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

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
  • Quality control
  • