Introduction – Urology as Medical Device India
This article deals with the latest rules of Urology Products as a Medical Device India – Non Notified Medical Device Registration. Indian healthcare regulators at the Central Drugs Standard Control Organization (CDSCO) have issued substantial new risk-based classification lists for Urology as a Medical Device in India. All Urology Products now need to be registered in order to comply with the latest Medical Device Rules in India ( i.e 30th September, 2021). Below is a table which helps manufacturers classify their products and apply with the Indian Health Ministry Accordingly. The total number of Devices classified are 42.
Table: Urology as Medical Device India
| S.No. | Medical Device Name | Intended Use | Risk Class |
| 1 | Absorbable peritoneal catheter cuff | Intended to maintain stable contact between the skin and the peritoneal dialysis catheter, and prevents bacterial invasion from the outlet. It is embedded subcutaneously at the outlet of the peritoneal dialysis catheter. | D |
| 2 | Automated peritoneal dialysis system | An active medical device intended to perform peritoneal dialysis. | C |
| 3 | Urinary stone retrieval basket | Intended to remove urinary stones (renal calculi) from the body during an endoscopic procedure. | B |
| 4 | Chair, Haemodialysis, Electrically powered/Manual. | Intended to support the patient in a seated or reclined posture during haemodialysis procedures. | A |
| 5 | Collagen-containing peritoneumabsorbable catheter cuff | A cuff that consists of biodegradable porous material containing collagen, intended to be embedded subcutaneously at the outlet of the peritoneal dialysis catheter. | D |
| 6 | Crimp for plier, Haemodialysis | Intended to manipulate the arteriovenous shunt of patients required hemodialysis. | A |
| 7 | Dialyser connector | Intended to connect between a dialysis fluid circuit and dialyzer, etc. | B |
| 8 | Dialysis apheresis unit, Therapeutic | Intended to filtrate the blood and separate the plasma, and extract specific substances in the plasma (e.g., LDL-cholesterol). Then, the plasma is passed through the filtration column in the device and the specific substances that are combined with various substrates are extracted. | C |
| 9 | Disposable Hemoperfusion Cartridge | Intended in hemoperfusion machine to thoroughly remove the endogenous and exogenous materials such as residual drugs, toxins and metabolicsubstances in patients by means of adsorption of synthetic resin and extracorporeal blood circulation. | C |
| 10 | Electrical conductivity measuring instrument for dialysis fluid | Intended to determine the concentration of dialysis fluid supplied to a dialyzer based on the measurement of electrical conductivity of dialysis fluid (usually it is electrically measured) | C |
| 11 | Flexible fiberoptic nephroscope | Intended for the visual examination of internal structures and treatment of the kidney (eg: renal calculus) by inserting percutaneously into the renal pelvis during nephroscopy. | B |
| 12 | Hemodialyzer reprocessing system | Intended to clean (incl. rinsing, cleaning, testing and record keeping of process) and disinfect haemodialysis dialyzers after each use so that they can be reused. | C |
| 13 | Hemofilters | A filter used in the process of haemofiltration, to allow for the removal of toxins and/or the replacement of electrolytes. | C |
| 14 | Hemodiafiltration system | A device used for blood purification with a hemodia filter. | C |
| 15 | Hemodialysis blood tubing/Extracorporeal systems for blood purification | Sterilized blood tubing intended for hemodialysis (including hemofiltration and hemodiafiltration). | B |
| 16 | Hollow-fibre haemodialysis dialyser | Hollow fiber filter intended to remove impurities/fluid from the blood of a patient via haemodialysis machine. | C |
| 17 | Kidney donor-organ preservation/transport system | A dedicated system designed to support and maintain a donated kidney organ during transport from the donor to the receiver hospital where the organ will be transplanted into the recipient. | C |
| 18 | Kidney stone filter | A filter intended to be placed in the urinary duct to prevent a renal stone from moving from the kidney into the bladder. | C |
| 19 | Laser lithotripsy fibre/suction guide | Intended to function as a channel for insertion of the laser fibre of a laser beam guide (e.g., of a general/multiple surgical laser system) in nephroscope, and for removal of debris (e.g., fluid, calculi fragments) when connected to a vacuum source. | B |
| 20 | Multi-patient dialysis fluid delivery system | Intended to prepare dialysis fluid for hemodialysis using an artificial kidney, capable of supplying dialysis fluid for two or more patients. | C |
| 21 | Peritoneal dialysis catheter adaptor | Intended to connect (devices of different makers and makes devices compatible with each other) a catheter for peritoneal lavage to an external device that manages dialysates. | B |
| 22 | Peritoneal dialysis catheter guidewire | A guidewire used temporarily for correction of the position of a peritoneal dialysis catheter. | B |
| 23 | Peritoneal dialysis dialysate warmer | Intended to heat the dialysate to within one degree, of a kidney patient who is on continuous ambulatory peritoneal dialysis (CAPD), body temperature prior to infusion. | C |
