Industry

Regulatory Changes: Relief for Class C and D Medical Device in India

October 13, 2023

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Last Updated on December 31, 2023 by The Health Master

Regulatory Changes

Regulatory Changes: In a recent development, the Drug Controller General of India (DCGI) has extended a lifeline to manufacturers of Class C and D medical devices.

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These manufacturers, who had diligently submitted their licensing applications before the September 30, 2023 deadline, have been granted a six-month reprieve.

This significant decision, outlined in the DCGI’s missive dated October 12, 2023, aims to ensure business continuity for these crucial players in the medical device industry.

Download DCGI circular dated 12-10-2023

A Brief Regulatory Background

In February 2020, the Indian government set forth a 42-month ultimatum culminating on October 1, 2023, mandating all Class C and D medical device manufacturers to secure licenses.

However, a wave of representations from diverse industry associations and stakeholders prompted the Central Drugs Standard Control Organization (CDSCO) to reconsider the potential disruptions looming over the industry due to the abrupt imposition of the new licensing regulations.

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The DCGI’s Decree

The DCGI’s letter elucidates the contours of this timely extension.

It stipulates that if an existing importer or manufacturer, already engaged in the production or import of Class C or Class D Medical Devices, has duly filed an application with the Central Licensing Authority, their application shall be considered valid.

This validation permits the importer or manufacturer to continue their operations for an additional six months from the date of this order or until a decision is reached by the Central Licensing Authority, whichever transpires first.

Alleviating Industry Concerns

This extension serves as a welcome respite for medical device manufacturers who had been grappling with the uncertainty surrounding their pending license applications.

Astonishingly, nearly 200 manufacturers found themselves without licenses, despite timely submissions, creating a bottleneck in the production and distribution of these critical medical devices.

Industry Perspectives

The Association of Indian Medical Device Industry (AIMED), expressed gratitude for the government’s intervention.

He acknowledged the challenges in the application review and processing, which had left many manufacturers in a state of limbo.

Nath also urged the government to tap into the wealth of expertise available through Quality Management System Certification Bodies accredited by the Quality Council of India for the voluntary Quality Assurance Indian Certification of Medical Devices (ICMED) scheme, a practice already in place for lower-risk Class A and B medical devices.

This, he believes, will fortify the sector and ensure uninterrupted access to vital medical devices for consumers.

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