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Govt to Tighten Safety Norms for Life-Saving Medical Devices

Written by : Jayati Dubey

May 22, 2024

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Key stakeholders, including the Department of Pharmaceuticals, NITI Aayog, and the Union Health Ministry, are involved in the ongoing discussions.

In a significant move, the Central Drugs and Standards Control Organization (CDSCO) and the Bureau of Indian Standards (BIS) are revisiting the benchmarks set for life-saving medical devices in India.

This initiative aims to enhance safety and performance standards, reflecting the rapid technological advancements in medical sciences.

An official confirmed that the Union government is currently evaluating these standards to ensure they meet contemporary safety and performance requirements.

Existing Standards

Currently, India has approximately 1,500 standards for various pharmaceutical items. Of the roughly 6,000 medical devices available in the country, CDSCO has classified around 3,000 based on their usage.

These devices range from electronic equipment and implants to consumables, disposables, surgical instruments, and in-vitro diagnostic reagents.

The new norms aim to establish harmonized regulation within the medical device sector. Key stakeholders, including the Department of Pharmaceuticals, NITI Aayog, and the Union Health Ministry, are involved in ongoing discussions.

The medical device sector in India is emerging rapidly, with an estimated market size of $11 billion in 2020. Despite this growth, India's share in the global medical device market is only 1.5%.

Moreover, India currently relies on imports for 80% of its medical devices. The government is developing medical device clusters and parks to address this dependency. These initiatives aim to bolster domestic manufacturing and reduce reliance on foreign products.

Framing New Standards

Reportedly, the new framework will include an essential principal checklist for safety and performance, giving manufacturers the flexibility to choose applicable standards for their devices. Compliance with these standards will be mandatory for all manufacturers.

"We are in the process of framing the standards for all kinds of medical devices available in the country," an official stated. BIS is revising its limited standards to encompass all products.

With technology evolving rapidly, periodic revision of standards is crucial to ensuring products meet the highest quality and safety benchmarks.

Updated standards facilitate trade and commerce, improve processes, ensure consistent quality, simplify product comparisons, enhance health and safety, conserve resources, reduce environmental impact, and promote technological advancements.

Ongoing Review Process

"Review of medical devices standards published by BIS is an ongoing dynamic process to align with the latest ISO standards that have undergone or are undergoing revisions," explained Rajiv Nath, forum coordinator at the Association of Indian Manufacturers of Medical Devices (AiMeD).

He expressed gratitude for the government's progress in publishing new standards for medical devices over the past five years, aligning with international ISO standards. This alignment aids manufacturers and procurement professionals in ensuring high-quality performance specifications.

The initiative to revise standards is part of a broader effort to ensure that India's medical devices are on par with global benchmarks. By enhancing the regulatory framework, the government aims to foster innovation, improve patient safety, and boost the domestic medical device industry.

Queries sent to the health ministry and BIS spokespersons remained unanswered at the time of reporting, indicating ongoing discussions and developments in this critical area.


About Chime India

The College of Healthcare Information Management Executives (CHIME) is an executive organization dedicated to serving senior digital health leaders. CHIME includes more than 5,000 members in 56 countries and two US territories and partners with over 150 healthcare IT businesses and professional services firms. CHIME enables its members and business partners to collaborate, exchange ideas, develop professionally and advocate the effective use of information management to improve the health and care throughout the communities they serve. CHIME's members are chief information officers (CIOs), chief medical information officers (CMIOs), chief nursing information officers (CNIOs), chief innovation officers (CIOs), chief digital officers (CDOs), and other senior healthcare leaders. The CHIME India Chapter became the first international chapter outside North America in 2016 and is now a community of over 70+ members in India. For more information, please visit www.chimecentral.org

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