What is the NSWS?

The Government of India (GoI) introduced a digital platform called the National Single Window System (NSWS) to simplify the process of obtaining Regulatory approvals and registrations for medical devices in India by consolidating them into a single location. The primary objectives of the NSWS are:

  • It serves as a one-stop shop for investors seeking various approvals, licenses, registrations, and clearances required for conducting business operations in India.
  • It helps medical device manufacturers and importers register their products in India through a unified mechanism that integrates services provided by different central ministries, departments, and state governments.

The single-window portal is an initiative of the Department for Promotion of Industry and Internal Trade (DPITT), Invest India, and the Central Drugs Standard Control Organization (CDSCO), and it is aimed at facilitating the ease of doing business in India. Notably, it functions independently from the existing SUGAM and cdscomdonline portals and is tailored specifically for services related to the CDSCO.

Understanding the Impact of the NSWS on the Medical Device Registration Processes

The NSWS is vital for all medical device manufacturers, importers, and Indian agents, as this portal has begun transitioning key activities under the Medical Devices Rules (MDR), 2017, from January 1, 2024. Its primary objective is to streamline regulations, alleviate burdens on businesses, prioritize patient safety, and promote innovation. Moreover, ICEGATE, the portal used for customs clearance, is now integrated into the NSWS portal. It provides a single window clearance system for medical device licensing, allowing remote submission and real-time online review. The following functions have been developed and have been made live on the NSWS portal with effect from January 01, 2024, and the existing cdscomdonline portal for these activities has been disabled from January 15, 2024.

  • Form MD-01: Application for issuing a certificate of registration for the Notified Body (NB).
  • Form MD-12: Application for issuing a manufacturing license for medical devices designated for clinical investigations, testing, and evaluation purposes.
  • Form MD-16: Application for issuing import licenses for medical devices designated for clinical investigations, testing, and evaluation purposes.

However, the CDSCO has not yet specified the timelines for transitioning other medical device applications and licenses.

What is the Status of Current Approvals?

As of now, current approvals for medical devices remain unchanged. However, moving forward, all submissions by manufacturers, importers, Notified Bodies (NBs), and other stakeholders must go through the NSWS application process.

Technical Requirements of the NSWS

  • Supported operating systems (Windows XP or higher, MAC OS X 10.9 or higher, with the latest updates), and compatible web browsers (Google Chrome, Mozilla Firefox, Apple Safari).
  • A Digital Signature Certificate (DSC) with the latest emBridge software, which serves as a connector between the NSWS and the DSC.

Key Attributes and Inaugural Actions on the NSWS

  • Central “Know Your Approvals (KYA)”: Users can utilize a KYA feature to identify necessary approvals through a questionnaire, facilitating a better understanding of approval requirements.
  • Dashboard Management: Users can manage approvals via the dashboard, adding approvals from the “All Approvals” section or through the central KYA process.
  • Application Submission: New users can sign up, create accounts, and apply for approvals, starting with a pre-registration form that activates a tailored checklist.
  • Checklist Activation: Based on the pre-registration form, a checklist is activated to ensure that all the necessary information is provided for the approval process.
  • Legal Form Viewing: Users can preview and download the legal form containing their application responses.
  • Document Uploading and Submission: Users can upload documents, review their applications, and digitally submit them using a DSC.
  • Application Tracking: After submission, users can track their application status and submit additional documents, if required.

The escalating demand for medical devices in India necessitates a streamlined Regulatory approval process and compliance with import requirements and state specifications. The NSWS assists medical device manufacturers seeking to register their products in India, ensuring a clear understanding of regulations and simplifying operations to meet growing demands. Freyr collaborates with medical device manufacturers and importers, aiding them in medical device registration in India. With access to the NSWS portal, we guide you through the requirements, provide you with checklists, and assist you in your applications. Contact us to learn more about how Freyr can support your entry into the Indian medical device market.