This notice from the Drugs Controller General (India) provides a classification of various medical devices pertaining to Nephrology and Renal Care based on their intended use and associated risk.
Key Changes
The notice classifies 44 medical devices used in nephrology and renal care.
The classification is based on risk, with devices categorized as Class A, B, C, or D, with D being the highest risk.
Examples of Class A devices include 'Chair, Haemodialysis, Electrically powered/Manual' and 'Crimp for plier, Haemodialysis'.
Examples of Class B devices include 'Urinary stone retrieval basket', 'Flexible fibreoptic nephroscope', 'Hemodialysis blood tubing/Extracorporeal systems for blood purification', 'Laser lithotripsy fibre/suction guide', 'Peritoneal dialysis catheter adaptor', 'Peritoneal dialysis catheter guidewire', 'Peritoneal dialysis ultraviolet irradiation unit', 'Rigid nephroscope', 'Shunt thrombus suction set', 'Portable continuous peritoneal perfusate thermal conditioner', 'Citric acid haemodialysis system cleaning system cartridge', 'Extracorporeal circuit waste bag', 'Haemodialysis dialysate water chlorine test kit/strip', 'Peritoneal Dialysis Transfer Set', 'Peritoneal Dialysis Catheter', 'Hemodialysis Catheter', 'Single Needle Hemodialysis Catheter/ Blood lines',
Examples of Class C devices include 'Automated peritoneal dialysis system', 'Dialysis apheresis unit, Therapeutic', 'Disposable Hemoperfusion Cartridge', 'Electrical conductivity measuring instrument for dialysis fluid', 'Haemodialyzer reprocessing system', 'Haemofilters', 'Hemodiafiltration system', 'Hollow-fibre haemodialysis dialyser', 'Kidney donor-organ preservation/transport system', 'Kidney stone filter', 'Multi-patient dialysis fluid delivery system', 'Peritoneal dialysis dialysate warmer', 'Reverse Osmosis Unit (for dialysis)', 'Haemodialysis Concentrate', 'Haemodialysis conductivity standard', 'Haemodialysis system air/foam detector', 'Hemodialysis system bicarbonate mixer', 'Haemodialysis system central monitor', 'Haemodialysis system plasma filtration unit', 'Peritoneal dialysis system dialysate filter', 'Sodium carbonate haemodialysis system cleaning cartridge', 'Hemodialysis Catheter (Long Term)'.
Examples of Class D devices include 'Absorbable peritoneum catheter cuff' and 'Collagen-containing peritoneum absorbable catheter cuff'.
Impact Analysis
Manufacturers and Importers
Action Item: Review product portfolio and classify devices according to this notification. Prepare for necessary regulatory submissions based on the assigned class.
Healthcare Providers
Action Item: Update procurement and usage protocols to reflect the risk classification of these devices.
Patients
Action Item: No direct action required, but patients should be informed about the types of devices used in their treatment and their associated risks.
Regulatory Bodies
Action Item: CDSCO to implement this classification in its regulatory processes and communicate requirements to stakeholders.
Key Entities Referenced
Drugs Controller General (India): The regulatory authority responsible for medical devices in India.
Central Drugs Standard Control Organisation (CDSCO): The national regulatory body for pharmaceuticals and medical devices in India.
Medical Devices: A wide range of instruments, apparatus, implements, machines, appliances, implants, reagents for in vitro use and software that are intended to be used for human beings or animals for diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder.
Appendix A
File No. 29/Misc./03/2020-DC (143)
Drugs Controller General (India)
Directorate General of Health Services
Central Drugs Standard Control Organisation
FDA Bhawan, Kotla Road, New Delhi
NOTICE
Classification of Medical devices pertaining to Nephrology and Renal Care
S. Medical Device Risk
Intended Use
No. Name Class
Intended to maintain stable contact between the skin
Absorbable and the peritoneal dialysis catheter, and prevents
1 peritoneum catheter bacterial invasion from the outlet. It is embedded D
cuff subcutaneously at the outlet of the peritoneal dialysis
catheter.
