmoidoscope An endoscope with a rigid inserted portion intended for the visual examination and treatment of the sigmoid colon (the distal S-shaped part of the large intestine leading to the rectum). B
115 Robotic surgical retractor A surgical device intended to be used in conjunction with a robotic surgical system to enable retraction of tissues during a robotic endoscopic procedure. B
116 Self-propelled flexible video colonoscope A sterile endoscope with a highly-flexible, self-propelled, inserted portion intended for the visual examination of the entire colon. B
117 Spring-loaded pneumoperitoneum needle, reusable A slender, sharply-pointed metal tube designed to introduce or remove gas from the peritoneal cavity as a therapeutic or surgical/radiological procedural method. It is often inserted into the peritoneal cavity for the purpose of insufflation [e.g., with carbon dioxide (CO2)] to establish pneumoperitoneum prior to abdominal endoscopy. B
118 Spring-loaded pneumoperitoneum needle, single-use A slender, sharply-pointed metal tube designed to introduce or remove gas from the peritoneal cavity as a therapeutic or surgical/radiological procedural method. It is often inserted into the peritoneal cavity for the purpose of insufflation [e.g., with carbon dioxide (CO2)] to establish pneumoperitoneum prior to abdominal endoscopy. B
119 Static magnetic anal plug A non-sterile magnetic device designed to be inserted into the rectum by the user and retained there for a specified period of time (e.g., 1 to 2 hours per day for 10 to 20 days) to help reduce anal haemorrhoids with magnetism. B
120 Stoma drainage catheter A sterile flexible tube that is inserted into a stoma (an artificial opening in the body, especially in the abdominal wall, made during a surgical procedure) to drain bodily waste from an internal stoma container; normally directly into the toilet. B
121 TEM/TEO rectoscope, optical An endoscope with a rigid inserted portion intended for surgical treatment of the lower part of the bowel during transanal endoscopic microsurgery (TEM) or transanal endoscopic operations (TEO). B
122 TEM/TEO rectoscope, video An endoscope with a rigid inserted portion intended for surgical treatment of the lower part of the bowel during transanal endoscopic microsurgery (TEM) or transanal endoscopic operations (TEO). B
123 Video capsule endoscopy system An assembly of electronic devices designed for the internal visualization and examination of sections of the gastrointestinal (GI) tract using a non-digestible video capsule after it has been swallowed by a patient. B
124 Video capsule endoscopy system application software An individual software application program or group of programs, routines or algorithms that add specific computer assisted display, processing and analysis capabilities to a video capsule endoscopy system. B
125 Video capsule endoscopy system capsule A non-sterile, battery-powered, electronic component device of a video capsule endoscopy system designed to be swallowed by a patient for the internal visualization and examination of the gastrointestinal (GI) tract. B

Central Drugs Standard Control Organisation:

India is growing as one of the nation's leading in pharmaceutical business and is among the top ten nations in terms of the pharmaceutical industry. Several factors such as large population, growing health awareness, affordable medical facilities, and better research facilities have given rise to the manufacturing and development of pharma business in India. However, with the increasing scope for the growth of the pharma industry in India, there are possibilities for the sale/purchase of medical equipment & device illegally or without jurisdiction. Therefore, the Government of India has established the Central Drug Standards Control Organization (CDSCO), which is the primary legislative body and has been responsible for the regulation, control, and management of pharmaceuticals and medical devices in India apart from the appointment of the Drug Controller General of India (DCGI), and has conferred the responsibility of undertaking assessment, approval and regulation of further compliances(import, export, sale, distribution) in the matters of medicinal drugs and medical devices(including any existing or any new) drugs/devices in accordance with the provisions of the Drugs and Cosmetics Act 1940.

NOC from the CDSCOConsequently, To date, about 37 categories of medical devices have been regulated or notified as drugs under the Drugs & Cosmetics 1940. While the notified medical devices/equipment need to obtain registration for their manufacture or import in India, the medical devices that are not recognized need to obtain a NOC from the CDSCO.

What is a Medical Device?

