With the consistent rise in demand for medical devices and pharmaceuticals, a streamlined regulatory approval system was very necessary. Moreover, India is aiming to become the global hub for medical devices and pharmaceuticals. Thus, a platform for seamless and efficient regulatory approval was the need of the hour. A user-friendly platform simplifying the regulatory approval process to meet the growing demands for healthcare essentials will boost innovation. Hence, the Government of India introduced a revolutionary digital platform called the National Single Window System (NSWS). This single point of contact aims to simplify, improve, and expedite the regulatory approval and registration process in India. Notably, this cutting-edge digital platform aligns with CDSCO’s aim of modernizing regulatory frameworks in India.

What is the National Single Window System portal?

On 1^st January, 2024, the Central Drugs Standard Control Organization (CDSCO) notified all stakeholders regarding the National Single Window System. The National Single Window System or NSWS is a single digital portal for the regulatory application process from submission of application, processing, and tracking to approval. By combining multiple steps of the regulatory approval process into a single interface, this portal promotes transparency, accountability, and strict regulatory compliance. Thus, the NSWS promotes an environment conducive for medical device and pharmaceutical innovation. This single window clearance system for medical device licensing and registration is vital for manufacturers, importers, and Indian agents. Additionally, remote submission and real-time online review and tracking are key highlights of this portal.

As of 1^st January, 2024, the following activates under MDR, 2017 has been made live on the NSWS portal: 

• Form MD-01 for certificate of registration for the Notified Body.
• Form MD-12 for applying for license to manufacture medical devices intended for clinical testing, demonstration, training, and evaluation.
• Form MD-16 for applying for license to import medical devices intended for clinical investigations, training, testing, demonstration, and evaluation.

From January 15, 2024, all these above-mentioned activities have been disabled from the existing cdscomdonline portal.

All necessary formalities can be completed on this single portal. Thus, the NSWS portal has helped speed up the approval process. This streamlined single point of contact for simplifying the Indian regulatory approval process is aimed at facilitating the ease of doing business in India. The goal of CDSCO’s NSWS portal is to reduce the regulatory hassle faced by investors and entrepreneurs. Additionally, National Single Window System promotes patient safety and innovation as well as protects public health.

Notable features of the CDSCO’s NSWS portal

Previously, applicants had to interact with multiple departments, do a lot of paperwork, and submit documents to different concerned departments. Additionally, the application process used to be confusing with no single portal stating the required documentation. Moreover, owing to lack of coordination among departments, there used to be discrepancies and confusion. The CDSCO’s National Single Window System will do away with all these hassles in the regulatory licensing and registration process. This is a single interface to speed up and track the application process. Furthermore, it provides information on the necessary documentations and fees required for each application.

Major highlights of the portal:

1. User friendly dashboard: Applicants can manage approvals using the portal dashboard.
2. The “Know Your Approvals (KYA)” feature: To understand the approval requirements and the required licenses, applicants can use this feature. The KYA feature provides all the documentation information in a single place.
3. Submitting the application: On this interface itself, new users can login/create accounts and apply for registration and licensing. This will trigger a pre-registration form.
4. Checklist for easy application: The pre-registration form will activate a checklist. This checklist will guide the applicant with all the necessary information required for the application.
5. Legal form: The applicants can preview and download the legal form containing the responses for their application.
6. Online document submission: The users can submit the documents online and review the application digitally.
7. Easy tracking of application status: For further simplifying the application process, this portal provides an application tracking feature. Moreover, if required, additional necessary documents can be uploaded using this portal itself.

Primary NSWS portal objectives

• Single portal that acts as a direct contact between applicants and authorities.
• Easy and uniform license application, thereby streamlining the application process.
• Reduction in costs and delays caused by interference of multiple departments and interfaces.
• Timely approval making the whole application process easy for entrepreneurs and investors. Furthermore, this promotes a favourable environment for research and development.

Technology required for using the NSWS portal

• Digital Signature Certificate (DSC) acting as the connection between the NSWS and the DSC. Additionally, the DSC should be loaded with the latest emBridge software
• Operating systems, such as Windows XP or higher or MAC OS X 10.9 or higher, with the latest updates, which can support the portal.
• Web browsers (Google Chrome, Mozilla Firefox, or Apple Safari) compatible for the National Single Window System portal.

The National Single Window System Portal services

The NSWS provides the following essential services:

• Tracks the application once it is submitted by the applicant.
• The NSWS acts as a digital repository storing the documents that are pending for approval.
• The portal communicates to all stakeholders the rules, procedures, and guidelines for license application and approval.
• Once the applicant submits the application and supporting documents per guidelines, the portal is used to approve the application.
• The National Single Window System portal handles the application processing fees.
• The portal is used to display any updates on necessary documents required, fee structure, time period required for approval, etc.
• Existing licenses are also renewed using this portal.

What are the advantages of National Single Window System?

The launch of the CDSCO’s NSWS portal is aimed at revolutionizing the licensing and registration application process. The advantages of this digital portal are as follows:

1. A user-friendly digital platform simplifying and streamlining the regulatory approval process.
2. The CDSCO’s NSWS portal is a single digital portal for all licensing and registration-related processes. Additionally, the portal can be used to track the status of the application. This digital platform has made it easier for companies to complete the registration process and secure licenses.
3. By fast tracking the application and license approval process, this portal has made it easier to set up businesses in India. 
4. One portal for monitoring regulatory compliance and other activities to avoid any discrepancies.
5. By offering a favourable environment for registration and licensing, the portal will help establish more medical device and healthcare product manufacturing businesses in India. Furthermore, this will reduce India’s import dependence for these products.
6. With this single NSWS portal, there is no need for various portals for resolving queries and issues. It acts as a direct point of contact between the authorities and applicants.

The NSWS portal: A user-friendly digital platform

The CDSCO processes a high volume of drug and medical device license and registration application. Hence, for the ease of industry stakeholders planning to do business, a streamlined regulatory approval process was much needed. Thus, the launch of the NSWS portal has revolutionized India’s regulatory approval process. Moreover, this digital platform promotes efficiency, transparency, and accountability. The National Single Window System portal aligns with India’s vision and mission to offer high quality and safe healthcare essentials. CDSCO monitors and regulates medical devices, drugs, and cosmetics being marketed in India. Furthermore, CDSCO registration and license are mandatory to launch these products in India. Navigating the CDSCO registration and license application process is not an easy task. However, we at Pharmadocx Consultants will make it a cake walk for you. Simply call/Whatsapp on 9996859227 or drop an email at [email protected].