Interactive Video Conference on Understanding ISO 13485 Certification for Medical Devices
Chandigarh Chapter, PHDCCI is organizing 5th in the MDR-17 Series| Interactive Video Conference on Understanding ISO 13485 Certification for Medical Devices as per the following schedule:
Day & Date: Friday, 15 July 2022 Time: 2:30 pm to 5:00 pm Platform: Zoom
• 7 Basic Quality Management Principles • Overview of the Certification process and • Importance of 13485 Certification from Compliance perspective
• Mr. Mahadevan. J, VP & Business Segment Head – Medical, DQS India- Deutsch Quality Systems (India) Private Limited, Kodihalli, Bengaluru • Mr. M G Sathyendra, Consultant & Trainer – Global Certifications, Qmart Global, Yeshwantpur, Bengaluru • Mr. P.K.Minocha, Director, Meril Life Sciences Pvt. Ltd., Chala Gujarat • Mr. Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AIMED), New Delhi • Col. Rajiv Bhargava(Retd.), Associate Director, Indian School of Business, Mohali
Industry, Startups & Innovators Support Session with Regulators on Licensing Requirements for Medical Device Manufacturers, Startups & Innovators in Tamilnadu – MDR 17
Session Topic : Ease Of Doing Business – Industry & Startups Support Session on Licensing Requirements – MDR 17
Date : 23rd July 2022 Saturday Time : 3 pm – 5 pm Meeting : Online Meeting
Program Objective: Medical Device Industry in India is brought under full regulatory purview and industry has to show compliance to the Regulatory announcements made to this effect, from time to time.
Operators dealing with Risk Category Class A and B devices come under the purview of State Licensing Authorities and those dealing with Risk Category Class C & D devices come under the purview of Central Licensing Authority.
Medical Device Manufacturers, Innovators, Startups of Tamilnadu have requested for interactive sessions with Central and State Licensing Authorities and other stakeholders like BIS etc to guide them to implement the regulatory requirements better.
AIMED which is the voice for Indian Medical Device Manufacturers in the country and NHHID – Anna University , a National Hub for Healthcare Instrumentation Development, and Bureau of Indian Standards have collectively agreed to organize periodical sessions for the benefit of the industry and startups, innovators of Tamilnadu.
Medical Device Manufacturers, Innovators, Startups in Medical Device, MedTech space, Academia, Technology Business Incubators, Innovation Hubs, Medical Device Testing Laboratories, Healthcare services organisations – Hospitals, Diagnostics Centers , and other healthcare businesses, stakeholders to Conformity Assessment, Government organizations etc from Tamilnadu
Session would be conducted as Online Meeting, an interactive engagement with Manufacturers, Innovators, Startups .
There is NO REGISTRATION FEE. However , prior registration is a must.
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
Accreditation: Sustainability in Economic Growth and the Environment, focuses on how accreditation supports the United Nations Sustainable Development Goals – (SDGs) 6, 7, 8, 9, 11, 12, 13, 14, 15.
#WAD Celebrations – an annual initiative from Consultants Consortium of Chennai (CCC)
CCC has been organising series of Knowledge Sessions for the benefit of the industry during WAD Month since its inception. WAD 2020 and WAD 2021 were well received by the industry. We had conducted virtual learning sessions during this period.
WAD 2022, however would be a Hybrid Session. We are planning to organise a physical session in University Auditorium in Chennai with a target audience of around 100 -150 members (offline) and plus online viewers.
IASis a nonprofit, public-benefit corporation that help organizations demonstrate compliance and competence to their customers, regulators and the public. IAS has been providing accreditation services since 1975. IAS accredits a wide range of companies and organizations including governmental entities, commercial businesses, and professional associations. IAS accreditation programs are based on recognized national and international standards that ensure domestic and/or global acceptance of its accreditations.
IAS also maintains signatory status in a number of global multilateral recognition arrangements under Asia Pacific Accreditation Cooperation (APAC), International Accreditation Forum (IAF) and International Laboratory Accreditation Cooperation (ILAC). IAS is a member of the ICC Family of Solutions.
As one of the leading accreditation bodies in the United States, IAS is a signatory to the three primary international organizations that form a unified system for evaluating and recognizing competent accreditation bodies worldwide.
Bureau of Indian Standards
BIS is the National Standard Body of India established under the BIS Act 2016 for the harmonious development of the activities of standardization, marking and quality certification of goods and for matters connected therewith or incidental thereto. BIS has been providing traceability and tangibility benefits to the national economy in a number of ways – providing safe reliable quality goods; minimizing health hazards to consumers; promoting exports and imports substitute; control over proliferation of varieties etc. through standardization, certification and testing
Keeping in view, the interest of consumers as well as the industry, BIS is involved in various activities as given below:
Standards Formulation Product Certification Scheme Compulsory Registration Scheme Foreign Manufacturers Certification Scheme Hall Marking Scheme Laboratory Services Laboratory Recognition Scheme Sale of Indian Standards Consumer Affairs Activities Promotional Activities Training Services, – National & International level Information Services
Conference Theme :
Sustainability in Economic Growth and the Environment -How accreditation supports the United Nations Sustainable Development Goals (SDGs) 6, 7, 8, 9, 11, 12, 13, 14, 15.
Conference Sessions are built for multiple sectors touching upon the Sustainability Initiatives in various sectors and applicability of various Standards, Certifications, Accreditations , Regulations to ensure that Sustainable Products and Services are offered to Consumers.
Sustainability is a Trade Issue and World Markets are linking World Trade to Sustainability initiatives adopted by various countries.
ESG is based on standards set by lawmakers, investors, and ESG reporting organizations (e.g., GRI, TCFD, MSCI), whereas Sustainability Standards — while also set by standards groups like GHG Protocol — are more science-based and standardized.
Dates : June 9th and 10th 2022 – Thu & Fri Time – 10 00 am – 5 45 pm IST Session Mode – Hybrid (Online and Physical) Venue – Auditorium inside Anna University Campus
Who should attend ?
Sessions would be open to Accreditation Bodies, Certification Agencies, Conformity Assessment Bodies, Inspection bodies, Govt organisations, Members of Trade & Industry Associations, Chambers of Commerce, Entrepreneurial Hubs, MS Consultants, Technical Experts, Startups, Innovators
Sessions at a glance :
Program Agenda Day 1 – Inaugural Session
Open to all stakeholders in Conformity Assessment.
Industry, ABs, CBs, CABs, Inspection bodies, Consultants, Technical Experts, Industry Associations, Innovators, Start-ups, Entrepreneurial Platforms, Government organisations.
There is NO REGISTRATION FEE
However prior registration is a must for participation.
Medical Device Regulations – Non Notified Devices – Voluntary Registration Process – September 19th 2021, Sunday – 4 PM – 5 PM
Let Our REGULATORSpeak to You !
Do Join Us to get answers to your FAQs on Voluntary Registration Process !
Voluntary Registration Process rolled out by CDSCO for Non Notified Devices is coming to an end by Sep 30th 2021. Industry Forums are receiving so many FAQs from various stakeholders over the last 2 months asking many questions on Voluntary Registration Process and raising wide range of questions on WHAT HAPPENS FROM OCTOBER 1ST 2021.