The National Single Window System Portal (NSWS) was launched on 1 January 2024 as a one-stop centre to facilitate investors and stakeholders in the applications of registration certificates and licenses to manufacture or import medical devices for various purposes, for instance, clinical investigations, tests evaluations, demonstrations, or training.
Streamlining business processes was simplified for the stakeholders and investors, at the same time eliminating the need to navigate through multiple systems to apply, track, and obtain necessary information for business approvals. NSWS Portal will be working independently from the CDSCO online portal and SUGAM portal including the activities listed below under the Medical Devices Rules, effective from 1 January 2024:
Application for grant of Certificate of Registration of a Notified Body
Application for license to manufacture medical device for clinical investigations, tests, evaluation, examination, demonstration, or training (Form MD-12)
Application for License to Import Medical Devices for Clinical Investigations, Tests, Evaluations, Demonstrations, or Training (Form MD-16)
Hence, all stakeholders are required to submit applications related to the activities listed above through the NSWS portal and the existing system under CDSCO will be disabled effectively from 15 January 2024.
Contact us at info@arqon.com for more information.