CDSCO Registration for In Vitro Diagnostic (IVD) Devices in India (2026): Classification, Licensing & New Risk Rules

The Central Drugs Standard Control Organisation (CDSCO) — India's national regulatory authority for medical devices, operating under the Directorate General of Health Services, Ministry of Health & Family Welfare — regulates In Vitro Diagnostic (IVD) devices as a distinct category under the Medical Devices Rules, 2017 (MDR 2017). IVDs — reagents, instruments, and software used to test human specimens outside the body, from rapid antigen tests and glucose strips to molecular diagnostics and next-generation sequencing platforms — follow their own classification track under Part II of the First Schedule of MDR 2017, separate from general medical devices.

Two changes make 2026 a pivotal year for IVD manufacturers and importers: CDSCO directed State Licensing Authorities in October 2025 that no IVD licence can be issued for an unclassified device, and a dedicated online provision for submitting IVD risk classification applications went live on 18 February 2026. This guide explains how IVD classification and registration actually work, what's changed, and where applicants most often run into delays. For the broader classification framework IVDs sit alongside, see our CDSCO registration guide for Class A medical devices.

What is an IVD device, and how does CDSCO regulate it?

An In Vitro Diagnostic (IVD) device is a reagent, instrument, software, or kit used to examine specimens taken from the human body — blood, urine, tissue, or other samples — to diagnose disease, monitor treatment, or assess health status, and CDSCO requires a valid licence before any notified IVD can be manufactured, imported, or sold in India. This covers rapid diagnostic tests, glucose monitoring strips, immunoassay platforms, molecular diagnostic kits, laboratory analysers, and the software used to interpret their results.

IVDs are classified separately from general medical devices under Part II of the First Schedule of MDR 2017, though they follow the same four-tier risk structure — Class A (low individual/public health risk) through Class D (high individual/public health risk, such as tests for transfusion-transmissible infections). The Drugs Controller General of India (DCGI), acting as the Central Licensing Authority (CLA), determines and publishes IVD classification, while State Licensing Authorities (SLAs) handle manufacturing licences specifically for Class A and Class B IVDs; Class C and D manufacturing, along with all import licensing, is handled centrally by the CLA.

This applies to domestic diagnostic kit manufacturers, laboratory equipment companies, hospital-lab suppliers, and any overseas IVD manufacturer exporting into India, regardless of where the underlying research or manufacturing takes place. A company distributing an IVD it doesn't manufacture — reselling an imported rapid test kit domestically, for instance — is still bound by the same classification and licensing requirements as the original manufacturer, since the obligation attaches to the product entering the Indian market, not solely to whoever produced it.

Additional requirements for foreign IVD manufacturers

Foreign IVD manufacturers must appoint an Indian Authorised Agent (IAA) before an import licence application can be filed, and cannot rely on classification or approval from another market as a substitute for CDSCO's own classification and licensing process. The IAA holds the import licence on the manufacturer's behalf and manages correspondence with the CLA throughout the review, including responding to any performance-data or documentation queries.

Existing performance data generated for EU IVDR CE marking or US FDA clearance can support a CDSCO submission — particularly for analytical performance parameters that don't vary meaningfully by population — but Indian reviewers may still expect population-specific validation data for certain Class C and D assays, especially infectious-disease tests where prevalence and strain variation differ from the markets where the original data was generated. Foreign manufacturers planning an India launch should build this potential gap into their timeline rather than assuming existing international dossiers will transfer without modification.

How does IVD classification affect documentation requirements?

IVD risk class directly determines how much clinical and performance evidence a manufacturer must submit — Class A and B devices generally need a concise summary of study protocols and results, while Class C and D devices require full study protocols, detailed data analysis methods, and substantiated conclusions. This scaling matters in practice: a manufacturer preparing a Class A glucose test strip dossier and a manufacturer preparing a Class D infectious-disease screening assay are working from the same regulatory framework but facing very different documentation burdens.

