IVD classification in India decides almost everything about your path to market: which authority licenses you, which documents you file, and whether you need a clinical performance evaluation in India. Under the Medical Devices Rules, 2017, CDSCO places every in vitro diagnostic into one of four risk classes, A to D, based on its intended use.
Key takeaways
- India has four IVD risk classes: A (low), B (low-moderate), C (moderate-high) and D (high).
- Class depends on intended use, not on how the product is classified in the EU or US.
- Class A/B manufacturing licences come from the State Licensing Authority; Class C/D and all imports are licensed by CDSCO.
- Licensing has been mandatory since 1 October 2022 (Class A/B) and 1 October 2023 (Class C/D).
- If several rules apply, the higher class wins. Unlisted IVDs can now be classified through CDSCO’s online system.
Why IVD Classification Matters in India
Your risk class is the first decision in any Indian IVD submission. It determines the licensing authority, the depth of the dossier, the fees, and the inspection approach. Getting it wrong means filing the wrong form, and CDSCO returns the application.
| Risk class | Manufacturing licence | Import licence | Licensing mandatory from |
|---|---|---|---|
| Class A (low) | State Licensing Authority | CDSCO | 1 October 2022 |
| Class B (low-moderate) | State Licensing Authority | CDSCO | 1 October 2022 |
| Class C (moderate-high) | CDSCO | CDSCO | 1 October 2023 |
| Class D (high) | CDSCO | CDSCO | 1 October 2023 |
New Class B, C and D IVDs also need a clinical performance evaluation in India, even if they are already approved in the EU, UK, USA, Canada, Australia or Japan. See our IVD registration in India guide for the full licensing route and forms.
The Four IVD Risk Classes Explained
The Medical Devices Rules, 2017 classify IVDs by the risk to the patient and to public health if the test gives a wrong result. The table below summarises the classification criteria, as set out in the First Schedule and the Indian Pharmacopoeia Commission’s guidance, with examples from CDSCO’s published IVD classification list.
| Class | Risk | Typical criteria | Examples from CDSCO’s list |
|---|---|---|---|
| D | High | Screening blood, cells, tissues or organs for transmissible agents before transfusion or transplant; detecting transmissible agents that cause life-threatening disease with high risk of spread; blood grouping in the ABO, Rhesus, Kell, Kidd and Duffy systems | Blood-screening assays; near-patient ABO/Rh(D) blood grouping analysers |
| C | Moderate-high | Sexually transmitted agents; infectious agents in blood or CSF with limited spread; cancer diagnosis and staging; human genetic testing; prenatal immune status; therapeutic drug monitoring; most self-tests; near-patient blood gas and glucose | PSA, CA125, CEA; ToRCH panels; PT, APTT, D-dimer; troponin and CRP near-patient tests; COVID-19 IVDs; DNA/RNA extraction kits |
| B | Low-moderate | Self-tests whose results are preliminary or not used for critical decisions; controls without assigned values; any IVD not covered by the other rules | Clinical chemistry reagents (glucose, lipids, enzymes); urinalysis strips; preliminary self-test kits such as hCG; CK-MB and myoglobin |
| A | Low | Instruments intended for IVD procedures; specimen receptacles; general reagents for a specific examination | Biochemistry analysers; centrifuges and micropipettes; blood collection tubes; viral transport medium |
Examples are taken from CDSCO’s IVD classification list. The list states an intended use for each item as guidance; your own intended use can change the class, so always check it against your labelling.
How to Determine Your IVD’s Class: 5 Steps
- Define the intended use precisely. What does the test detect, in which specimen, for whom, and for what clinical decision? Classification follows the manufacturer’s stated intended purpose.
- Search CDSCO’s IVD classification list. Find your analyte or device category in the published list and note the class.
- Check every rule that could apply. A blood-grouping reagent, for example, is Class D for ABO and Rh, but Class C for other antigens.
- Apply the highest class. If more than one rule applies, the stricter rule giving the higher class governs.
