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CDSCO Releases Draft Guidelines for IVD Medical Devices

Written by : Aishwarya Sarthe

April 29, 2024

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This document aims to assist manufacturers in preparing premarket review documents for import or manufacturing licenses, potentially impacting the quality and reliability of healthcare diagnostic devices.

The Central Drugs Standard Control Organisation (CDSCO) has released a draft guidance document on stability studies concerning In-vitro Diagnostic Medical Devices (IVDMD).

According to the drug regulator, adherence to this guidance is essential for manufacturers submitting applications for premarket licensing and post-approval changes.

Aimed at aiding manufacturers in preparing premarket review documents for import or manufacturing license applications, this document is poised to have a notable impact on the quality and reliability of diagnostic devices in the healthcare sector.

Highlights from the Revised Draft

The draft guidance document, unveiled earlier this month, is designed to assist manufacturers in providing scientific information. 

Which is required to support claimed shelf life, in-use stability, and shipping studies for IVDMD license applications and post-approval change applications under the Medical Devices Rules (MDR), 2017. 

Stability is a crucial factor affecting IVD reagent performance, directly impacting patient results. However, the responsibility lies with the manufacturer to determine and monitor the stability of IVD products to ensure consistent performance characteristics. 

The guidance document addresses stability evaluation for various components of in vitro diagnostic medical devices, excluding IVD analyzers, instruments, apparatus, equipment, software, and systems.

"Stability testing should be performed on at least three different lots manufactured under conditions equivalent to routine production conditions. Accelerated studies or extrapolated data from real-time data are acceptable for initial shelf life claims but must be followed up with real-time stability studies," stated a representative from CDSCO.

Furthermore, the document provides detailed instructions for conducting in-use stability and shipping stability studies, emphasizing the importance of reflecting real-world usage.

It also talks about anticipated shipping conditions, including temperature extremes, humidity, and other environmental factors encountered during transportation and storage.

CDSCO’s Recommendations

In line with ensuring the highest standards of quality and reliability, the CDSCO has recommended the adoption of the latest standards, such as IS/ISO 23640, CLSI-EP25-A, ASTM4169-14, and WHO TGS2, for establishing stability claims for IVD medical devices. Manufacturers are urged to familiarize themselves with these standards and incorporate them into their stability studies.

"Manufacturers must adhere to the recommended standards when designing and planning their stability studies," stated the CDSCO representative.

Stability studies are pivotal in developing and maintaining IVDs, ensuring that predetermined user expectations are met and quality problems are preempted. 

Establishing product stability claims involves defining stability, developing testing protocols, executing the plan, and deriving stability claims from analyzing experimental data.

"A well-designed stability study must provide evidence of the stability of critical constituents, claimed analytes, and performance levels of the IVD," highlighted the representative. 

Recent Regulatory Framework  Developments

In a recent move towards enhancing the regulatory framework, the CDSCO unveiled a revised Guidance for Industry Version 1.2 draft to streamline clinical trial applications and new drug approvals. 

Aligned with the NDCT Rules 2019 and the Sugam application process, this initiative underscores India's commitment to evolving pharmaceutical regulation standards.

The draft guidance addresses key aspects related to submitting clinical trial applications, requirements for new drug approvals, and preparing quality information for drug submissions, focusing on biotechnological and biological products.

The release of the draft guidance document on stability studies by the CDSCO marks a significant milestone in ensuring the quality, reliability, and regulatory compliance of In-vitro Diagnostic Medical Devices. 


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