Medical Device Regulations Alert

CDSCO Draft Guidelines for Performance Evaluation of IVDs

The draft guidelines for the Performance Evaluation of In-Vitro Diagnostics (IVDs) have been issued by the Indian Council of Medical Research (ICMR) and the Central Drugs Standard Control Organisation (CDSCO).

Narrative and Purpose:

The purpose of these draft protocols is to standardize the evaluation process for IVD kits in India. This is part of an effort to align with the Medical Devices Rules, 2017, which mandates detailed performance evaluation for the licensure of IVDs. The guidelines aim to ensure the reliability and quality of diagnostic kits used to detect various infectious diseases. They establish a uniform process for performance evaluation to independently verify a manufacturer’s claims regarding the IVD’s performance.

Licensure of In-Vitro Diagnostics (IVDs) under Medical Devices Rules 2017 requires a detailed evaluation protocol for the performance evaluation of IVDs to evaluate their quality and performance. To facilitate this process, the Indian Council of Medical Research (ICMR) and CDSCO have come together to draft standard evaluation protocols for use by IVD manufacturers testing labs in India.

Intended for:

The guidelines are intended for use by IVD manufacturers and testing laboratories in India.

What the guideline document contains:

The document outlines standard evaluation and field evaluation protocols for various IVDs. This includes tests for infectious diseases such as:

• Dengue
• Malaria
• Chikungunya
• Zika virus
• Influenza
• SARS-CoV-2
• Human Metapneumovirus (HMPV)

Currently, the following IVD evaluation protocols have been developed by ICMR and CDSCO:

1. Performance evaluation protocol for Influenza virus molecular detection and/or differentiation assay (single plex/multiplex format)
2. Performance evaluation protocol for SARS-CoV-2 molecular detection assay (single plex/multiplex format)
3. Performance evaluation protocol for Respiratory Syncytial Virus molecular detection assay (single plex/multiplex format)
4. Performance evaluation protocol for Influenza virus and SARS-CoV-2 molecular detection differentiation assay (multiplex format)
5. Performance evaluation protocol for Influenza virus,SARS-CoV-2 and RSV molecular detection and differentiation assay (multiplex format)
6. Performance evaluation protocol for Malaria rapid diagnostic test (RDT) for P falciparum and/or P vivax
7. Performance evaluation protocol for Malaria ELISA assay
8. Performance evaluation protocol for Malaria real time PCR assay
9. Field evaluation protocol for combo Malaria Rapid Diagnostic Test (RDT) kits (detecting P vivax and P falciparum)
10. Performance evaluation protocol for Nipah virus Real Time PCR
11. Performance evaluation protocol for Chandipura virus Real Time PCR
12. Performanceevaluationprotocolformultiplexrespiratoryvirus(expandedpanel)Real Time PCR
13. Performance evaluation protocol for Dengue IgG RDT
14. Performance evaluation protocol for Dengue IgM/IgG Combo RDT
15. Performance evaluation protocol for Dengue IgG ELISA

The document also includes protocols for other diseases, each with its own table of contents.

Dengue IgG Based Assays Performance Evaluation Protocols : Includes protocols for Dengue IgG RDT kits, Dengue IgM and IgG RDT combo kits, and Dengue IgG ELISA kits.

Malaria IVD Performance Evaluation Protocols : Includes protocols for Malaria RDT kits, ELISA kits, real-time PCR kits, and a field evaluation protocol for combo RDT kits.

Nipah Virus Real Time PCR Kit Performance Evaluation Protocol.

Chandipura Virus Real Time PCR Kit Performance Evaluation Protocol.

Multiplex Respiratory Virus Real Time PCR Kit Performance Evaluation Protocol.

Key Sections and Contents

The documents cover several key areas related to IVD evaluation. The primary goal is to provide a standardized approach for manufacturers and testing labs to demonstrate that their products meet necessary benchmarks for quality, safety, sensitivity, and specificity.

The content of these document includes the following:

Annexures: The document includes annexures with additional information, such as templates for stakeholder feedback

Introduction and Definitions: The documents begin by defining key terms like In-Vitro Diagnostic (IVD) medical device, performance evaluation, and clinical performance evaluation, providing the regulatory context under the Medical Devices Rules, 2017.

Performance Evaluation Protocols: Specific, detailed protocols are provided for the evaluation of IVDs for various diseases. For example, a single document (ICMR-CDSCO/IVD/GD/PROTOCOLS/01/2024) outlines protocols for 14 different tests related to Dengue, Chikungunya, and Zika viruses. Another document (ICMR-CDSCO/IVD/GD/PROTOCOLS/06/2025) covers protocols for respiratory viruses and malaria. The protocols specify how to perform both laboratory-based performance evaluation and, where applicable, field evaluation.

Requirements for Manufacturers: The guidelines detail the requirements for manufacturers, including the submission of a performance evaluation report. This report should include data on clinical and analytical performance to support the product’s intended use and claims.

Stability Studies: One of the documents, “Guidance on Stability Studies of In-vitro Diagnostic Medical Device (IVDMD),” provides a detailed table of contents on how to conduct stability studies to determine a product’s shelf life, in-use stability, and shipping stability.

Roles of Stakeholders: The documents also clarify the roles of various stakeholders, including regulatory authorities, manufacturers, and testing laboratories, in the performance evaluation process.

These protocols are now being placed in the public domain for comments from relevant stakeholders.

Who should offer comments:

Comments and feedback are being sought from relevant stakeholders.

Last cut-off date for submission:

The search results show multiple draft guidelines with different deadlines for public comments:

• August 25, 2025

Contact email ID for submission:

Stakeholders are requested to submit their comments via email to: ivdevaluation@gmail.com

Download the Draft Guidance document on Performance Evaluation released by CDSCO from here