India Launches National Single Window System for Streamlined Medical Device Approvals

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.