Reviewing regulatory and quality landscape in the medical device industry and looking at specifications in the evolving regulations to create a strong and compliant framework within the organization

5th Annual Medical Device Regulatory and Quality Summit 2021

India is among the top 20 markets for medical devices worldwide. India's medical devices market stood at US$ 11 billion in 2020 and is expected to reach US$ 65 billion in 2024. The Government of India (GOI) has commenced various initiatives to strengthen the medical devices sector, with emphasis on research and development (R&D) and 100% FDI for medical devices to boost the market. From April 2000 to March 2021, FDI inflow in the medical and surgical appliances sector stood at US$ 2.19 billion. By 2025, the Indian market for medical equipment is predicted to increase from US$ 11 billion to ~US$ 50 billion. The Indian medical devices sector is estimated to be worth ~US$ 10 billion in 2021.

The 5th Annual Medical Device Regulatory and Quality Summit 2021 will create a platform for regulators, industry stalwarts to come under one roof to discuss and share ideas that would not only benefit their organisations, but at large the industry as well. The conference will review the evolving regulations, their impact on the industry as well as take an in depth look into areas of quality control and assurance.


THOUGHT LEADERS

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KEY CONFERENCE FOCUS AREAS

  • Regulatory changes for medical device companies and the impact of COVID-19 on manufacturers
  • MDR overview - Main regulation changes, challenges you will meet during transition and strategies for their overcome
  • Medical devices reclassification based on new requirements; New classification rules
  • Medical device outsourcing and new foreign trade problems for import/ export business
  • Growth trends in the different medical device markets in India and round the world

COUNTRIES

WHO SHOULD ATTEND?

  • Government Authorities
  • Medical Device manufacturers
  • Medical Device distributors
  • Registration and regulatory consultants
  • Medical Device packaging companies
  • Solution Providers

FROM WHICH DEPARTMENT?

  • Legal & Regulatory Affairs
  • Government Affairs
  • Product Regulations
  • Quality Control & Assurance
  • Research & Development
  • New Product Development
  • Licensing
  • Packaging and Labelling

KEY TAKEAWAYS

  • Understand detailed updates on the regulation and approval of Medical Devices and IVDs
  • Roadmap to remote regulatory assessment in the post pandemic world
  • Insights on regulatory training, standards and guidance
  • Exploring Artificial Intelligence in medical device
  • Managing labelling requirements and ensure you remain compliant to changing expectations
  • Deep dive sessions on compliance and strategic priorities
  • How to build and bring innovative devices to market
  • Exploring new ways to protect data and privacy
  • Impact of the pandemic on Imports/Exports
  • Leverage on this golden opportunity to meet and connect with regulatory bodies and industry experts

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