हिंदी
Registration of Medical Devices mandatory from 1st June 2022
Virtual Session
Amritsar 17 March 2022
PHD Chamber of Commerce and Industry (PHDCCI) organized second in the series, Interactive Video Conference Series on MDR 17 – Regulation of Medical Devices on Relevance of Voluntary Certifications in Medical Devicesto apprise participants on Role of Voluntary Certifications in Medical Devices Sector; ISO 13485 Medical Devices Standard Certification & Implementation; Risk of Unauthentic Certification in Manufacturing; Indian Certification for Medical Devices (ICMED) Scheme & address the Challenges faced by Medical Devices manufacturers.
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Col. Rajiv Bhargava (Retd.), Associate Director, Indian School of Business, Mohali welcomed all the distinguished speakers and participants. While moderating the session, he emphasised the significance of regulatory requirements in the medical field, with a particular focus on accessibility and safety.
Mr.SuvratKhanna, Co-Chair, Chandigarh Chapter, PHDCCI while delivering the welcome remarks stated that there was a need of Safety, risks, effectiveness and performance of the medical devices to be well established and regulated properly.He also informed that Registration of Medical Devices is mandatory from 1st June 2022.
Dr.Anil Kumar Gupta, Professor & Head, Administration, PGIMER mentioned Medical Device Sector has a lot of promise and regulatory certification is critical for the sector’s proper operation as Quality Healthcare needs Quality Medical Devices.
Mr. Anil Jauhri, Former CEO, National Accreditation Board for Certification Bodies (NABCB), New Delhi made detailed presentation on role of voluntary certifications in medical devices sector. He informed that MDR 2017 does not require any certification – only compliance to BIS standards and audit – by notified bodies for cl A & B – by regulator for cl C & D. He further stated that if domestic regulations are not at par with global regulations, extra effort is required to be made by industry – to show compliance to higher standards in global market. He suggested Govt. could install an institutional voluntary system to certify to foreign/international standards and take comprehensive view of the quality ecosystem.He also mentioned ICMED 13485 plus scheme of QCI could be such a system.
Mr. T. Karthi, Lead Consultant, Nucleus Consultants, Chennai took a deep guide into the ISO 13485 via apprising the participants with definition & certification requirement process. He emphasised on requirement of risk based approach in Quality Management System. Besides, illuminated the audience on how to manage risk effectively in medical sector.
Mr. Mrutunjay Jena, Scientist G & Head- Accreditation and Training, Andhra MedTech Zone Ltd (AMTZ), Visakhapatnam made a well laid talk on what Industry needs to know on how to avoid unauthentic certificates. Additionally, he illuminated various issues in obtaining certification such as conflict of interest, integrity & ethics and Audit issues besides showing examples of unaccredited certificates.
Mr. C.S. Sharma, Joint Director, Quality Council of India, New Delhi briefly explained ICMED 9000, ICMED 13485 & ICMED 13485 Plus Certification Schemes & elaborated on how to drive Voluntary Certifications within the Compliance Ecosystem In India. He apprised further on Design, Development and Implementation of Voluntary Schemes, Certification Criteria for Product Certification and various Voluntary Schemes designed by PADD & QCI.
Mr. Umesh Sharma, Head, Quality Assurance & Regulatory Affairs, Meril Life Sciences Pvt. Ltd., Chala, Gujarat gave Industry perspective on ISO 13485: Medical devices — Quality management Systems — Requirements for Regulatory Purposes. He shared complete roadmap to implement ISO 13485. He also talked about the challenges involved and suggested corrective steps to overcome & eliminate challenges involved.
Mr. Mayank Saini, Manager HME-Regulatory Affairs, Samsung India Electronics, New Delhi shared his views on specific challenges in terms of QMS and Regulatory challenges in terms of implementation.
Mr. Bansi Mahajan, Member, Managing Committee, IMDIM Association, Mumbai, while highlighting issues confronting non-sterile instrument manufacturers, proposed simplifying the certification process by grouping non-sterile instruments into one category and replacing ISO 13485 with a simplified version of ISO Certificate.
Mr. SuvratKhanna, Co-Chair, Chandigarh Chapter of PHDCCI thanked all the esteemed speakers for taking out time for disseminating knowledge on such a pertinent topic.
More than 100 participants including Policy makers/Government organizations, Medical Devices Manufacturers, Medical devices Procurement agencies/organizations, Medical devices testing, Quality monitoring organizations, Associations of Industry, Professionals from Pan India attended and benefited from the programme.
