Category: Manufacturing Sector

One Day National Conference on Standards, Certifications & Regulations

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One Day National Conference on Standards, Certifications & Regulations – Andhra Chamber of Commerce

Andhra Chamber of Commerce, a 95 year old Chamber of commerce with headquarters in Chennai, is organising a One day National Conference on Standards , Certifications and Regulations covering following sectors :

– Agri and Food Products
– Gems and Jewellery
– Leather and Footwear

Program covers sessions on Global Market Opportunities for Businesses and various applicable Domestic and International Standards, Certifications and Regulations the businesses have to comply with, while exporting products.

Program Details are given below :

Date : February 23, 2024 – Friday
Time : 10 am to 5 30 pm
Location : Hotel Ramada Plaza, Guindy, Chennai

Who Should Attend ?

Food & Agri Product Companies, Producer Groups : This is an opportunity for Farmers, FPOs, Producer groups, such as cooperatives, consortiums, and producer organizations, Manufacturers, Exports, Traders, Distributors, Retailers, Resellers, Startups, Innovators, Ecommerce companies, Testing labs, other key stakeholders etc from Food and Agri Products space to understand more about Export Opportunities and related Regulations, Standards , Certifications, Product Testing norms that businesses have to meet to Go Global.

Registration :

There is NO FEE. Program is open for industry members, other stakeholders from respective sectors, but prior registration is a must.

𝐃𝐞𝐥𝐞𝐠𝐚𝐭𝐞 𝐑𝐞𝐠𝐢𝐬𝐭𝐫𝐚𝐭𝐢𝐨𝐧 𝐋𝐢𝐧𝐤 :
https://bit.ly/3T7QdcQ

Do visit Chamber Page for more info, updates
http://www.andhrachamber.com/

It’s an initiative from Chamber to sensitise industry on an ongoing basis about International Trade Opportunities and market access norms that businesses have to comply with

For more details, please contact :

Mr Barnabas Immanuel
Program Co-ordinator
Phone : 24315277/78
Mob:7305063885
Email : andhrachamber1@gmail.com
acc@andhrachamber.com

Click here for Program Brochure
Click here to register

Regulatory Guidelines for Sampling of Drugs

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REGULATORY GUIDELINES FOR SAMPLING OF DRUGS, COSMETICS & MEDICAL DEVICES BY DRUGS INSPECTORS OF CENTRAL & STATE DRUG AUTHORITIES

Drugs Inspectors of Central & State Drug Authorities have released the guidance document for sampling of drugs, cosmetics & medical devices vide their circular dated 9th feb 2024.

This guideline is mainly focused to utilize available information & identified risks for selection of sample & location to cover vast variety of drugs, cosmetic and medical devices moving in the market from manufacturing facility, wholesale outlet, retail outlet, government distribution channel etc.

This guideline will be useful for effective surveillance for quality & efficacy of drugs & cosmetic available in the market by adopting uniform drug sampling methodology for drugs inspectors under drug regulatory authorities of state and central.

The main objective of the sampling is to check the quality & efficacy of drugs & cosmetic available in the market with their approved specifications. This involves:

 Monitoring the quality of the API, Excipients and finished products of drugs, cosmetic and medical devices in all parts of the distribution chain throughout the authorised shelf-life.
 Ensuring that existing control methods are satisfactory.
 Investigating the Not of Standard Quality (NSQ) Product.
 Identifying Unapproved Products/ Without License sales outlets.
 Identifying Spurious drugs in distribution chain
 Identifying sales outlets where repetitive NSQ/ Spurious drugs are reported etc

Click here to read the Circular

Source: https://cdsco.gov.in/opencms/opencms/en/Home/

Industry Update – Program by KIHT

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International Fellowship on Health technology assessment by
KIHT,Visakhapatnam

The 9th International Fellowship on Health technology assessment is being launched by Kalam Institute of Health Technology, Visakhapatnam, to promote the advancement of knowledge and expertise in health technology assessments.

KIHT aims to equip participants with the latest methodologies, best practices, and insights in HTA, empowering them to become leaders in the field.

The 9th International Fellowship on Health Technology is scheduled on 18th to 24th March 2024 at Kalam Convention Center,AMTZ Campus, Visakhapatnam

Program Details are given below:

Date   :  18 – 24 March 2024
Time  :   9.30 am to 5.30 pm
Venue:   Kalam Convention Center C/o AMTZ Campus, Visakhapatnam,Andhra Pradesh- 530031

Program Benefits :

– Conceptual Mastery in HEOR
– Exclusive Insights into Emerging Trends in HEOR
– Proficiency in cutting edge HEOR software
– Access to exclusive Research and Training materials
– Practical knowledge in Study design, Evidence synthesis and Economic modelling
– Exposure to Real world evidence, case studies and applications
– Open discussion with Academicians and Industrial Leaders
– Benefits of mentorship from World renowned Professionals in the field
– Global Networking Precision

Who should attend?

– Healthcare Policy makers and Regulators
– Medical Professionals and Practitioners
– Health Economist and Researchers
– Healthcare Industry and Innovators
– Academicians and Students
– Hospital Administrators

For Fee and other queries: Visit: https://kiht.in/

Contact:
Ms. Kaviya Jeyaram
kaviya.j@kiht.in
+91 8220025552

Mr. Nitturi Naresh Kumar
n.nareshkumar@ibsc-amtz.in
+91 8897330990

Click here to view Agenda

source :https://kiht.in/

Industry Update – QMSR for Medical Devices

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Quality Management System Regulation (QMSR) for Medical Devices

The Quality Management System Regulation (QMSR) for Medical Devices, released by the FDA on January 31, 2024, is a significant update to the existing Quality System (QS) regulation (21 CFR Part 820). This new rule aims to:

Harmonize with international standards, specifically the ISO 13485:2016 standard for medical device quality management systems. This will streamline processes for manufacturers who export to other countries.

