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Manufacturers And importers Of High-Risk Medical Devices Granted Six-Month Extension

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Despite numerous medical device manufacturers submitting license applications, the government should have delivered them promptly.

In recent developments, the Indian government has granted a six-month extension to existing manufacturers and importers of high-risk medical devices that have applied for licenses. This decision comes in response to the Central Drugs Standard Control Organisation’s (CDSCO) earlier directive, which set October 1 as the deadline for bringing ‘class C’ and ‘class D’ medical devices under regulatory control as part of quality control efforts.

The CDSCO’s initiative aimed to tighten regulations around medical devices, covering a wide range of critical equipment such as ventilators, imaging equipment, oxygen therapy devices, nebulisers, x-ray machines, surgical robots, and oncology treatment linear accelerators. As per the new regulation, manufacturers and importers were required to obtain manufacturing licenses to continue selling these devices beyond October 1. However, many manufacturers had submitted their license applications well in advance, with many applying as early as July. Despite their proactive approach, they faced delays in the processing of their applications, primarily due to challenges associated with application review and processing. This situation created uncertainty for these businesses, as they risked losing their ability to manufacture or import essential medical devices.

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In response to this issue, the government issued a circular dated October 12, providing much-needed relief to these manufacturers and importers. According to the circular, any existing importer or manufacturer who had already applied for licenses for class C or class D medical devices would be granted a six-month extension. This extension would allow them to continue importing or manufacturing these devices until a decision on their license application is made or six months from the issuance of the circular, whichever comes earlier.

Rajiv Nath, the forum coordinator of the Association of Indian Medical Devices Industry (AiMeD), expressed relief at the government’s decision, acknowledging the challenges faced by manufacturers who had timely applied for licenses but were awaiting audits as part of the application process. This reprieve offers a much-needed buffer to ensure a smooth transition to the new regulatory framework while maintaining the availability of critical medical devices in the market. Overall, this extension provides a pragmatic solution that balances the need for enhanced regulatory oversight with the realities of the industry’s application processing timelines, offering assurance to manufacturers and importers in the high-stakes field of medical devices.

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