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/

Tamil Nadu Global Investors Meet 2024

Tamil Nadu, with its robust educational system and a strong focus on Science, Technology, Engineering, and Mathematics (STEM), is rapidly emerging as a leader in the Global Capability Centres (GCC) landscape. The state’s journey from skill arbitrage to leadership arbitrage in this domain is a testament to its growing prowess and the trust it has garnered globally.

GCCs, which have been a part of India’s business ecosystem for decades, are witnessing a significant surge in Tamil Nadu. Renowned companies like Cognizant Technology Solutions (CTS), Genpact, and Flipkart are notable examples of businesses that have thrived in this space. Moreover, the state is becoming a hub for startups in the GCC sector, further diversifying and strengthening its position.

As of 2015, India was expected to host over 2025 GCCs, highlighting the sector’s rapid growth. Tamil Nadu, in particular, has been pivotal in this expansion, offering a market potential that ranges from $35 billion to $60 billion. The state’s ability to create a large number of GCC leaders, estimated between 5,000 to 25,000, is also noteworthy. This growth is attributed to the shifting of markets from the West to India, leveraging the country’s strong STEM education.

One of the key strengths of Tamil Nadu in the GCC arena is the close gap between engineering and end-users. Product managers in the state work closely with customers, unlike in the past, where GCCs focused only on building certain parts. This proximity enables the development of trusted relationships and a deeper understanding of end-user needs.

Talent acquisition and retention are other areas where Tamil Nadu excels. The state’s educational institutions, startups, and industries collaborate closely, creating a robust ecosystem that supports the growth and development of GCCs. This synergy is critical in understanding and adapting to consumption patterns in the fast-growing digital economy.

Despite these strengths, GCCs in Tamil Nadu have faced challenges. Initially, driving business transformation and achieving cost efficiencies were significant hurdles. However, these have been largely overcome, and today the focus is on co-innovation, joint IPs, and skill development in collaboration with the government and academia. Cultural gaps and trust-building, once significant challenges, are now areas where best practices have been established.

Opportunities abound in Tamil Nadu, especially in engineering R&D. Cities like Chennai and Coimbatore are recognized for their skilled talent, particularly in Tier 2 cities like Coimbatore. The state offers a comprehensive product portfolio, facilitated by the proximity of engineers, product managers, architects, and customers.

Tamil Nadu is also home to various GCCs from major players in diverse sectors, each contributing uniquely to the ecosystem. For example, Optimum Health focuses on simplifying and scaling healthcare innovation, while Reynold Nissan GCC leverages core automotive technology for local and global markets. Standard Chartered Bank and UPS have also established significant GCC presences in Chennai, tapping into the diverse talent pool and collaborative ecosystem.

In summary, Tamil Nadu’s strengths in education, innovation, and a collaborative ecosystem make it an ideal location for GCCs. The state’s ability to adapt to changing global needs, coupled with its focus on co-innovation and talent development, positions it as a leader in the GCC landscape. With continued investment and growth, Tamil Nadu is set to play an increasingly vital role in the global GCC sector.

Click the link below to watch the TNGIM2024 Day 1 & Day 2 sessions: https://www.tngim2024.com/live-event-listing

Source: https://tngim2024.com/

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/

Announcement from NABH

NABH announced that QCI and all its boards are introducing an innovative solution for addressing the queries & concerns promptly and transparently through “Quality Setu”, an integrated QCI portal designed to streamline the NABH helpdesk/complaints redressal process.

Quality Setu is a unified platform for all boards & divisions of QCI that will bridge and synergize the flow of information for its users.

It will also assist users to search for information regarding various schemes, certifications, accreditations, assessments, trainings and other projects, administered or run by the Boards & Divisions of QCI.

Quality Setu will also act as a single-window for all queries & concerns where users can track online, the progress of their engagement with the respective Board and Division, in their personalized section through the app or its portal

The system also has an AI-based Chatbot that guides users in their search and also assist them in resolving their queries and concerns in quick time.

From January 1, 2024, onwards, all queries and concerns pertaining to NABH will be exclusively addressed through the “Quality Setu” portal. This transition is aimed at enhancing efficiency, speedy resolution and ensuring a seamless experience for our stakeholders.

Please access the “Quality Setu” portal using the following website link
Website link: https://qualitysetu.qcin.org

Source: https://nabh.co/

Holistic AI E-book

The year 2022 was pivotal for artificial intelligence (AI), culminating in the emergence of ChatGPT and Microsoft’s subsequent discussions to invest $10 billion in OpenAI. With the AI market projected to grow to $500 billion in 2024, regulatory efforts have intensified in tandem with AI’s rapid adoption.

