India Launches National Single Window System for Streamlined Medical Device Approvals

• 04 Jan 2024

The Indian government has introduced the National Single Window System (NSWS) to simplify the import, clinical investigations, and testing processes for medical devices. This system, established as a genuine single-window platform, consolidates approvals required by investors, enhancing the ease of doing business in the sector.

Key Points

• Streamlining Medical Device Approvals: The NSWS aims to centralize and streamline the approval processes for medical devices, providing investors with a comprehensive platform for obtaining necessary certifications and licenses.
• Development by TCS: The NSWS portal has been developed by Tata Consultancy Services, a significant player in the information technology and consulting industry.
• The new portal supersedes previous platforms and is set to enhance the efficiency of application processes.
• Deadline for Existing Portals: The notice indicates that existing portals like SUGAM and cdscomdonline will be disabled by January 15, paving the way for the full implementation of the NSWS.
• Evolution from Investment Clearance Cell (ICC): The ICC's transformation into NSWS aligns with the government's commitment to offering a unified approach for investors, eliminating the need to navigate multiple platforms.
• Growing Demand for Medical Devices in India: India's demand for medical devices is projected to reach $50 billion by 2030. Presently, the country produces approximately $7.6 billion worth of medical devices, exporting around $3.4 billion.
• Draft Bill Controversy: The draft New Drugs, Medical Devices, and Cosmetics Bill, 2023, has faced opposition from various stakeholders, including medical device makers, patient interest groups, and hospitals.