NSW portal for Medical Devices

Central Government has launched a ‘one-stop-shop’ portal NSWS, designed by Invest India through Tata Consultancy Services (TCS) to streamline the import of medical devices in the country. This will be independent of the existing portals – the SUGAM portal or cdscomdonline portal. The existing portals will be disabled by January 15, 2024

The portal facilitates applications for the certificate of registration and licences to manufacture or import medical devices for various purposes such as clinical investigations, tests, evaluations, demonstrations, or training.

From January 1, 2024, the following three activities under the Medical Devices Rules, 2017 will be made live on the NSWS Portal:

i. application for grant of certificate of registration of a notified body- Form MD -01
ii.application for licence to manufacture medical device for clinical investigations, test, evaluation,  examination, demonstration or training- Form MD -12
iii.application for licence to import medical device for clinical investigations, test, evaluation, examination, demonstration or training- Form MD -16

All the stakeholders should submit the application for the above 3 activities, through NSWS portal only

Click the link below to read the detailed guide book on How to apply for CDSCO approval

Source:https://cdsco.gov.in/opencms/opencms/en/Home/

National Single Window System

National Single Window System (NSWS) is a one-stop-shop portal, and a medium of convenient and efficient online Government-to-Business (G2B) services to the business community, which reduces the complexity in obtaining information and services related to starting businesses in India and deals with various approvals, registrations and permits.

NSWS is a portal wherein investors/ entrepreneurs can identify, apply and obtain regulatory approvals and compliances as under applicable laws in India, for setting up and starting a business unit anywhere in India. However, the final authority of giving approvals lies with the Ministry/ Department/ State authorities and the internal process followed by the respective Ministries/ Departments/ States remains the same.

The Know Your Approvals (KYA) module supports information across 32 Central Departments and 17 States. However, there may be other approvals required that the investors may like to check at their own discretion. Currently, the portal hosts applications for approvals from 21 Central Departments and 14 State Governments

Objectives of NSW:

  1. To establish a single-window mechanism by integrating the services provided by various Central Ministries, Departments, and State Governments
  2. To provide a one-stop-shop for procuring pre-establishment and pre-operation approvals and permits required to establish a business in India
  3. To provide efficient, convenient, transparent, and integrated electronic service to investors, industries, and businesses
  4. To provide a uniform and seamless experience to the business user

Benefits of NSW Portal:

  • All approvals in one place
  • Transparency
  • Cost saving
  • Secure Document repository
  • Fast query management
  • Real time status tracking
  • Easy renewal
  • Integration with Other systems

NSW contribute to economic growth by reducing trade barriers and improving the overall efficiency of trade processes

Services that can be availed through the NSWS

  1. Identification of requisite pre-establishment and pre-operation approval for setting up of a business unit in India 
  2. Application of suggested approvals
  3. Digital repository for storing documents related to approvals
  4. Payment of processing fees to issue any approvals
  5. Post application, tracking and status update on applications submitted
  6. Easy Renewal
  7. Information about approvals such as timelines, fees, documents required etc.

Who can use this Portal?

The users of a National Single Window (NSW) portal typically include a wide range of stakeholders involved in international trade and logistics. The National Single Window System is designed and built for both foreign and domestic investors/ entrepreneurs of any sector, scale and size.

  1. Traders – Importers, exporters, and other businesses engaged in international trade
  2. Government Agencies
  3. Customs Brokers and Agents
  4. Transport and Logistics Providers
  5. Financial Institutions
  6. Certifying Bodies
  7. Trade Associations and Chambers of Commerce
  8. Information providers

How to use the NSWS portal?

An investor/ Business user is required to register on the National Single Window System (NSWS) by clicking on “Sign Up Now” before applying for any service from the portal.  The user requires an email ID and mobile number to register. Once they complete the registration process, they can apply for pre-establishment and pre-operation approvals given by the Ministries/ Departments/ States that are part of the NSWS.

The NSWS does not charge any fee for user registration. However, any fee/ charges required by the Ministry/ Department/ State to process the applications for approvals can be paid through the NSWS portal

For detailed guide on user registration and application submission, please visit https://www.nsws.gov.in/portal/user-guide

On the whole, The National Single Window portal benefits a broad spectrum of stakeholders by promoting efficiency, transparency, compliance, and collaboration in trade processes.

By addressing the diverse needs and interests of traders, government agencies, service providers, consumers, and society at large, an effective NSW system contributes to fostering a more resilient, inclusive, and sustainable trade ecosystem.

Source:https://www.nsws.gov.in/

https://www.investindia.gov.in/