The Central Government has launched a groundbreaking initiative, introducing the National Single Window System (NSWS) aimed at revolutionizing the process of importing medical devices. Designed as a one-stop-shop for investor approvals, this system is set to redefine the ease of doing business in the medical device sector.

Developed by Invest India in collaboration with TCS, the NSWS portal is set to go live on January 1st, 2024, marking a pivotal moment in regulatory efficiency. Notably, the portal will operate independently from the existing SUGAM and cdscomdonline portals.

Initially, the NSWS portal will focus on three crucial activities outlined in the Medical Devices Rules of 2017:

Grant of Certificate of Registration of a Notified Body (Form MD-01)

Licence for Manufacturing Medical Devices for Various Purposes (Form MD-12)

Licence for Importing Medical Devices for Specific Purposes (Form MD-16)

Starting January 1st, all stakeholders involved in these activities are mandated to submit their applications exclusively through the NSWS portal. To streamline the transition, the existing cdscomdonline portal for these activities will be phased out and disabled from January 15th, 2024.

This initiative signifies a significant leap toward modernizing and simplifying the bureaucratic hurdles faced by stakeholders in the medical device sector. By consolidating various approvals, licenses, registrations, and clearances into a unified platform, the NSWS portal aims to enhance transparency, efficiency, and the overall ease of conducting business in this critical industry.

The implementation of the NSWS portal reflects the government's commitment to fostering a more conducive environment for investment and innovation in the healthcare and medical device domain. Stakeholders are encouraged to adapt to this transformative change, poised to reshape the landscape of medical device import processes across the country.