BIS Standards for Medical Device Testing in India

As of September 2023, the CDSCO has approved a total of 39 laboratories across India to perform medical device testing and evaluation on behalf of manufacturers.

The Health Master

June 1, 2024

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Last Updated on June 15, 2024 by The Health Master

Medical Device Testing

The Drugs Controller General of India (DCGI) has taken a significant step towards ensuring patient safety by emphasizing the medical device testing and in-vitro diagnostics (IVDs) against Bureau of Indian Standards (BIS) standards.

This move aims to guarantee the quality and performance of these crucial medical products in India.

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BIS Standards

The DCGI has issued a circular to all stakeholders in the medical device sector, including testing laboratories and manufacturer associations, highlighting the requirement for BIS-compliant testing.

This regulation ensures that medical devices undergo rigorous evaluations based on established BIS standards, guaranteeing their quality and performance.

International Standards: A Safety Net

In cases where a specific BIS standard is unavailable, the DCGI clarifies that other recognized standards, as outlined in Rule 7 of the Medical Devices Rules (MDR), 2017, can be applied.

These include standards established by the International Organisation for Standardisation (ISO) or the International ElectroTechnical Commission (IEC), along with pharmacopoeial standards.

Finally, for devices lacking any specified standard, validated manufacturer’s standards can be employed.

Strengthening the Medical Device Testing Infrastructure

The Union Ministry of Health and Family Welfare, recognizing the importance of robust medical device testing facilities, has granted registrations to laboratories under Chapter X of the MDR, 2017.

This initiative empowers these labs to conduct tests and evaluations of medical devices on behalf of manufacturers.

A Call for Private Medical Device Testing Lab Participation

The DCGI has observed a concerning trend: medical devices with existing BIS standards are not always tested against them.

To address this gap, the central drug regulator has repeatedly urged private medical device testing facilities to register as Medical Devices Testing Laboratories (MDTLs).

This registration process strengthens the MDTL network, crucial for meeting the growing demand for high-quality medical device testing.

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Medical Device Safety

Since February 2020, with the implementation of relevant notifications, all medical devices fall under the purview of the Drugs and Cosmetics Act, 1940, and the MDR, 2017.

Expanding Testing Capacity: Meeting Industry Needs

The inclusion of more devices under drug regulations has necessitated a corresponding increase in testing facilities.

The CDSCO is actively working to establish the necessary infrastructure to ensure timely testing of both domestically manufactured and imported medical devices, preventing delays in market access for the industry.

Progress in MDTL Network Development

As of September 2023, the CDSCO has approved a total of 39 laboratories across India to perform medical device testing and evaluation on behalf of manufacturers.

This figure includes nine MDTLs registered in 2023, showcasing a growing network.

A Call to Action for Qualified Laboratories

In December 2022, the DCGI issued a call to action for qualified laboratories with the capacity for medical device testing to submit applications for registration.

This initiative aims to further strengthen the MDTL network in India.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.

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