PHDCCI Conference

Interactive Video Conference on Preparing for Licensing Norms for Class A and Class B Medical Devices (w.r.t 1st October 2022)

Chandigarh Chapter, PHDCCI is organizing 4th in the MDR-17 Series, Interactive Video Conference on Preparing for Licensing Norms for Class A and Class B Medical Devices (w.r.t 1st October 2022) as per the following schedule:

Day & Date: Friday, 24 June 2022
Time: 2:30 pm to 5:00 pm
Platform: Zoom

Session Highlights
• Regulation of medical devices and recent amendments
• Steps to Licensing for Class A & Class B Devices/Products
• QMS requirements for Medical Devices
• Demonstrating Product Compliance as per MDR-17
• Challenges faced by Medical Devices Manufacturers

Key Speakers
• Dr. Ravi Kant Sharma, Deputy Drugs Controller, Ministry of Health & Family Welfare Government of India, New Delhi
• Mr. M G Sathyendra, Consultant & Trainer – Global Certifications
• Mr. Hemant Bhardwaj, Founder & President, Global Medical Devices Experts Foundation
• Mr. P.K.Minocha, Director, Meril Life Sciences Pvt. Ltd., Chala Gujarat
• Dr. Sanjiiiv Rehlan, Chief Executive Officer, Shalex Overseas & Member, Association of Indian Medical Device Industry (AIMED), New Delhi
• Ms. Rama Venugopal, President, Consultants Consortium of Chennai & Executive Director, Value Added Corporate Services (P) Ltd., Chennai

Please register in advance by clicking the link:
https://us02web.zoom.us/meeting/register/tZIpcuGhqT0oE9MghceheO3F_QWzn45B7CTc

You tube link of the session is also appended.
https://youtu.be/1AHq92C_F2A

You may send your questions to rimneet.kaur@phdcci.in prior to the session.
The relevant questions will be answered during the programme.

For any query, you may contact:
Ms. Rimneet Kaur, Resident Director, PHD Chamber
Mob:+91 81460 02297 | Email: rimneet.kaur@phdcci.in

Mr. Avneet Singh, Sr. Resident Officer, PHD Chamber
Mob:+91 8283848012 | Email: avneet.singh@phdcci.in

InformationUpdate

Industry Information Updates – Healthcare Sector

Medical Device Regulations

Indian Medical Device Rules 17 – Regulatory Affairs – Learning & Development Series

PWMAI – Preventive Manufacturers Association of India is creating online web series on Indian Medical Device Rules on the most frequently asked questions for the benefit of industry , stakeholders.

The Learning and Development Series will have short video sessions on wide range topics and subjects based on MDR 17.

Industry and all other stakeholders are requested to visit this page regularly for more updates, recent uploads.

TopicYoutube LinkCreated by
How to create User Registration in MD CDSCO Portal ?https://www.youtube.com/watch?v=klCBqt2akRcPWMAI
Creation of Undertaking to be uploaded in MD CDSCO portalhttps://www.youtube.com/watch?v=OYd-8BzCkck&t=33sPWMAI
What is MDR (Medical Device Rules) ?https://www.youtube.com/watch?v=Mbadl4a0DAM&t=153sPWMAI
Essential Principles for Medical Device Safety & Performancehttps://www.youtube.com/watch?v=RWPQkp_0C74PWMAI

About PWMAI

PWMAI– Preventive Wear Manufacturers’ Association of India is a team of people engaged in manufacturing of Preventive Wear products. Primary domain of manufacturers of this group is Surgical Gowns & Drapes which are used for infection control in Healthcare Settings.

Outcome of COP26 for India and Abroad

Outcome of COP26 for India and Abroad – Webinar from Service Export Promotion Council

Announcement from SEPC :

We are Organising a webinar on COP26. A business unit can sell its carbon points and gets incentives on financing and special offers in most of the member countries.

