The New National Single Window System (NSWS) Portal for Medical Device Regulatory Approvals, Registrations & Licenses
The National Single Window System (NSWS) is established by the Central Government of India to build a genuine single window system which acts as a one-stop shop for all the approvals required by the investor and facilitates ease of doing business.
The scope of NSWS includes all the approvals/licenses/registrations/clearances as applicable.
In this NSWS portal, initially following three activities under the Medical Devices Rules, 2017 have been developed and will be made ‘Live’ on NSWS portal from 1 January 2024.
Form MD-01
Application for grant of Certificate of Registration of a Notified Body
Form MD-12
Application for licence to manufacture medical device for purpose of clinical investigations, test, evaluation, examination, demonstration or training
Form MD-16
Application for Licence to Import Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training
From 1 January 2024, all concerned stakeholders should submit application related to Notified Body Approval, Medical Device Test License, and Medical Device Import License for Testing Purpose through NSWS portal only.
The existing SUGAM Portal will not be disabled for Notified Body Approval, Medical Device Test License, and Medical Device Import License for Testing Purpose from 15 January 2024.
The NSWS portal can be browsed through https://www.nsws.gov.in.