According to the latest definition as provided under the Medical Devices Amendment rules 2020, as notified on 11.02.2020. However, taking care of circumstances the government has exercised its powers to include more categories by widening the scope of the definition of “Medical Device” under the Act. It states-

"Devices used in general medical practice such as medical apparatus, instruments, implants appliance, etc., which are either used individually or in combination, and are intended to be specifically applied for human beings or animals and are further intended to obtain the desired function by such means and for such purposes as provided below, but is not intended to meet the primary intended action on human body or animals by any pharmacological or immunological or metabolic means-  

  • Analysis, prevention, observing, treatment, or mitigation of any disease or disorder;
  • Analysis, observing, treatment, mitigation, or support for any injury or disability;
  • Examination, replacement or alteration or support in findings of the anatomy or a physiological process;
  • For supporting or sustaining life;
  • Decontamination of medical devices; and
  • Conception related equipment’s & devices.

Therefore, every manufacturer or importer or both of any medical devices in India shall be required to obtain registration as per the provisions of the Drugs and Cosmetics Act 1940. Any failure to comply with the same may invite legal action including penalty & prosecution under the Act.

Types of Medical Devices in India

Provisions related to the import, manufacture, sale & distribution of medical devices are regulated under the provisions of the drug and cosmetics Act 1945. Under the New Medical Rules 2017, all medical devices have been classified into four different categories depending on their usability & risk involved as provided below. 

Types of Medical Devices in India

  • Class A:- Low-risk devices like a thermometer, tongue depressors, etc.
  • Class B:- Low moderate risk like Hypodermic Needles, suction equipment, etc.
  • Class C:- Moderate high-risk devices like Lung ventilator, etc.
  • Class D:- High-risk devices like Heart valves, implantable devices, etc.

Where Class A & B devices are considered to be less risky and moderate devices, for which the application to manufacture has to be filed to the State Licensing Authority. Whereas Class C &D are considered to be high and very High-risk devices and the application for these has to be filed to the Central Licensing Authority of India.

Eligibility Criteria for Medical Devices Registration/Import

The provisions related to activities such as Import, manufacture, sale, and distribution of medical devices have been regulated under the provisions of the Drugs & Cosmetic Act 1940 & Rules 1945. Therefore, any person/firm/enterprise, etc. holding a wholesale drug license and/or manufacturing license issued under the Drugs and Cosmetics Act, 1940 and Rules 1945 could make an application for Registration and import of medical devices into India.

Process & Fee for Medical Devices Registration

Types of Medical Devices Registration

  • Registration/Import of any existing medical device;
  • Registration /import of any new medical device

Process Medical Devices Registration

Step 1: Determine whether your medical device is under notified list or not

The CDSCO authority has provided a list of notified medical devices that need to compulsorily obtain registration under the Drugs and Cosmetics Act 1940 and in accordance with Medical devices rules 2017. However, there may be any medical devices that have not been expressly notified by the CDSCO authority, or in case of new medical equipment, the manufacturer/importer shall be required to obtain a NOC in such cases. For instance, Blood Grouping Sera Ligatures, Sutures, Staples Intra-Uterine Devices (Cu-T), Condoms, Tubal Rings, Surgical Dressing, Umbilical Tapes, Blood / Blood Component Bags do not need registration, whereas devices such as spinal needles, cochlear implants, syringes, and needles, heart valves, endotracheal tubes and catheters among others should undergo registration provides with the CDSCO.

Step 2:  Appoint an Authorized representative (in case of Foreign Entity)

For a foreign business manufacturer entity, it shall be necessary to appoint an authorized business entity in India, who shall be the contact person for the inspection authorities during the process, assist in device approvals, and registrations process, and vigilance adverse event reporting. The Indian Authorization should hold a wholesale drug license in forms 20B& 21B. 

Step 3:   Fill out the applicable form for Medical device Registration

In the next step, the manufacturer/importer for MD shall be required to submit the registration form of a regulatory dossier, along with all the prescribed documents along with the prescribed fee on the CDSCO portal to the DGCI (Drugs Controller General of India) by logging on to the online CDSCO portal https://cdsco.gov.in/opencms/opencms/en/Home/ and signing into the portal.

