Single-window portal for medical devices gets operational

NSWS has been established as a “genuine single-window system, which acts as a one-stop shop for all the approvals required by the investor and facilitates ease of doing business

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New Delhi: In a move to streamline the import, clinical investigations, and testing of medical devices, the union government has launched the National Single Window System (NSWS).
In a notice dated January 1, 2024, Rajeev Raghuvanshi, Drugs Controller General of India, mentioned that the NSWS has been established as a “genuine single-window system, which acts as a one-stop shop for all the approvals required by the investor and facilitates ease of doing business”.
The scope of NSWS includes all the approvals, licenses, registrations and clearances as applicable.
The NSWS portal, distinct from the existing SUGAM and cdscomdonline portals, has been developed by Tata Consultancy Services (TCS). It facilitates applications for the certificate of registration and licences to manufacture or import medical devices for various purposes, including clinical investigations, tests, evaluations, demonstrations, and training. The existing portals will be disabled by January 15, the notice stated.
The regulation of medical devices in India is primarily overseen by the Central Drugs Standard Control Organization (CDSCO), which operates under the Ministry of Health and Family Welfare.
The regulatory framework for medical devices falls under the purview of the Drugs and Cosmetics Act, 1940, and the Medical Devices Rules, 2017. The Medical Devices Rules, 2017, classify medical devices into four categories (A, B, C, and D) based on their associated risks. The classification determines the regulatory requirements for approval.
Medical device manufacturers and importers are required to register their products with the CDSCO. Some high-risk devices may require pre-market approval from the CDSCO before they can be marketed in India. Manufacturers are often required to adhere to a quality management system, such as ISO 13485, as part of the regulatory compliance.