Automated peritoneal An active medical devices intended to perform
2 C
dialysis system peritoneal dialysis.
Urinary stone Intended to remove urinary stones (renal calculi) from
3 B
retrieval basket the body during an endoscopic procedure.
Chair, Haemodialysis, Intended to support the patient in a seated or reclined
4 Electrically posture during haemodialysis procedures. A
powered/Manual.
Collagen-containing A cuff that consists of biodegradable porous material
peritoneum containing collagen, intended to be embedded
5 D
absorbable catheter subcutaneously at the outlet of the peritoneal dialysis
cuff catheter.
Crimp for plier, Intended to manipulate the arteriovenous shunt of
6 A
Haemodialysis patients required hemodialysis.
Intended to connect between a dialysis fluid circuit and
7 Dialyser connector B
dialyzer, etc.
Intended to filtrates the blood and separates the
plasma, and extracts specific substances in the
Dialysis apheresis plasma (e.g., LDL-cholesterol). Then, the plasma is
8 C
unit, Therapeutic passed through the filtration column in the device and
the specific substances that are combined with various
substrates are extracted.
Intended in hemoperfusion machine to thoroughly
Disposable remove the endogenous and exogenous materials
9 Hemoperfusion such as residual drugs, toxins and metabolic C
Cartridge substances in patients by means of adsorption of
synthetic resin and extracorporeal blood circulation.
Intended to determine the concentration of dialysis
Electrical conductivity
fluid supplied to a dialyzer based on the measurement
10 measuring instrument C
of electrical conductivity of dialysis fluid (usually it is
for dialysis fluid
electrically measured)
Intended for the visual examination of internal
Flexible fibreoptic structures and treatment of the kidney (eg: renal
11 B
nephroscope calcus) by inserting percutaneously into the renal
pelvis during nephroscopy.
1 of 4Intended to clean (incl. rinsing, cleaning, testing and
Haemodialyzer record keeping of process) and disinfect
12 C
reprocessing system haemodialysis dialyzers after each use so that they
can be reused.
A filter used in the process of haemofiltration, to allow
13 Haemofilters for the removal of toxins and/or the replacement of C
electrolytes.
Hemodiafiltration A device used for blood purification with a
14 C
system hemodiafilter.
Hemodialysis blood Sterilized blood tubing intended for hemodialysis
tubing/Extracorporeal (including hemofiltration and hemodiafiltration).
15 B
systems for blood
purification
Hollow-fibre Hollow fiber filter intended to remove impurities/fluid
16 haemodialysis from the blood of a patient via haemodialysis machine. C
dialyser
A dedicated system designed to support and maintain
Kidney donor-organ
a donated kidney organ during transport from the
17 preservation/transport C
donor to the receiver hospital where the organ will be
system
transplanted into the recipient.
A filter intended to be placed in the urinary duct to
18 Kidney stone filter prevent a renal stone from moving from the kidney into C
the bladder.
Intended to function as a channel for insertion of the
laser fibre of a laser beam guide (e.g., of a
Laser lithotripsy general/multiple surgical laser system) in
19 B
fibre/suction guide nephroscope, and for removal of debris (e.g., fluid,
calculi fragments) when connected to a vacuum
source.
Intended to prepares dialysis fluid for hemodialysis
Multi-patient dialysis
20 using an artificial kidney, capable of supplying dialysis C
fluid delivery system
fluid for two or more patients.
Intended to connect (devices of different makers and
Peritoneal dialysis makes devices compatible with each other) a catheter
21 B
catheter adaptor for peritoneal lavage to an external device that
manages dialysates.
A guidewire used temporarily for correction of the
Peritoneal dialysis
22 B
position of a peritoneal dialysis catheter.
catheter guidewire
Intended to heat the dialysate to within on degree, of
Peritoneal dialysis kidney patient who is on continuous ambulatory
23 C
dialysate warmer peritoneal dialysis (CAPD), body temperature prior to
infusion.
