[Home](/)/[Resources](/resources)/CDSCO IVD Regulation IndiaCDSCO / IVD # CDSCO Regulation for In-Vitro Diagnostic Devices (IVDs) in India IVDs — from pregnancy test strips to HIV rapid kits to PCR analyzers — are regulated as medical devices under India's Medical Device Rules 2017. The classification system (A through D) determines whether a Notified Body is required and how much performance data CDSCO will ask for. Class D IVDs serving blood safety or infectious disease diagnosis face the most rigorous pathway. Copy Link[Share on WhatsApp](https://wa.me/?text=https%3A%2F%2Fkrono-labs.com%2Fguides%2Fcdsco-ivd-regulation) At a glance IVD classes 4 Required documents 10 Labeling fields 10 ## IVD classification under Medical Device Rules 2017 ### Class A (Low Risk) **Examples:** General laboratory glassware, specimen collection containers, culture media, staining reagents **Approval pathway:** Registration only — no performance evaluation data required from CDSCO Notified Body Notified Body: Not required ### Class B (Low-Moderate Risk) **Examples:** Urine test strips, pregnancy test kits (OTC), blood grouping reagents (non-ABO) **Approval pathway:** Import license from CDSCO required; self-certification with ISO 13485 and performance data Notified Body: Not required for most ### Class C (Moderate-High Risk) **Examples:** Blood glucose monitoring systems, HIV rapid test kits, hepatitis B/C test kits, malaria RDTs **Approval pathway:** CDSCO import license required; clinical performance evaluation data; CDSCO Notified Body assessment for certain products Notified Body: Required for Class C HIV, hepatitis, blood glucose ### Class D (High Risk) **Examples:** NAT (nucleic acid amplification) kits for HIV/HBV/HCV, blood grouping reagents for ABO/Rh, screening for blood donation **Approval pathway:** CDSCO import license required; rigorous performance data; Notified Body assessment mandatory; CDSCO central licensing authority approval Notified Body: Mandatory ## Required documents for CDSCO IVD import license 01Application in Form MD-14 (import of medical devices) through Sugam portal 02Free Sale Certificate or CE marking certificate from country of origin 03ISO 13485 Quality Management System certificate for manufacturer 04Product specification and technical brochure with intended use statement 05Clinical performance evaluation data (sensitivity, specificity, accuracy studies) 06Instructions for use (IFU) in English — complete and final version 07Label artwork showing all required information per Schedule III of Medical Device Rules 2017 08Shelf life and storage condition data with supporting stability studies 09For CDSCO Notified Body review (Class C/D): performance evaluation report from recognized NB 10Undertaking from manufacturer regarding quality standards and adverse event reporting ## IVD label requirements in India Name and address of the manufacturer and Indian importer Product name and model or catalogue number Intended purpose / intended use statement Lot number, batch number, or serial number Manufacturing date and expiry date (or use-by date) Storage conditions (temperature range, humidity, light sensitivity) Safety warnings and contraindications IVD symbol (if CE marked) or equivalent India designation Licence number issued by CDSCO after registration Quantity of contents (number of tests, volume of reagents) ## Frequently asked questions ### Is a CDSCO import license required for all IVD kits imported into India? Yes. Under the Medical Device Rules 2017, all in-vitro diagnostic devices (including test kits, reagents, calibrators, controls, and IVD instruments) require a CDSCO import license before commercial import. The only exceptions are samples imported for testing, evaluation, or exhibition purposes (with prior CDSCO permission). Class A devices have a simplified registration pathway, but the import license requirement applies across all classes. ### How is an IVD 'instrument' (like a biochemistry analyzer) regulated differently from 'reagents'? IVD instruments are regulated as medical devices and require their own CDSCO registration — separate from the reagents/kits used with them. A fully automated biochemistry analyzer is typically Class B or C, while the reagents for specific assays may be in the same or different class. Both the instrument and the reagents require individual CDSCO import licenses. An instrument license does not automatically cover the reagents. ### What performance evaluation data does CDSCO require for Class C IVDs like HIV rapid tests? For Class C IVDs (e.g., HIV rapid test kits), CDSCO requires clinical performance evaluation data demonstrating sensitivity, specificity, and accuracy in the Indian population. Studies must include clinical samples from India or data that is validated as representative of the Indian epidemiological context. Pure CE marking data from European population studies may not be sufficient on its own. CDSCO's Technical Expert Committee may review the data submission. ### Does the COVID-19 rapid test kit experience change how CDSCO approves IVDs? The COVID-19 emergency approvals demonstrated CDSCO's capacity for accelerated review under emergency use authorization (EUA) pathways. Post-pandemic, CDSCO has updated its IVD review timelines and performance data requirements. Products that received EUA must obtain regular CDSCO market authorization for continued commercial sale. The experience has also led to stronger requirements for post-market performance surveillance for rapid diagnostic tests in India. **Disclaimer:** This guide reflects the Medical Device Rules 2017 and current CDSCO requirements. IVD classification and data requirements are subject to CDSCO notifications and guidance documents. Always verify current requirements on the CDSCO Sugam portal before submitting applications. 🇮🇳 India roadmap for your product Every standard, document, and test that applies — free, no account required. See your free roadmap[ Want an expert to take your product through 🇮🇳 India compliance for you? One consultant from Krono's compliance team takes your product from requirements to legal sale, with a fixed quote before any work starts. 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