Last Updated on May 28, 2024 by The Health Master
Medical Devices
The Central Drugs Standard Control Organisation (CDSCO) has provided a sigh of relief to manufacturers and importers of Class C and D medical devices.
In a move to ensure business continuity, the CDSCO has granted a 3-month extension for companies whose license applications are still pending with the authority.
Addressing Industry Concerns
This decision comes after the industry expressed concerns about potential disruptions due to the mandatory licensing regime for Class C and D devices, which came into effect on October 1, 2023.
Many industry associations and stakeholders submitted representations to the CDSCO, highlighting the challenges they faced in meeting the licensing deadline.
Key Points of the Extension
Eligibility:
Existing importers and manufacturers of Class C and D medical devices who submitted their license applications on or before September 30, 2023, are eligible for the extension.
Duration:
These companies can continue importing or manufacturing their devices for an additional three months from the date of the CDSCO’s order or until a decision is made on their license application, whichever comes first.
Rationale:
The extension aims to minimize disruptions and allow for a smoother transition to the new licensing regime.
Background
The Ministry of Health and Family Welfare, through a notification dated February 11, 2020, brought all medical devices under the purview of the Drugs and Cosmetics Act, 1940.
To ensure their proper regulation, the Ministry implemented a phased licensing regime:
- October 1, 2022: Class A and B devices were brought under the licensing regime.
- October 1, 2023: Class C and D devices were mandated to obtain licenses.
Challenges Faced by the Industry
The implementation of the licensing regime has encountered some initial hurdles:
Limited Testing Labs:
The industry has faced a shortage of quality testing laboratories equipped to handle the influx of Class C and D device applications.
Skilled Manpower Gap:
Concerns have been raised regarding the availability of adequately trained personnel to manage the new regulatory framework.
High Fees:
A section of the industry has expressed concerns about the high fee structure associated with testing and license application processes.
These fees could potentially impact the viability of small and medium-sized manufacturers.
Looking Forward
The CDSCO’s extension provides temporary relief for the industry. However, long-term solutions are needed to address the challenges mentioned above.
Building infrastructure for testing facilities, developing training programs, and potentially revising the fee structure could be some key areas of focus for the CDSCO and the Ministry in the coming months.
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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