CDSCO Seeks More Medical Device Testing Laboratory Registrations

CDSCO is responsible for upholding the safety, efficacy, and quality of medical devices under the Medical Device Rules, 2017 (MDR, 2017).

The Health Master

April 9, 2024

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Last Updated on April 19, 2024 by The Health Master

CDSCO

The Indian medical device industry is experiencing significant growth, and to keep pace, the Central Drugs Standard Control Organisation (CDSCO) is actively seeking applications from private medical device testing facilities to register as Medical Devices Testing Laboratories (MDTLs).

This move aims to bolster the MDTL network and ensure timely, high-quality testing for both domestically manufactured and imported medical devices.

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The Need for More Medical Device Testing Facilities

The CDSCO is responsible for upholding the safety, efficacy, and quality of medical devices under the Medical Device Rules, 2017 (MDR, 2017).

With the implementation of crucial notifications in February 2020, all medical devices now fall under the purview of the Drugs and Cosmetics Act, 1940, and the MDR, 2017.

This expanded regulation necessitates a robust infrastructure for testing these devices efficiently to avoid delays in market access for manufacturers.

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Strengthening the Private Medical Device Testing Network

Dr. Rajeev Singh Raghuvanshi, the DCGI, acknowledges that select private testing labs are already registered under the MDR, 2017, for specific medical device testing.

To further strengthen the network of private testing facilities, the CDSCO is actively identifying existing private labs with the necessary capabilities to perform medical device testing. These labs are encouraged to register under the MDR, 2017.

Types of Medical Device Testing Required

Medical devices undergo a battery of tests to ensure their safety and effectiveness.

These tests encompass various categories, including:

Physical Testing
Chemical Testing
Microbiology Testing
Mechanical Testing
Electrical Testing

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How to Apply for MDTL Registration

The DCGI encourages all stakeholders to identify their facilities’ capabilities for conducting the aforementioned medical device tests.

If your lab possesses this expertise, you can submit an application for registration as a testing laboratory on behalf of manufacturers.

The application process involves submitting Form MD-39 along with the required information and fees as outlined in the MDR, 2017.

Current Status of MDTL Network in India

As of September 2023, the CDSCO has authorized a total of 39 laboratories across the nation to perform medical device testing and evaluation on behalf of manufacturers who apply under Form MD-40 of the MDR, 2017.

This figure includes nine MDTLs that applied in 2023, such as the laboratories of HLL Lifecare Ltd (a public sector undertaking) and the Atal Incubation Centre (AIC) Medivalley at the Andhra Pradesh MedTech Zone (AMTZ).

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Previous Call to Action for MDTL Registration

In December 2022, the DCGI issued a similar call to action, urging laboratories with the capacity for medical device testing and accreditation by the National Accreditation Board for Testing and Calibration Laboratories (NABL) to submit applications for MDTL registration.

This initiative aimed to strengthen the MDTL network throughout India.

The Rise of a Regulated Medical Device Industry

Prior to 2017, the Indian medical device sector remained largely unregulated. However, the introduction of the MDR, 2017, by the Ministry of Health and Family Welfare (MoHFW) marked a turning point.

This regulation established a comprehensive framework for the phased regulation of medical devices, focusing on quality, safety, and efficacy, under the Drugs and Cosmetics Act, 1940.

The government further categorized medical devices into four classes and implemented a licensing regime in phases, ensuring all devices fall under this system by 2023.

By actively encouraging private labs to register as MDTLs, the DCGI is making a significant stride towards ensuring a robust and efficient medical device testing ecosystem in India.

This, in turn, will benefit both manufacturers by accelerating market access and, most importantly, patients by ensuring the availability of safe and high-quality medical devices.

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.