The Indian Council of Medical Research (ICMR) and the Central Drugs Standard Control Organization (CDSCO) have released a draft standard evaluation protocol for In-Vitro Diagnostics (IVDs) and are inviting comments from stakeholders. This public notice was issued on January 29, 2025.
This initiative aims to establish a standardized process for evaluating the quality and performance of IVDs, which is crucial for their licensure under the Medical Devices Rules 2017.
Focus on HMPV Real-Time PCR
The first protocol developed by ICMR and CDSCO focuses on the evaluation of Human Metapneumovirus (HMPV) real-time PCR IVD kits. This protocol is now available for public review and comment.
Interested parties are encouraged to submit their feedback on the draft protocol by March 15, 2025. Comments should be sent to ivdevaluation@gmail.com following the specified format.
The ICMR and CDSCO emphasize the importance of this public consultation, noting that changes to the document will be minimal after the deadline.
Background and Purpose
The collaboration between ICMR and CDSCO seeks to ensure the availability of high-quality diagnostic kits in India. The evaluation protocol aims to standardize the process of independently verifying manufacturers’ performance claims for IVDs. The current draft focuses specifically on laboratory performance evaluation of HMPV real-time PCR kits, with all clinical samples tested according to the candidate test’s instructions for use. The primary purpose is to evaluate the performance characteristics of these kits in diagnosing HMPV infection/disease.
Requirements for Evaluation
The protocol outlines several key requirements for the evaluation process, including:
- Supply of kits under evaluation (with batch/lot number, expiry, and other details). If the kit uses a closed system, the manufacturer must provide the necessary equipment.
- Designated evaluation sites/laboratories equipped with the required equipment.
- Reference test kits.
- Characterized evaluation panel.
- Laboratory supplies.
This initiative is a crucial step towards ensuring the quality and reliability of IVD kits used in India. ICMR and CDSCO aim to strengthen the regulatory framework for medical devices and protect public health.
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