Any kind of environmental steps that a company takes is monetary benefit to them, especially if they are exporting. How to do this can be learnt through this session . Plus there will also be a session on all services and incentives by SEPC.

Registration Link

https://us02web.zoom.us/webinar/register/WN_LBV79wNvRyOaFET1oIRidQ

NABL Announcement

CLARIFICATION ON UNIQUE LABORATORY REPORT (ULR) NUMBER

Accredited testing laboratories, calibration laboratories and Reference Material Producers may note the clarification on the use of ULR number released by NABL recently.

Key Highlights about the announcement :

Government electronic Marketplace (GeM) accepts test reports issued by NABL accredited laboratories along with the products which are uploaded on the GeM portal.

Similarly for product / equipment which is to be used after calibration, the calibration certificates issued by NABL accredited calibration laboratories are accepted. RM document from NABL accredited RMP is required to be uploaded along with any (certified) reference material on GeM portal.

To authenticate the test reports / calibration certificates / RM documents, GeM has sought the co-operation of NABL in getting the data on reports mapped with the claim of the sellers. To facilitate such mapping, an 18-digit ULR number has to be mentioned on all reports issued by testing & calibration laboratories and RMPs. This number will be in addition to the report number of the laboratory / RMP and will have to be mentioned in all reports issued with accredited scope only.

This system is not mandatory for test reports issued by bulk petroleum product manufacturer’s laboratories, test reports of non-commodities like air, waste water and similar environmental parameters and results related to veterinary testing, dope testing & forensic testing.

For testing and calibration laboratories, discipline (example- Biological / Mechanical) and group (example- Water /

Dimension) as applicable needs to be mentioned before the product and parameters in the reports. (Please refer NABL 120)

For RMP, category and sub-category needs to be mentioned before the product / parameters in the document. (Please refer NABL 191).

It is reiterated that the ULR system has to be followed in line with the current version of NABL 133.

This system is not to be used in reports containing parameters outside the scope of NABL accreditation.

Read the full notification issued by NABL here :

Announcement

Announcement from NABL on CABs

Sharing the recent announcement from NABL on CABs.

There is a fast track focus at the market place to seek Certifications fast. This trend is more visible at the market place now. Fast tracking , resorting to various acts as listed in the announcement is not a healthy sign for the industry.

Certificates , Certifications are of no use, of no relevance when the users, payers, for the services don’t experience “the showcased Quality of Service”. There is a structure , methodology that needs to be followed while seeking Quality Systems Certifications.

The sudden rush for Certificates must be driving businesses to resort to unhealthy practices is what is understood from the notification !

Sharing this here to as information update for industry to take cognizance of the notification.

World Quality Month Programs

WORLD QUALITY MONTH – INDUSTRY CONNECT KNOWLEDGE SERIES – WEBINARS

Global focus on Product/Service Quality and Safety has undergone a dramatic change after the pandemic crisis across the globe.

Quality and Safety of Global Public Goods call for International Alignment of Standards, Certifications, Testing norms etc to ensure that Consumers Health, Safety and Well being is not compromised.

Responsible Production is the Global Call of Action and the it’s the Responsibility of the Global Markets to ensure Responsible Supply Chain as Consumer Welfare measure.  Global economy is moving towards Borderless Economy and many countries will have market access to global markets due to supply chain shortages. The countries which assure Authentic and Responsible Supply Chains will have strong acceptance across the globe. 

India too is seeing a huge surge in exports as well as in imports of Products and Services and how do to ensure that Consumers are assured of Quality and Safe Products and Services in domestic as well as in International Markets.

It is in this context that Consultants Consortium of Chennai (CCC) is rolling out series of Knowledge Sessions to Celebrate the November Month of Quality by connecting Industry and Stakeholders to various sessions which are the need of the hour programs.

CCC has scheduled 6 sessions spread , across the month of November, starting from November 11th 2021 till end of the month. Multiple sessions covering various sectors are scheduled.

