Regulation/Guidelines

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

  • 27th October, 2021
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.

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 analyserA
C
2)Amino acid analyserA
3)Bilirubinometry analyserA
C
4)Catecholamine analyserA
5)Chemiluminescent immunoassay analyserA
6)Chloride coulometric titration analyserA
7)Cholesterol analyserA
8)Clinical Chemistry analyserA
9)Creatinine analyserA
10)Enzyme analyserA
11)Glycated hemoglobin analyserA
12)High-performance liquid chromatography analyserA
13)Identification and antibiotic susceptibility analyserA
14)Ion-selective analyserA
15)Lactate analyserA
16)Lipid profile analyserA
17)Nitrogen body fluid sample analyserA
18)Protein analyserA
19)Radioimmunoassay analyserA
20)Urine analyserA
C
Hematology
21)ABO/Rh (D) blood grouping analyserA
D
22)Blood cell count analyserA
23)Blood coagulation analyserA
C
24)Blood group/ antibody screening analyserA
25)Co-oximetry analyserB
26)Erythrocyte sedimentation analyserA
27)Flow cytometry analyserA
28)Heparin analyserA
29)Osmotic fragility analyserA
30)Reticulocyte analyserA
31)Blood gas analyserA
C
32)Hemoglobin analyserA
33)Platelet aggregation analyserA
Immunology
34)Densitometry analyserA
35)Enzyme immunoassay (EIA) analyserA
36)Fluorescent immunoassay analyserA
37)Immunology analyserA
38)Immunofluorescent analyserA
39)Microarray analyserA
40)Particle counting immunoassay analyserA
41)Photometric immunoassay analyserA
Microbiology
42)Antimicrobial susceptibility analyserA
43)Blood culture analyserA
44)Gene analyserA
45)Immunoturbidometry analyserA
46)Micro-organism identification analyserA
47)Nucleic acid amplification (PCR) analyserA
48)Yeast/fungi identification analyserA
Clinical chemistry/ Microbiology/ Toxicology
49)Gas chromatography analyserA
Clinical chemistry/ Microbiology/ Hematology
50)Mass spectrometry analyserA
Clinical chemistry/ Immunology
51)Nephelometry immunoassay analyserA
Gastroenterology/ Urology
52)Fecal occult blood immunoassay analyserA
Obstetrical/ Gynecology
53)Spermatozoa /semen analyserA

2) List of IVD instruments

Sr No.Name of Instrument Risk Class 
1)Blood smear cassettes A
2)Blood smear instrumentA
3)Blood tube mixerA
4)Blood component separatorA
5)Blood collection tube A
6)Cell washerA
7)Colony counterA
8)Inoculating loopA
9)Magnetic particle separation instrumentA
10)Microbial incubator/imaging instrumentA
11)Microplate seal rollerA
12)Microplate washerA
13)Microscope slide coverslipperA
14)Microscope slide hybridization/denaturation incubatorA
15)Microscope slide maker/ stainerA
16)Microscope slide washerA
17)Nucleic acid sample preparation instrumentA
18)Side-mounted tissue dissection systemA
19)Specimen processing instrumentA

3) List of IVD software

Sr NoName of IVD SoftwareRisk Class 
1)Cancer cell marker/ morphology image analysis softwareC
2)Cancer risk assessment interpretative software C
3)Cardiovascular risk/probability assessment interpretative softwareC
4)Congenital defect/syndrome risk  assessment interpretative softwareC
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.

References:

  1. InVitro Diagnostics. CDSCO (India). Available from: https://cdsco.gov.in/opencms/opencms/en/Medical-Device-Diagnostics/InVitro-Diagnostics/ {Last accessed: 14 August, 2021}