On January 1, 2024, the Government of India launched a national single window system for investors and companies to facilitate the import of medical devices, clinical trials, and testing. The portal will integrate the existing control systems of central and state agencies and become a single point for issuing required approvals and permits for investors, entrepreneurs, and companies in India. It terminates the need for multiple applications in different portals.

Tata Consultancy Services (TCS) has developed the NSW portal, which is different from the existing SUGAM and cdsco md online portals. It facilitates applications for registration certificates and licenses to manufacture or import medical devices for various purposes, including clinical trials, test evaluation, demonstrations, and training. Finance Minister Nirmala Sitharaman had earlier announced the establishment of an Investment Classroom (ICC) in her budget speech on February 1, 2020. The proposed ICC, now being developed like NSW, enables investors to identify, apply, track, and obtain necessary approvals before starting a business in India eliminating the need for investors to visit multiple IT platforms and agencies, Central Drug Standard Organization (CDSCO)

Introduction

Demand for medical devices in India is projected to reach $50 billion by 2030. As of now, India produces approximately $7.6 billion worth of medical devices and exports about $ 3.4 billion. India’s annual demand for medical equipment is about approximately $ 12 billion, with imports accounting for nearly $ 7.6 billion, or more than 60 percent of domestic demand. However, the New Drugs, Medical Device and Cosmetic Act 2023, which is expected to soon be tabled in Parliament, attracted opposition from manufacturers of medical devices, patient advocates, and hospitals. They favor a separate medical device law separate from drugs.
The NSWS system is currently in beta testing and is considered the first major step towards digitizing business.

The platform enables online archiving and tracking of all applications and reports. This would help investors get approvals from various stakeholders without physically visiting various government offices.
Under the Medical Devices Regulations 2017, three features have been developed and published on the NSWS portal:

• Form MD-01: Application for a Notified Body Registration Certificate.
• Form MD-12: Application for a license to produce Medical Devices for Clinical Research, Testing, Evaluation, Inspection and Training 
• Application for Import Permit of Medical Devices for Clinical Research or Testing, Evaluation, Demonstration- MD-16.  Above, all interested parties are requested to submit applications for the above-mentioned three functions only through the NSWS portal. 

--------------Blog Contact Form-------------

Services Offered

The National Single Window System offers all the following to facilitate the approval process for entrepreneurs and investors.

• Identify Approvals: The Know You Approvals (KYA) tool helps users identify required approvals based on their industry location and company type. This reduces research time and effort
• Apply for Approval: Once the fundamental endorsement has been distinguished, clients can submit their applications electronically through the NSWS platform. This would remove the need for physical applications and manual submissions. 
• Tracking and Status: Users can track the status of applications in real time and receive updates on progress or requirements. This transparency helps in efficient planning and management of the approval process.
• Document storage: Users can securely all documents related to their applications in the digital archive of the NSW portal. This eliminates the need for physical copies and simplifies data storage.
• Easy Renewal: Approvals requiring reestablishment can be easily renewed through the NSWS portal instead of modern applications 
• Payment of Fees: The processing fees can be paid electronically through the NSWS portal, making the process convenient and secure.
• Information and Support: The NSWS portal provides detailed data on approvals, processes, and fees. There is also a dedicated support service that answers client-related questions and provides support.

Objectives

• The National Single Window System aims to achieve the following objectives:
• Provide Transparency and predictability through clear information and approval timelines.
• Provide Uniform approvals for companies, and simplify the process for investors.
• To facilitate doing business in India, attract more investment, and accelerate growth.
• Possible to win reduces costs and delays associated with obtaining business permits. 
• Promotes effective communication between companies and authorities.
• Procures economic growth by attracting investment and creating jobs.
• Establishes trust among investors through a user-friendly platform.

Benefits

Here are some Key Benefits of the National Single Window System:-

• Time Efficiency: NSWS greatly reduces the time and effort required to understand and obtain the approvals required for the business. The digital format means you can access and search for information from the comfort of your office or home.
• Transparency: The system promotes transparency in the approval process and ensures companies have clear guidelines on what they must do to comply with government regulations.
• Cost Savings: Simplifying the approval process reduces the financial burden on businesses as they can avoid unnecessary delays and costs 
• Centralized access: With multiple approvals available through NSWS, you don't need to navigate multiple government websites or agencies to meet regulatory requirements.
• Easier to Do Business: A simplified and faster approval process will attract investment and make it easier for companies to operate in India.

Conclusion

The National Single Window System (NSWS) Launched by the Government of India, offers a transformative approach to business approvals, streamlining processes, increasing transparency, and accelerating economic growth. Provided with a user-friendly digital platform, NSWS simplifies the agreement process for investors and entrepreneurs and benefits the government by increasing efficiency, reducing administrative burden, and increasing revenue. With its standardized procedures and comprehensive services, NSWS is a significant step in creating a more favorable environment for doing business in India, ultimately contributing to the country’s development.

Ultimately, the National Single Window System is a pioneering initiative in line with India’s broader efforts to facilitate trade within the country. By providing a single digital gateway for approvals, it allows companies to focus on what they do best regulatory growth and prosperity.

The Know Your Approvals feature relies entirely on the information you provide and is only indicative of identifying the list of approvals and registrations your business may require. This list does not constitute legal opinion or advice and is not a substitute for independent professional advice.

This is an important step towards making India a friendlier environment and promoting entrepreneurship and economic growth.