CCC will keep communicating and inviting all stakeholders and industry to the sessions. Sessions will have the support of industry, academia, young entrepreneurs, innovators forums and various other stakeholder organizations.

This information is being shared to facilitate industry, academia, startups, Management Systems Consultants and various other stakeholders to register for the sessions . 

Sessions are conducted through Virtual Mode and there is NO REGISTRATION FEE.

SESSION 1 – NOVEMBER 11TH 2021, THURSDAY- 4 :00 PM – 5:30 PM

TOPIC – RESPONSIBLE QUALITY CERTIFICATIONS

Delegate Registration Link :

Registered Delegates shall receive autogenerated registration link from Zoom id. Please check your spam folders too if you do not receive the mail in your in box.

For further assistance , email to – contact@ccc-consultants.org

SESSION 2 – NOVEMBER 13TH 2021, SATURDAY – 4 :00 PM – 5:30 PM

TOPIC – Accessing Global Markets – Role of Private Certifications in Food Sector

Delegate Registration Link :

Registered Delegates shall receive autogenerated registration link from Zoom id. Please check your spam folders too if you do not receive the mail in your in box.

For further assistance , email to – contact@ccc-consultants.org

WORLD QUALITY MONTH SERIES – SUPPORTING BY INDUSTRY ASSNS, CHAMBERS

NABL Announcement

NABL Announcement for Calibration Laboratories

Guidelines for Interlaboratory Comparison for Calibration Laboratories where Formal PT Programs are not available
Posted on 25.10.2021

NABL has released guidelines for ILC for Calibration Labs where PT Programs are not available.

The guideline is for the Calibration laboratories which are accredited and applicant to NABL. Calibration laboratories shall participate in Proficiency Testing Program of accredited Proficiency Testing Providers. This procedure is be used only as an alternative in the absence of formal Proficiency Testing programs to meet the requirements of NABL 163.

For more information, download the document here :

Source : https://nabl-india.org/

For Clarifications and guidance , reach out to :

A A Srinivasan, Principal Consultant – srinivasanaa@valueaddedin
Mobile – +91 98404 90368

Medical Devices Webinar

Shaping India’s Medical Devices Regulatory Framework: Global Best Practices and Priorities

India’s medical devices industry is poised for significant growth in the next five years, with the market size expected to reach $50 billion by 2025. It includes both large multinationals and small to medium enterprises (SMEs), and it is growing at an unprecedented scale: its current market size is estimated to be nearly $10 billion. 

TIC Council fully supports the crafting of a robust medical devices rules regulatory and policy framework which lays a strong foundation towards ensuring a robust quality and conformity ecosystem for medical devices in India. 

In the healthcare sector, patient and operator safety are of paramount importance, which makes it imperative for medical devices to be of high quality and safe for their intended use, therefore a rapidly evolving medical device industry needs hand holding from all stakeholders, in order to be able to realize the government’s vision of quality and affordable healthcare for all. 

Embarking on the mission of patient safety in India, TIC council is organizing a two-day webinar on Shaping India’s Medical Devices Regulatory Framework: Global Best Practices & Priorities. The webinar will witness the presence of senior policy makers from Ministries & regulatory bodies of India, E.U & U.S along with senior industry leaders from the medical devices and TIC industry, sharing their experience, global trends and best practices towards ensuing quality and safety of medical devices. This webinar is a must-attend for industry leaders, decision makers, quality, regulatory and public affairs personnel from the healthcare sector.

Details 

The webinar will be held in two days: Thursday 28 October 2021, 14:30-17:00 IST (11:00-13:30 CET), and Friday 29 October 2021, 14:30-17:00 IST (11:00-13:30 CET)

Registrations will be open to all TIC Council Members and relevant stakeholders, as well as a larger external audience. 