| 24 | Peritoneal dialysis ultraviolet irradiation unit | Intended for ultraviolet irradiation for disinfection of components of peritoneal dialysis transfer tube set. | B |
| 25 | Reverse Osmosis Unit (for dialysis) | Intended to be used with haemodialysis to produce water through reverse osmosis with quality suitable for use with haemodialysis equipment. | C |
| 26 | Rigid nephroscope | Intended for visual examination, diagnosis, and treatment of the kidney, renal pelvis, major calyces, and minor calyces by percutaneously inserting scope into the renal pelvis. | B |
| 27 | Shunt thrombus suction set | A set used to suction a thrombus developing inside an arteriovenous shunt (external shunt) during procedures including hemodialysis. | B |
| 28 | Portable continuous peritoneal perfusate thermal conditioner | A device that heats the peritoneal perfusate before injection into the peritoneal cavity. The perfusate is usually heated through direct contact of the dialysis fluid bag with the radiant heat source. | B |
| 29 | Citric acid haemodialysis system cleaning cartridge | Intended for the in-line preparation of a citric acid solution to clean/disinfect the fluid pathways of the system (remove calcium and magnesium deposits) in combination with a heat disinfection program. | B |
| 30 | Extracorporeal circuit waste bag | Intended to be used for the collection of waste fluids during preparation and processing of an extracorporeal circuit (e.g., haemodialysis, haemofiltration, apheresis, adsorption treatment), including the collection and rinsing of ultrafiltrate fluid which may contain blood components. | B |
| 31 | Haemodialysis Concentrate | Intended to remove metabolic waste from the blood to help maintain physiological blood electrolyte and pH levels while haemodialysis is performed | C |
| 32 | Haemodialysis conductivity standard solution | Intended to calibrate conductivity meters used to test the conductivity of dialysate, dialysate concentrate,and water treatment systems used with haemodialysis delivery systems. | C |
| 33 | Haemodialysis dialysate water chlorine test kit/strip | Intended to be used to rapidly indicate, through colour change, the concentration of total chlorine in water used to prepare dialysate solution for haemodialysis. | B |
| 34 | Haemodialysis system air/foam detector | Intended to identify air bubbles and/or foam in blood returned to the body [usually through an arteriovenous fistula (AVF)] by the extracorporeal blood circuit of a haemodialysis system. | C |
| 35 | Hemodialysis system bicarbonate mixer | Intended to mix two concentrates, A and B, plus water, to the dialysis solution (dialysate) and monitor the mixture. | C |
| 36 | Haemodialysis system central monitor | Device intended to connect with multiple haemodialysis systems in order to aid monitoring several dialysis treatments simultaneously. | C |
| 37 | Haemodialysis system plasma filtration unit | An electrically-powered integral unit of a haemodialysis system that allows for the removal of plasma from the blood and the infusion of an equal amount of plasma replacement solution to the blood. | C |
| 38 | Peritoneal dialysis system dialysate filter | A microporous device used to capture contamination particles of the dialysate before its installation into the peritoneal cavity. | C |
| 39 | Sodium carbonate haemodialysis system cleaning cartridge | Intended to be connected to the fluid circuit of an institutional haemodialysis system for the in-line preparation of a sodium carbonate solution to clean the fluid pathways of the system (remove organic deposits, fats, proteins) in combination with a heat disinfection program. | C |
| 40 | Peritoneal Dialysis Transfer Set | A transfer set is tubing that you use to connect your catheter to the bag of dialysis solution. It consists of tubing, connectors etc. | B |
| 41 | Peritoneal Dialysis Catheter | That allows dialysis fluid to enter the abdominal cavity, dwell inside for a while, and then drain back out again | B |
| 42 | Hemodialysis Catheter (Long Term) | 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 | C |
| 43 | Hemodialysis Catheter | A catheter used for exchanging blood to and from the haemodialysis machine from the patient. | B |
| 44 | Single Needle HemodialysisCatheter/ Blood lines | The single-needle dialysis, in which case only one cannula or a single lumen catheter is used to access the blood. | B |
Conclusion:
The above article is taken from S.O 648(E) & G.S.R 102(E) which mentions that all Medical Devices will be regulated in a phase manner. The CDSCO has classified the MDR in India as Appendix A based on the Intended Use, Risks Associated and Other Parameters Specified with the device. The above table has the general intended use against each device, however if any specific intended use for a particular device, it has to be mentioned by the manufacturer. The list is dynamic and is subject to changes. To obtain MDR in India, contact Morulaa. We at Morulaa will help you understand the latest rules for Urology as a Medical Device India. We are a turnkey solution provider with an in-house Medical Device Consultancy team to conduct registrations of Medical Devices in India. In order to comply with the 30th September of Urology as a Medical Device in India contact us at admin@morulaa.com. You can also subscribe to our website to learn about the Latest Rules and Medical Regulations.
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