Peritoneal dialysis intended for ultraviolet irradiation for disinfection of
24 ultraviolet irradiation components of peritoneal dialysis transfer tube set. B
unit
Reverse Osmosis Intended to be used with haemodialysis to produce
Unit (for dialysis) water through reverse osmosis with quality suitable for
25 C
use with haemodialysis equipment.
Page 2 of 4Intended for visual examination, diagnosis, and
treatment of the kidney, renal pelvis, major calyces,
26 Rigid nephroscope B
and minor calyces by percutaneously inserting scope
into the renal pelvis.
A set used to suction a thrombus developing inside an
Shunt thrombus
27 arteriovenous shunt (external shunt) during B
suction set
procedures including hemodialysis.
A device that heats the peritoneal perfusate before
Portable continuous
injection into the peritoneal cavity. The perfusate is
28 peritoneal perfusate B
usually heated through direct contact of the dialysis
thermal conditioner
fluid bag with the radiant heat source.
Citric acid Intended for the in-line preparation of a citric acid
haemodialysis solution to clean/disinfect the fluid pathways of the
29 B
system cleaning system (remove calcium and magnesium deposits) in
cartridge combination with a heat disinfection program.
Intended to be used for the collection of waste fluids
during preparation and processing of an
Extracorporeal circuit extracorporeal circuit (e.g., haemodialysis,
30 B
waste bag haemofiltration, apheresis, adsorption treatment),
including the collection and rinsing of ultrafiltrate fluid
which may contain blood components.
Intended to remove metabolic waste from the blood to
Haemodialysis
31 help maintain physiological blood electrolyte and pH C
Concentrate
levels while haemodialysis is performed
Intended to calibrate conductivity meters used to test
Haemodialysis
the conductivity of dialysate, dialysate concentrate,
32 conductivity standard C
and water treatment systems used with haemodialysis
solution
delivery systems.
Intended to be used to rapidly indicate, through colour
Haemodialysis
change, the concentration of total chlorine in water
33 dialysate water B
used to prepare dialysate solution for haemodialysis.
chlorine test kit/strip
Intended to identify air bubbles and/or foam in blood
Haemodialysis
returned to the body [usually through an arteriovenous
34 system air/foam C
fistula (AVF)] by the extracorporeal blood circuit of a
detector
haemodialysis system.
Intended to mixes two concentrates, A and B, plus
Hemodialysis system
35 water, to the dialysis solution (dialysate) and monitors C
bicarbonate mixer
the mixture.
Haemodialysis Device intended to connect with multiple
36 system central haemodialysis systems in order to aid monitoring C
monitor several dialysis treatments simultaneously.
An electrically-powered integral unit of a
Haemodialysis
haemodialysis system that allows for the removal of
37 system plasma C
plasma from the blood and the infusion of an equal
filtration unit
amount of plasma replacement solution to the blood.
A microporous device used to capture contamination
Peritoneal dialysis
38 particles of the dialysate before its instillation into the C
system dialysate filter
peritoneal cavity.
Page 3 of 4Intended to be connected to the fluid circuit of an
Sodium carbonate institutional haemodialysis system for the in-line
haemodialysis preparation of a sodium carbonate solution to clean
39 C
system cleaning the fluid pathways of the system (remove organic
cartridge deposits, fats, proteins) in combination with a heat
disinfection program.
A transfer set is tubing that you use to connect your
Peritoneal Dialysis
40 catheter to the bag of dialysis solution. It consists of B
Transfer Set
tubing, connectors etc.
That allows dialysis fluid to enter the abdominal cavity,
Peritoneal Dialysis
41 dwell inside for a while, and then drain back out again B
Catheter
A dialysis catheter is a catheter used for exchanging
Hemodialysis blood to and from the hemodialysis machine from the
42 C
Catheter (Long Term) patient. The dialysis catheter contains two lumens:
Venous. Arterial
A catheter used for exchanging blood to and from the
Hemodialysis
43 haemodialysis machine from the patient. B
Catheter
Single Needle The single-needle dialysis, in which case only one
44 Hemodialysis cannula or a single lumen catheter is used to access B
Catheter/ Blood lines the blood.
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