admin / 27th October, 2021

CDSCO Recently Classified 80 In-Vitro Diagnostic Medical Devices For Regulation And Patient Safety

Regulation/Guidelines

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Summary:

Based on the provisions of the Medical Device Rules (MDR) -2017, the Drug Controller General of India (DCGI) has issued a classification of in-vitro diagnostic (IVD) medical devices used in various clinical fieldson 23 July 2021.

IVD medical devices were classified into four classes: A (Low risk), B (Low moderate risk), C (Moderate high risk), and D (High risk). This classification is based on the intended use, the risk associated with the device, and various other parameters enlisted in the First Schedule of MDR-2017.

The safety, quality, and performance of these IVD medical devices are regulated under the Drugs and Cosmetics Act-1940 and rules thereafter. The general use of the device has been specified by the Central Drugs Standards Control Organization (CDSCO) for applications regarding the import, and manufacture of medical devices whereas the specific use has been stated by the manufacturer.

Below is a summary of the classification of IVD devices under provisions of sub-rule (2) rule of the MDR 2017:

1) List of IVD analysers

Sr No.	IVD Devices	Risk Class
Clinical Chemistry
1)	Alcohol body fluid analyser	A
1)	Alcohol body fluid analyser	C
2)	Amino acid analyser	A
3)	Bilirubinometry analyser	A
3)	Bilirubinometry analyser	C
4)	Catecholamine analyser	A
5)	Chemiluminescent immunoassay analyser	A
6)	Chloride coulometric titration analyser	A
7)	Cholesterol analyser	A
8)	Clinical Chemistry analyser	A
9)	Creatinine analyser	A
10)	Enzyme analyser	A
11)	Glycated hemoglobin analyser	A
12)	High-performance liquid chromatography analyser	A
13)	Identification and antibiotic susceptibility analyser	A
14)	Ion-selective analyser	A
15)	Lactate analyser	A
16)	Lipid profile analyser	A
17)	Nitrogen body fluid sample analyser	A
18)	Protein analyser	A
19)	Radioimmunoassay analyser	A
20)	Urine analyser	A
20)	Urine analyser	C
Hematology
21)	ABO/Rh (D) blood grouping analyser	A
21)	ABO/Rh (D) blood grouping analyser	D
22)	Blood cell count analyser	A
23)	Blood coagulation analyser	A
23)	Blood coagulation analyser	C
24)	Blood group/ antibody screening analyser	A
25)	Co-oximetry analyser	B
26)	Erythrocyte sedimentation analyser	A
27)	Flow cytometry analyser	A
28)	Heparin analyser	A
29)	Osmotic fragility analyser	A
30)	Reticulocyte analyser	A
31)	Blood gas analyser	A
31)	Blood gas analyser	C
32)	Hemoglobin analyser	A
33)	Platelet aggregation analyser	A
Immunology
34)	Densitometry analyser	A
35)	Enzyme immunoassay (EIA) analyser	A
36)	Fluorescent immunoassay analyser	A
37)	Immunology analyser	A
38)	Immunofluorescent analyser	A
39)	Microarray analyser	A
40)	Particle counting immunoassay analyser	A
41)	Photometric immunoassay analyser	A
Microbiology
42)	Antimicrobial susceptibility analyser	A
43)	Blood culture analyser	A
44)	Gene analyser	A
45)	Immunoturbidometry analyser	A
46)	Micro-organism identification analyser	A
47)	Nucleic acid amplification (PCR) analyser	A
48)	Yeast/fungi identification analyser	A
Clinical chemistry/ Microbiology/ Toxicology
49)	Gas chromatography analyser	A
Clinical chemistry/ Microbiology/ Hematology
50)	Mass spectrometry analyser	A
Clinical chemistry/ Immunology
51)	Nephelometry immunoassay analyser	A
Gastroenterology/ Urology
52)	Fecal occult blood immunoassay analyser	A
Obstetrical/ Gynecology
53)	Spermatozoa /semen analyser	A

2) List of IVD instruments

Sr No.	Name of Instrument	Risk Class
1)	Blood smear cassettes	A
2)	Blood smear instrument	A
3)	Blood tube mixer	A
4)	Blood component separator	A
5)	Blood collection tube	A
6)	Cell washer	A
7)	Colony counter	A
8)	Inoculating loop	A
9)	Magnetic particle separation instrument	A
10)	Microbial incubator/imaging instrument	A
11)	Microplate seal roller	A
12)	Microplate washer	A
13)	Microscope slide coverslipper	A
14)	Microscope slide hybridization/denaturation incubator	A
15)	Microscope slide maker/ stainer	A
16)	Microscope slide washer	A
17)	Nucleic acid sample preparation instrument	A
18)	Side-mounted tissue dissection system	A
19)	Specimen processing instrument	A

3) List of IVD software

Sr No	Name of IVD Software	Risk Class
1)	Cancer cell marker/ morphology image analysis software	C
2)	Cancer risk assessment interpretative software	C
3)	Cardiovascular risk/probability assessment interpretative software	C
4)	Congenital defect/syndrome risk assessment interpretative software	C
5)	Human genomic analysis interpretative software	C
6)	Laboratory instrument/analyser application software	A
7)	Microbial identification interpretative software	A
8)	Osteoporosis risk assessment interpretative software	A

This list will help companies in complying with MDR-2017 concerning the import, clinical investigation, manufacture, performance evaluation, sale, and distribution of these IVD medical devices. It should be noted that list is not consistent and is subjected to revisions from time to time.