Risk class	Example IVD	Licensing authority
Class A	General lab reagents, low-risk self-test kits	State Licensing Authority (SLA)
Class B	Pregnancy tests, cholesterol monitoring kits	State Licensing Authority (SLA)
Class C	HbA1c assays, tumour marker tests	Central Licensing Authority (CLA/DCGI)
Class D	HIV, Hepatitis B/C, and other transfusion-transmissible infection tests	Central Licensing Authority (CLA/DCGI)

Many modern IVD platforms pair hardware with interpretive software — an analyser paired with a results-interpretation algorithm, for instance — and where that software independently performs a diagnostic function rather than simply operating the hardware, it may need separate consideration as Software as a Medical Device. Our CDSCO guide to SaMD and AI diagnostic tools covers this distinction in more depth.

Documents required for CDSCO IVD registration

A complete IVD application needs classification confirmation, a device master file, and performance evaluation data scaled to the device's risk class.

How to register an IVD device with CDSCO: step-by-step

New IVDs not already on CDSCO's classification list must obtain classification before licensing, then follow the standard MDR 2017 registration pathway.

What does CDSCO registration cost for IVD manufacturers?

CDSCO registration cost for IVDs depends heavily on risk class, since Class C/D devices require substantially more performance evaluation work than Class A/B devices — government fees follow the same MD form structure as general medical devices, but performance evaluation and clinical data generation are usually the larger cost driver. A Class A reagent with a straightforward performance summary costs meaningfully less to bring to market than a Class D infectious-disease assay requiring comprehensive clinical performance studies at an approved laboratory.

Consultant fees, where used, are typically quoted separately and vary based on whether the manufacturer already holds performance data from another market (such as EU IVDR or US FDA clearance) that can support, though not substitute for, the CDSCO dossier. Get a written, itemised quote after a consultant has reviewed your device's likely classification, since two superficially similar IVD products can carry very different validation costs depending on their exact risk class and existing evidence base.

Budgeting should also account for the cost of a classification application itself where a device isn't yet on CDSCO's published list — while the government fee for this step is modest, the technical justification needed to support a specific classification request can require meaningful regulatory-writing effort, particularly for genuinely novel diagnostic technologies without an obvious comparator already on the list. Manufacturers entering India with a portfolio of related IVD products should also ask whether a grouping approach — covered under CDSCO's guidance on grouping of medical devices and IVDs — could consolidate several related tests under fewer licence applications, since this can meaningfully reduce both cost and administrative overhead compared with licensing each variant separately.

Common pitfalls in CDSCO IVD applications

Most CDSCO IVD delays trace back to classification and documentation gaps — filing a licence application before classification is confirmed now carries the highest risk, since SLAs can no longer process it.

Pitfall	Impact	Severity
Filing a licence application before classification is confirmed	SLA cannot process the application under the October 2025 directive	High
Performance data depth mismatched to risk class	Deficiency notice; dossier sent back for additional studies	High
No Indian Authorised Agent for foreign IVD manufacturers	Import licence application cannot proceed	High
Performance evaluation done at a non-approved laboratory	Data rejected; retesting required at an approved lab	Medium
Stability/shelf-life data missing for reagent-based IVDs	Query raised during review; adds weeks to timeline	Medium

How MRDX REGULATORY supports CDSCO registration for IVDs, end-to-end

MRDX REGULATORY provides CDSCO medical device registration support covering classification, device master file preparation, and licensing for IVDs alongside general medical devices and SaMD. If you're comparing consultants for a broader CDSCO project, see our Top 20 CDSCO Licensing Consultants in India roundup.

CDSCO's tightened link between classification and licensing means IVD manufacturers and importers can no longer treat classification as a formality to sort out alongside a licence application — it now has to come first, confirmed and on file, before an SLA or the CLA will process anything further. Whether you're bringing a new rapid diagnostic kit, a laboratory analyser, or a molecular diagnostics platform into India, confirming your IVD's classification early and matching your performance evaluation depth to that risk class is what will keep your registration on a predictable timeline. Foreign manufacturers in particular should build classification confirmation, Indian Authorised Agent appointment, and any population-specific validation gaps into their launch plan from the outset, rather than discovering them mid-review.