Expert Presentation 4

Shri Rajiv Nath
Managing Director, Hindustan Syringes & Medical
Devices Ltd & Forum Co-ordinator - AiMeD

Indian Certification For Medical Devices : ICMED Certification

Mr Rajiv Nath highlighted the need to have smooth and well defined regulatory pathway for the industry to have smooth transition. Well defined and implemented regulatory framework will enable the ease of doing business for the industry too. Industry will attract fresh investments into the sector only if there is a well defined and clear regulatory framework. Lack of well defined regulatory environment is the reason why med dev industry did not attract investments into this segment over the last 10-20 years. Mr Rajiv Nath has recalled how the regulatory framework in the country has evolved since 1989 and how the changes were taking place in regulatory space. He highlighted the need to encourage Make in India and not to discourage investments in this sector and this is possible to have more clarity and well defined regulatory structure. Med Dev Industry has welcomed the Regulations and always is of the opinion that well defined regulatory mechanism will attract investments into this sector. He touched upon the need to separate laws for Drugs , Devices and Cosmetics to bring more clarity while addressing patient safety issues. He touched upon the need to share the work load betn Central Govt, State Govts and the Conformity Assessment bodies to have an effective implementation roadmap. He emphasised upon the need to create laboratory infrastructure in the country to test all med dev in the country. All these have to be on place before the regulations get rolled out. Mr Nath highlighted about the ICMED Certification, an Indian Certification Standard created in alignment with International Standards requirements, 5 years ago by involving multiple stakeholders including MoH&FW. ICMED Certification was designed as a Voluntary Standard and mfrers implementing ICMED Certification meets compliance to MDR 2017 automatically and many more patient safety standards and other elements as well. Mr Nath concluded his speech with a wish list from the industry which includes bringing all mfrers and importers under registration mechanism by CDSCO; compliance to ISO/IS13485 Certification by industry and importers in next 2 years time; to incentivise QCI’S Voluntary ICMED Certification; Build competence of Auditors, Med Dev officers & Mfrers; create testing infrastructure with more NABL Accredited labs; expedite adaption of ISO Stds as BIS Stds; creating separate law for Medical Devices.

Expert Presentation 5

Dr Sanjeev Kumar Gupta
Managing Consultant, InTrust Consulting

Indian Medical Device Rules – Transition Period and Industry Preparedness

Dr Gupta started off his speech by highlighting the need for med dev industry to prepare for the transition to regulatory regime and why industry should be prepared to spend both time and money on this exercise. He cited how challenging this exercise would be for MSME businesses to meet the QMS & Regulatory Spec but why its inevitable as the mfrers have responsibility to produce both Quality and Safe products. He stressed upon the need for the top mgmt to keep aside good budgets for MDR & QMS implementation as budgeting is also an important exercise for the industry to have an effective roadmap towards implementation. As a Regulatory Planner and Consultant, he has listed out the regulatory compliance roadmap for various segments of industry. He has listed out the key challenges in implementing the regulatory reqts in terms of infrastructure, QMS implementation and upskilling of human resources. He has also listed out the challenges in implementing Sch 4 requirements on MDR which calls for Technical Documentation. He has concluded his speech by sharing some tips to the industry on execution roadmap and do’s and don’t’s suggestions too!

Expert Presentation 6

Mr M G Sathyendra
Founder & CEO, Q Mart Global

Global Medical Device Regulations

Safety matters and why Regulations in Med Dev space aim at addressing the same. He cited how regulations help to arrest the import of sub standard products into the country , which otherwise may put patients lives to greater risk. He touched upon the various stages of govt regulations that industry is subject too. He touched upon the common framework for regulations .He shared the regulatory systems in GFTF Countries and the role of IMDRF (International Med Dev Regulatory Framework). He discussed about the Med Dev classification and how it differs in global environment. He discussed about key regulatory requirements in key global markets . He also touched upon the role of Standards in the global regulatory regime and finally concluded the session by sharing the list of indispensable standards applicable for med dev industry across the globe.

Conclusion And Vote Of Thanks

Mrs Rama Venugopal
President, Consultants Consortium Of Chennai

Mrs Rama Venugopal, President, Consultants Consortium of Chennai has concluded the session with a vote of thanks by thanking all partners and sponsors for the session.