Introduction:
The Government of India’s Directorate General of Health Services has introduced the National Single Window System (NSWS) Portal, aiming to simplify and streamline the approval process within the medical devices sector.
Objective of NSWS Portal:
The NSWS Portal is designed as a comprehensive platform to facilitate a simplified process for obtaining approvals, licenses, registrations, and clearances necessary for conducting business in the medical devices industry.
Development and Independence of NSWS Portal:
Developed in collaboration with TCS, Invest India has led the development of the NSWS portal, ensuring it caters specifically to activities under the Medical Devices Rules, 2017. Notably, this platform operates independently from existing portals like SUGAM and cdscomdonline.
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Activities on NSWS Portal:
From January 1, 2024, the NSWS portal will host three crucial activities:
- Application for grant of Certificate of Registration of a Notified Body (Form MD-01).
- Application for a license to manufacture medical devices for various purposes, including clinical investigations, tests, evaluation, demonstration, or training (Form MD-12).
- Application for License to Import Medical Devices for specific purposes (Form MD-16).
Transition Period and Portal Access:
Stakeholders engaged in these activities are urged to utilize the NSWS portal for submissions. The existing cdscomdonline portal for these activities will be deactivated from January 15, 2024. Access to the NSWS portal is available at https://www.nsws.gov.in, offering an intuitive user interface. A comprehensive user guide has been provided to facilitate easy navigation and utilization.
Ready to Streamline Your Medical Device Approvals With NSWS Portal?
NSWS Portal Guidance by Operon Strategist
Experience streamlined medical device approvals! The launch of the National Single Window System (NSWS) Portal by the Government of India marks a pivotal moment, promising transparency and efficiency in the medical devices sector.
Operon Strategist stands ready to guide you through this transformative platform. For personalized assistance in optimizing your medical device approvals and navigating the NSWS portal effectively, contact us today Elevate your operations in the medical devices industry with Operon Strategist’s expertise!