Following forms along with applicable govt. fees have been provided below, which shall be required to be paid through payment challan-

Applicant Type Class of MD Application Form License Form
Importer A,B,C,D MD-14 MD-15
Manufacturer A B MD-3 MD-5
Manufacturer(Loan License) A B MD-4 MD-6
Manufacturer C, D MD-7 MD-9
Manufacturer(Loan License) C, D MD-8 MD-10

However, in the case of new equipment or medical device-

Application  Type Class of MD Application Form License Form
Importer Clinical Investigation A,B,C,D MD-22 MD-23
Import License A,B,C,D MD-26 MD-27
Test License(for importer) A,B,C,D MD-16 MD-17
Manufacturer (Clinical investigation) A,B,C,D MD-22 MD-23
Manufacturer License A,B,C,D MD-26 MD-27
Test License A,B,C,D MD-16 MD-17

Further, each application shall be supported with the list of documents and the requisite fee as provided in the online portal of CDSCO-

Type of License  Class of Device Applicable Regulation Govt. Fee

For Manufacturing/Loan License

  • For one site
  • For each device
A or B; 20(2) Rs. 5000
Rs. 500

For Manufacturing/Loan License

  • For one site
  • For each device
C or D; 21(2) Rs. 50,000
Rs. 500

For Import License(other than IVD)

  • For one site
  • For each device
Class A 34(2) 1000 Dollar
50 Dollar

Import License(other than IVD)

  • For one site
  • For each device
Class B 34(2) 2000 Dollar
1000 Dollar

Import License (in IVD)

  • For one site
  • For each device
Class A or B 34(2) Rs. 1000
Rs. 10

Import License (other than IVD)

  • For one site
  • For each device
Class C or D 34(2) 3000 Dollar
1500 Dollar

Import License(in IVD)

  • For one site
  • For each device
C or D 34(2) 3000 Dollar
500 Dollar

Step 4: Obtain Certificate of Registration in Prescribed form 

Once the application is submitted on the CDSCO portal, the DGCI registration authority may send a query through an inquiry letter to the manufacturer or from the authorized representative of the importer, along with the timeline within which the query should be answered and sometimes, may also ask for a technical presentation On satisfaction the authority may issue a license in such form as provided in the above list. After obtaining registration, the manufacturer or his authorized representative may apply for an importer license.

Documents required to be attached

  • Form 40
  • ISO 13485 certificate
  • Full Quality Assurance Certificate
  • CE Design Certificate
  • Undertaking that all information provided is authentic
  • Either a Free Sale Certificate or Certificate from the Foreign Government 
  • Certificate of Marketability from GHTF (Australia, Canada, Japan, the European Union, and the United States);
  • Plant Master Report
  • Device Master File

Time Involved &Validity for Registration

If the DGCI doesn’t ask for a Technical Presentation or Subject Expert Committee (SEC) audit, it takes around 6-9 months to obtain a Medical Devices Registration. In cases where Technical Presentation or Subject Expert Committee (SEC) audit, is required, it may take additional 3-6 months. 

Once obtained the Registration Certificate shall be valid for a total period of 3 years from the date of issue of registration unless suspended or cancelled by the DGCI authority for proper causes.

Re-registration or Renewal of the Registration Certificate

The application for renewal of the MD registration certificate shall be made at least nine months from the expiry of the registration certificate. Though there are no additional requirements for the renewal of registration, it shall be necessary for the certificate holder to provide a copy of the Plant Master File (PMF) and Device Master File (DMF), where there are no changes in the PMF and DMF, 

Post-Compliances after Receiving Registration

Though there are not many compliances in place about the registration certificate, it shall be compulsory for the certificate holder to-

  • In case of any change that has taken place about the constitution of the firm and/or address of the registered office/factory premises, the MD manufacturer/authorized representative of the importer to intimate the licensing authority regarding the same in writing;
  • In case any such change has taken place, the existing registration certificate shall be valid for a maximum period of three months from the date on which the change has taken place, and during this time, the manufacturer/authorized representative shall be required to obtain a fresh Registration Certificate; 

How to Register any new/additional Medical Device if Medical Device Registration Obtained Already?

In case an importer wants to obtain registration for manufacturing of any additional manufacturing device, then such person shall be required to obtain an endorsement to the existing Registration Certificate along with the prescribed documents holding that manufacturing of an additional device is being undertaken in the manufacturing site as provided in the registration certificate along with a fee of 1000 dollars fee for each additional device.

This portion of the site is for informational purposes only. The content is not legal advice. The statements and opinions are the expression of author, not corpseed, and have not been evaluated by corpseed for accuracy, completeness, or changes in the law.

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Author
Surbhit Sharma
I have worked for many internet blog pages and news portals. currently, I am working as a content writer for Corpseed Pvt. Ltd. I like to write blogs and articles in the field of different services.

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