Express Healthcare

Government launches NSWS Portal for efficient medical devices import streamlining

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Invest India through TCS has developed NSWS portal has been developed for CDSCO, which will be independent from the existing SUGAM portal or cdscomdonline portal

National Single Window System (NSWS) is established by the Central Government with the objective to build a Single Window System which act 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 regard, Invest India through TCS has developed NSWS portal has been developed for CDSCO, which will be independent from the existing SUGAM portal or cdscomdonline portal. Initially following three activities under the Medical Devices Rules, 2017 have been developed and will be made ‘Live’ on NSWS portal w.e.f. 01.01.2024:

  1. Application for grant of Certificate of Registration of a Notified Body-Form MD-01.
  2. Application for licence to manufacture medical device for purpose of clinical investigations, test, evaluation, examination, demonstration or training-Form MD-12.
  3. Application for licence to Import Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training -Form MD-16.

All concerned stakeholders need to submit application related to above said three activities through NSWS portal only and the existing cdscomdonline portal for the said activities will be disabled w.e.f. 15.01.2024.

The NSWS portal can be browsed through https://www.nsws.gov. in

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