Speakers: 

Day 1:  

  • Suresh Sugavanam, Chairman, TIC Council India
  • Hanane Taidi, Director General, TIC Council
  • Niranjan Nadkarni, CEO, TÜV SÜD South Asia, South East Asia, Middle East & Africa Region
  • Karthik Venkataraman, Business Manager, UL India
  • Claire Dyson, Global Vice President, Dekra
  • Kimberly Trautman, Medical Device, IVD and Combination Product Regulatory & Quality Expert
  • Latika Vats, Director, Regulatory Affairs & Quality Assurance for India Medtronic and APAC Med Committee
  • Reinaldo Figueredo, ISO-CASCO Chair
  • Sudhir Zutshi, Chair, Public Affairs, Sub Committee, TIC Council India

Day 2: 

  • Dr. R P Singh, Secretary General, QCI
  • Dr. Shailendra Singh, TUV SUD Pvt Ltd.
  • Jitendra Sharma, Managing Director and CEO, AMTZ
  • Ravi Kant, DDC, CDSCO (TBC)
  • Rajesh Maheshwari, CEO, NABCB
  • Ravi Singh, Member, TIC Council, Med Device WG
  • Dr. Girdhar Gyani, Director General, AHPI
  • Harshit Thakkar, Sr. Project Manager, DEKRA
  • Sudhakar Mairpadi, Head Quality, Regulatory and Govt Affairs, Philips India Pvt Ltd
  • Rajiv Nath, Forum Coordinator, AiMED
  • Vibhav Garg, Director-Health Economics & Govt Affairs, Boston Scientific
  • R Asok Kumar, Chairman, Regulatory Sub Committee, Adva Med
  • Dr. Aparna Dhawan, Executive Director, TIC Council India

REGISTRATION

Further Details:

The microphone function will be disabled for participants during the webinar but all questions for the presenter can be submitted through Webex via the chat function during the Q&A session at the end.

For further questions, please do not hesitate to contact – secretariat@tic-council.org

We look forward to welcoming you and/or your colleagues. 

For more information – https://tic-council.idloom.events/shaping-india-s-medical-devices

Global Services Conclave

Global Services Conclave 2021 – India Serves: Exploring Potential Growth Sectors Beyond IT/ITes

Global Services Conclave 2021
“India Serves: Exploring Potential Growth Sectors Beyond IT/ITes”
10.00 AM-4.30 PM, Tuesday, 9th November 2021
New Delhi, Delhi 110021

The service sector has invited considerable interest among policymakers for its larger contribution to global output, contributing almost more than three-fifths of global GDP and about half of the employment opportunities across the world.

India’s service sector is no exception to the global service composition as its share is over 60 per cent of the national output. India has emerged as a global hub for the supply of various services, and today India exports over $200 billion of services annually, which contribute to 7% of India’s GDP. Services account for 54 per cent of India’s Gross Value Added (GVA) and account for more than 40 per cent of India’s total global exports. Services exports lead directly to the employment of approximately 2.6 crores people in India while leading to indirect employment as well.

Despite the pandemic, the sector has shown immense resilience and services exports stood at $ 206 billion in 2020-21 showing a decline of only 3 per cent. Throughout the decade (2010 to 2021) the CAGR of the services sector has been 6%. Based on trends and present performance of the sector SEPC has projected a target of $250 bn for services exports in the FY 2021-22 and a target of US$ 1 trillion including IT and ITES by 2030 as suggested by the Ministry of Commerce and Industry, Government of India.

In the above context, SEPC is organising its first Global Services Conclave on 9th Nov 2021 which will be an annual feature of SEPC henceforth.

The Conclave will focus on deliberations and discussions to create a roadmap to achieve the projected target. While there will be talks on key service sectors, the focus will be on capacity building, enhancing competitiveness, MSME support, creating jobs, policy recommendations and more.

Looking forward to your participation as our distinguished Sponsor for this prestigious event. Please find attached the presentation on Sponsorship.

For any collaborations, sponsorship enquiries, please reach out to:

Mr Vikrant Wadhera +91 9910316373
Email – Vikrant.wadhera@servicesepc.org

Register for the Program Here :