In a significant development aimed at strengthening medical device regulation and patient safety, the Central Drugs Standard Control Organization (CDSCO) of India has recently classified in-vitro diagnostic (IVD) medical devices. This classification, conducted under the provisions of the Medical Devices Rules (MDR) – 2017, represents a proactive effort to enhance the safety, quality, and performance of IVD devices used across various clinical domains.
Enhanced Classification for Enhanced Safety
IVD medical devices, pivotal in the world of diagnostics, have been systematically classified into four categories: A (Low risk), B (Low moderate risk), C (Moderate high risk), and D (High risk). This categorization considers several factors, including the intended use of the device and the level of associated risk, all meticulously detailed in the First Schedule of MDR-2017.
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Regulation and Patient Safety
Underlining the importance of this classification, the Drug Controller General of India (DCGI) emphasizes that the safety, quality, and performance of these IVD medical devices fall under the purview of the Drugs and Cosmetics Act-1940 and its subsequent regulations. The CDSCO, as part of its commitment to ensuring safe usage, has specified the general application of these devices, particularly in terms of their import and manufacturing. Meanwhile, the manufacturer’s instructions detail their specific use.
This classification has profound implications as it guarantees that IVD medical devices are used securely and efficiently within the healthcare system, benefiting both patients and healthcare providers.
Crucially, the list of classified IVD devices is dynamic, subject to regular revisions under the provisions of the Medical Devices Rules (MDR) – 2017. This forward-thinking approach ensures that the regulatory framework remains up to date with advancements in medical technology and the ever-evolving needs of patients.
You can also Read our blog on In Vitro Diagnostic Medical Devices Regulations for more information.
CDSCO's Commitment to Excellence
The CDSCO’s proactive measures to enhance the regulation of IVD medical devices underscore its unwavering commitment to ensuring the highest standards of safety, quality, and performance within the Indian healthcare system. This classification not only offers a regulatory framework but also provides valuable guidance to manufacturers and importers, ultimately contributing to the well-being of patients across the country.
For Expert Guidance on India's New IVD Device Classification.
For further information and a detailed list of the classified In-vitro Diagnostic Medical Devices, please refer to the Annexures provided by CDSCO. Stay informed and help maintain the highest standards of patient safety and healthcare quality. If you want to explore the full implications of this groundbreaking IVD device classification and its impact on the healthcare industry, contact Operon Strategist today. Our experts are ready to provide in-depth insights and guidance on how this development can shape your strategies, ensuring you stay ahead in the ever-evolving healthcare landscape. Don’t miss this opportunity to make informed decisions in the dynamic healthcare sector—Contact us now.