- Not listed? Request a classification. Since February 2026, unlisted IVDs can be classified through CDSCO’s online system before you file your licence application.
Special Rules That Catch Applicants Out
- Software follows the device. Software that drives or influences an IVD takes the same class as that IVD. Standalone interpretive software is classified on its own.
- Accessories are classified separately from the device they support, including companion IVDs.
- Calibrators follow their reagent’s class, while controls without an assigned value are Class B.
- Near-patient versions can be higher. CDSCO lists a laboratory blood gas analyser as Class A, but the near-patient version as Class C.
- Multiparameter devices. A device combining in-vivo measurements (such as ECG or SpO₂) with in-vitro tests (such as glucose) is regulated as a medical device, not an IVD, according to CDSCO’s March 2026 FAQ addendum.
IVD Grouping in India: Single, Family, Cluster, Test Kit and System
Grouping is separate from classification, but it is decided at the same time. It determines how many fees you pay and whether products can share one Device Master File. The categories come from CDSCO’s grouping guidance.
| Grouping category | Key criteria | Effect on your application |
|---|---|---|
| Single IVD | A distinct packaged product that fits no other category | Separate fee and documents for each product |
| IVD Family | Same licence holder, same risk class, common intended use, same design and manufacturing process | One fee and one common Device Master File |
| IVD Cluster | Same licence holder, common methodology, single proprietary name, compatible as a test kit | Separate fee per product, one common Device Master File |
| IVD Test Kit | Reagents and articles used together for one purpose under one kit name (instruments excluded) | One fee if sold only as a kit; otherwise per constituent |
| IVD System | Components used together for one purpose under one system name | One fee if sold only as a system; otherwise per component |
Up to 15 products can go in one import or manufacturing application, and more can be added later by endorsement.
Common IVD Classification Mistakes
- Copying the EU or US class. India’s list and rules are its own; an IVDR Class B product may sit in a different Indian class.
- Writing a vague intended use. Broad claims such as “screening and diagnosis” can push a product into a higher class than you need.
- Ignoring the near-patient distinction. The same analyte can be Class B in the lab and Class C at the point of care.
- Filing before confirming the class of an unlisted product. Use the online classification request first to avoid a rejected application.
Need your IVD classified correctly first time?
Shen Clinical Services confirms your risk class, grouping and licence route, and files your application with CDSCO, including requests for unlisted IVDs. See our IVD registration services or medical device registration.
Frequently Asked Questions
How many risk classes are there for IVDs in India?
Four. Under Rule 4(2) of the Medical Devices Rules, 2017, IVDs are Class A (low risk), Class B (low-moderate risk), Class C (moderate-high risk) or Class D (high risk).
Who decides the class of an IVD in India?
The Central Licensing Authority (CDSCO) classifies IVDs based on intended use and the parameters in the First Schedule of the Medical Devices Rules, 2017, and publishes a class-wise list on its website.
What if my IVD is not on CDSCO’s classification list?
You can request a risk classification through CDSCO’s online system. CDSCO introduced this provision for IVDs in February 2026, and its March 2026 FAQ addendum confirms that unlisted IVDs can be classified this way.
Is my IVD’s class the same as in the EU or US?
Not necessarily. India uses its own four-class system and its own classification list. A product’s EU or US class does not decide its Indian class, so always check the CDSCO list or request a classification.
Does the class change who issues my licence?
Yes. Manufacturing licences for Class A and B IVDs come from the State Licensing Authority; Class C and D from CDSCO. Import licences for all classes are issued by CDSCO.
Sources: CDSCO In Vitro Diagnostics; CDSCO IVD classification list; CDSCO grouping FAQ; CDSCO IVD FAQ (2022); CDSCO IVD FAQ Addendum, 13 March 2026; Indian Pharmacopoeia Commission guidance document for medical devices. General regulatory information, not legal advice. Always confirm against current CDSCO notifications.