“The State of Global AI Regulations in 2024,”, a comprehensive guide released by Holistic AI ,sheds light on the following:
a. current state of the global AI landscape,
b. Key developments and anticipating trends in businesses
c. AI governance and its implications

Source:https://www.holisticai.com/papers/the-state-of-ai-regulations-in-2024

MedTech Mitra

Union Minister, Health & Family Welfare, Dr. @mansukhmandviya inaugurates “MedTech Mitra,” a groundbreaking initiative by ICMR and CDSCO, supported by NITI Aayog.

This turning point marks a landmark for India’s healthcare landscape, enabling affordable healthcare solutions for all citizens.

ICMR & CDSCO in collaboration with NITI Aayog have launched #MedTechMitra, a game-changer for India’s healthcare. Fostering innovation & strategic support for medical device and diagnostic development. It will strengthen ecosystem, with affordable solutions for all.

MedTech Mitra streamlines MedTech R&D with preclinical & clinical support, collaboration initiatives, & funding opportunities. It is a primary step towards building a robust, self-reliant ecosystem for affordable & accessible healthcare in India.

Source:https://medtechmitra.icmr.org.in/

Announcement – e-commerce exports handbook

The Union Minister of Commerce & Industry Piyush Goyal released a comprehensive “E-Commerce Exports Handbook for MSMEs” prepared by the Directorate General of Foreign Trade (DGFT) in New Delhi on Thursday.

The handbook, a significant initiative supporting the objectives of Foreign Trade Policy 2023, will serve as a definitive guide for MSMEs seeking to harness e-commerce platforms for expanding their exports.

It provides detailed insights into strategies for promoting exports via e-commerce,  facilitating MSMEs to venture into global markets effectively. This is part of the DGFT’s collaboration with different e-Commerce platforms/ enablers to hold training sessions in districts across the country with focus on promoting e-Commerce exports. The e-Commerce exports handbook for MSME will be a key resource for creating awareness e-Commerce exports through these outreach events in the districts.

The handbook, initially released in four languages namely English, Hindi, Gujarati and Kannada, will be translated into all official languages across India, ensuring accessibility and benefitting consumers, entrepreneurs, farmers, and women entrepreneurs looking to contribute significantly to trade and commerce

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

Announcement

Advertising industry’s self-regulatory body ASCI has proposed various guidelines to avoid ‘greenwashing’ by companies.

The Advertising Standards Council of India (ASCI) has come out with a 9-point draft in this regard.

ASCI said the guidelines are aimed to check greenwashing, which it defined as the deceptive practice of making misleading environmental claims.

Proposed guidelines aim to foster a culture of transparency and authenticity in advertising in consumer interest and help them make informed decisions.

Environmental claims can appear in advertisements, marketing material, branding (including business and trading names), on packaging or in other information provided to consumers

The proposed guidelines say any absolute claims like a product has no impact or only a positive impact needs to be supported by a high-level of substantiation.

Comparative claims such as “greener” or “friendlier” can be justified, for example, if the advertised product or service provides a total environmental benefit over that of the advertiser’s previous product or service or competitor products, it has been recommended.

The public consultation on the draft is open till December 31, 2023

Source: https://www.ascionline.in/

Training program

“Statistics for Non-Statisticians” program is organised by ekaagra solutions on Friday 5 Jan 2024 from 1530-1800 IST via Google Meet!

About the program :

This program is designed for those who think statistics is boring or too difficult.

Statistics is an indispensable part of numeracy, and is too important to be left to the so-called specialists. This program is designed to give you a feel for how to deal with numbers.

The program covers Central Tendency and Dispersion; Data Visualization; Distributions, Normality and Skewness; Confidence Intervals; Statistical Inference and the concept of Hypothesis Testing.

Who should attend :

Any member, who is interested to deal with numbers. Members from Sales and marketing , manufacturing, service, software, supply chain management, finance and accounting, HR or entrepreneurs ,who wants to deal with numbers. It is open for students also starting from class 11 to PhD.

Fee Details:

Enroll now for Rs 1000 with a variety of payment options available here: https://lnkd.in/gDmHxsW

Group discount schemes are also available for organisations. Students from class 11 all the way up to those pursuing their Ph.D. get a FLAT 50% off.

Last but not the least, there is a 25% early bird discount for those who register on or before Sun 10 Dec 2023. This can’t be clubbed with the student discount though.

Contact Details:

Please Contact Mr.Ramdas Menon for more details.
Email: ramdas@ekaagra.com

Minimum Viable Product (MVP) Guidance Document

NHA has published a Minimum Viable Product (MVP) Guidance Document for ABDM Compliant HMIS/LMIS Version 4.0

The document outlines the features which are recommended to be included in digital health solutions for a Clinic MIS, Hospital MIS, Lab MIS and Pharmacy MIS