High-Risk Medical Device Manufacturers Granted License Compliance Extension

The extension applies exclusively to manufacturers and importers who had already submitted their license applications to the central licensing authority before September 30, 2023.

In a recent development, the Drugs Controller General of India (DCGI) has announced an extension for manufacturers and importers of high-risk medical devices awaiting licenses.

The extension applies exclusively to manufacturers and importers who had already submitted their license applications to the central licensing authority before September 30, 2023. The CDSCO (Central Drugs Standard Control Organisation) issued a circular confirming this arrangement.

This decision is part of new regulations specifying that medical devices falling under the 'class C' and 'class D' categories cannot be sold without proper licensing.

In granting an extension, the government responded to the fact that many manufacturers had applied for licenses but were experiencing delays in receiving them.

These 'class C' and 'class D' medical devices includes critical equipment, including ventilators, imaging devices, oxygen therapy equipment, nebulizers, x-ray machines, surgical robots, and oncology treatment linear accelerators. The introduction of these new regulations is aimed at enhancing quality control measures in the industry.

Several manufacturers have reported applying for licenses as early as July but were still awaiting audits necessary for license approval. In a prior decision, the government had mandated that all medical devices, whether imported or locally manufactured, must be certified by the CDSCO before entering the market.

It's estimated that around 1,000 licenses are currently under processing for high-end, high-risk medical devices from 200-300 manufacturers. The Association of Indian Medical Devices Industry (AiMeD) had previously contacted Health Minister Mansukh Mandaviya, requesting an extension of the deadline for manufacturers by at least six months.

Medical devices are categorized based on their risk level, with 'class A' for low-risk devices, 'class B' for devices with low to moderate risk, 'class C' for devices with moderate risk, and 'class D' for devices with high risk.

This decision to extend the compliance period reflects the government's commitment to addressing the challenges high-risk medical device manufacturers face. It aims to ensure the uninterrupted availability of these critical healthcare products in the market, benefiting the industry and public health.

Notably, through its think tank, NITI Aayog, the government has highlighted the importance of adhering to specific safety and quality standards for all medical devices, a significant step toward enhancing healthcare quality in India.