Modernize the requirements, reflecting best practices in quality management and aligning with current technologies and approaches.

Increase flexibility for manufacturers, allowing them to tailor their quality systems to their specific needs while still meeting essential safety and effectiveness requirements.

Key points of the QMSR:

Incorporation by reference of ISO 13485:2016: This means that manufacturers can largely follow the ISO standard to meet the FDA’s requirements, with some additional clarifications and modifications outlined in the QMSR.

Focus on risk management: The QMSR emphasizes a proactive approach to identifying and mitigating potential risks throughout the product lifecycle.

Quality by design: The QMSR encourages manufacturers to build quality into their products from the start, rather than relying on inspections and testing to catch problems later.

Increased transparency: The QMSR requires manufacturers to maintain more comprehensive documentation and make certain information available to the FDA upon request.

Important dates:

Publication date: January 31, 2024

Effective date: February 2, 2026

The rule is effective two years after publication in the Federal Register. Until then manufacturers are required to comply with the QS regulation. The FDA will begin to enforce the QMSR requirements upon the effective date, February 2, 2026.

Source: https://www.fda.gov/

Carbon Credit Trading Scheme 2023

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Carbon Credit Trading Scheme 2023: Summary and December 2023 Amendments

Original Scheme (June 2023):

Objective: Establish a domestic carbon market to incentivize greenhouse gas (GHG) emission reduction and removal in India.

Compliance Mechanism: Entities exceeding designated emission intensity benchmarks must surrender carbon credits or pay penalties.

Credit Issuance: Entities undertaking projects that reduce or remove GHGs (e.g., renewable energy, afforestation) could get certified carbon credits.

Trading Mechanism: Initially limited to compliance market, allowing entities to buy and sell credits for compliance purposes.

Implementation: Phased approach, starting with specific sectors and expanding gradually.

Key Amendments (December 2023):

Introduction of “Offset Mechanism”: Allows non-obligated entities to register projects for generating carbon credits through voluntary emission reduction or removal activities.

Expanded Scope: Bureau of Energy Efficiency (BEE) to recommend sectors and methodologies for credit generation under the offset mechanism.

Project Validation: Emphasized importance of robust validation process for projects registered under the offset mechanism.

Steering Committee: Membership expanded to include diverse stakeholders.

Impacts of Amendments:

a.Increased opportunities for entities to generate and trade carbon credits beyond mere compliance.

b.Potential to attract more investments in green projects and accelerate India’s climate goals.

c.Enhanced transparency and credibility of the scheme through strengthened project validation.

d.Broader stakeholder involvement in scheme governance.

Additional Notes:

The scheme is still under development with specific details like credit pricing and trading platform yet to be finalized.

The success of the scheme will depend on effective implementation, robust monitoring, and ensuring environmental integrity of credits.

This summary provides a general overview. For deeper understanding, refer to official documents and news articles

Click her to read the Original Notification

Source:https://beeindia.gov.in/sites/default/files/CCTS.pdf

Click here to read the amendment to original notification

Source:https://beeindia.gov.in/sites/default/files/CCTS%20Notification.pdf

Gen – AI – IMF report

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Gen-AI: Artificial Intelligence and the Future of Work

The IMF staff discussion note, “Gen-AI: Artificial Intelligence and the Future of Work” provides a comprehensive analysis of the impact of AI on labor markets globally.  Key points of the report are shared below :

Artificial Intelligence (AI) has the potential to reshape the global economy, especially in the realm of labor markets.

Advanced economies will experience the benefits and pitfalls of AI sooner than emerging market and developing economies, largely due to their employment structure focused on cognitive-intensive roles.

There are some consistent patterns concerning AI exposure, with women and college-educated individuals more exposed but also better poised to reap AI benefits, and older workers potentially less able to adapt to the new technology.

Labor income inequality may increase if the complementarity between AI and high-income workers is strong, while capital returns will increase wealth inequality.

However, if productivity gains are sufficiently large, income levels could surge for most workers. In this evolving landscape, advanced economies and more developed emerging markets need to focus on upgrading regulatory frameworks and supporting labor reallocation, while safeguarding those adversely affected. Emerging market and developing economies should prioritize developing digital infrastructure and digital skills

Click here to read the IMF report

NSW portal for Medical Devices

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Launch of 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

Guide book on How to apply for CDSCO approval

Source:https://cdsco.gov.in/opencms/opencms/en/Home/

National Single Window System

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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/

Electronic Export Documents

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Transition to Electronic Export Documents

The U.S. FDA’s Center for Devices and Radiological Health (CDRH) has transitioned from paper to electronic export documents for medical devices.

Starting January 2, 2024, certificates like CFG, COE, and NCR will be electronically issued as downloadable PDFs via CECATS.

Recipients have 45 days to access and print the document.

Verification can be done through the FDA’s FECV system using a QR code, and certificates remain valid for 2 years.

Electronically issued documents include:

  • Certificate to Foreign Government (CFG);
  • Certificate of Exportability (COE) under section 801(e)(1) or 802 of the Food, Drug, and Cosmetic Act (the FD&C Act);
  • Non-Clinical Research Use Only Certificate (NCR);
  • Certificate to Foreign Government for Device Not Exported from the United States (CFG-NE); and
  • Export Permit Letter

Any queries regarding electronic export documents for medical devices, please email to Exportcert@cdrh.fda.gov.

Source: https://www.fda.gov/medical-devices/industry-medical-devices/transition-electronic-export-documents-letter-industry

Announcement from NABH

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QUALITY SETU

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/

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