National Single Window System for Medical Devices

As of January 1, 2024, the NSWS portal has gone live with three crucial activities under the Medical Devices Rules, 2017:

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Medical Device
Medical Device

Medical Devices

Download DCGI circular dated 01-01-2024 on launching of NSWS Portal, the link is given below: In an era where efficiency and simplicity are crucial for business growth, the National Single Window System (NSWS) emerges as a game-changer for medical devices.

Established by the Central Government, NSWS aims to create a centralized platform, functioning as a one-stop shop for all approvals necessary for investors, thereby fostering ease of doing business.

Invest India, in collaboration with TCS, has created the NSWS portal for CDSCO. This portal operates independently from the existing SUGAM portal or cdscomdonline portal.

NSWS: Simplifying Business Approvals

The primary objective behind NSWS is to simplify the cumbersome process of obtaining various approvals, licenses, registrations, and clearances.

By consolidating these requirements into a single window, the system seeks to reduce bureaucratic hurdles and streamline the path for investors, both domestic and international.

Collaborative Development by Invest India and TCS

The NSWS portal is a result of collaborative efforts between Invest India and Tata Consultancy Services (TCS).

This strategic partnership ensures the independence of NSWS from existing portals, a move aimed at enhancing functionality and user experience.

Key Activities Under the Medical Devices Rules, 2017

As of January 1, 2024, the NSWS portal has gone live with three crucial activities under the Medical Devices Rules, 2017:

  1. Application for grant of Certificate of Registration of a Notified Body-Form MD-01
  2. Application for licence to manufacture medical device for the 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

Stakeholders involved in these activities are urged to submit their applications exclusively through the NSWS portal. Notably, the existing cdscomdonline portal for these activities will be disabled from January 15, 2024.

NSWS: A Paradigm Shift in Approval Processes

The NSWS portal brings about a paradigm shift in the traditional approval processes.

It mandates that all concerned stakeholders, including Notified Bodies and entities involved in medical device manufacturing and import, transition to the NSWS portal for a streamlined and efficient experience.

Navigating the NSWS Portal

For stakeholders eager to explore the NSWS portal, the official website link is https://www.nsws.gov.in.

The user-friendly interface is designed to make navigation intuitive, ensuring a hassle-free experience for applicants.

Benefits for Stakeholders

The transition to NSWS promises significant benefits for stakeholders:

  • Streamlining Application Processes: The unified platform reduces the complexity of submitting multiple applications, ensuring a seamless process.
  • Enhancing Efficiency and Transparency: NSWS brings in efficiency by providing real-time updates and transparent communication throughout the approval process.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.


FAQs

  1. Q: When does the NSWS portal go live?
    • A: The NSWS portal has been live since January 1, 2024.
  2. Q: What are the key activities initially launched on NSWS?
    • A: The three activities under the Medical Devices Rules, 2017 are: MD-01, MD-12, and MD-16.
  3. Q: Is it mandatory to use the NSWS portal for the specified activities?
    • A: Yes, stakeholders must submit applications exclusively through the NSWS portal, as existing portals will be disabled.
  4. Q: How can stakeholders navigate the NSWS portal?
  5. Q: What benefits does NSWS offer to stakeholders?
    • A: NSWS streamlines application processes, enhances efficiency, and ensures transparency throughout the approval process.

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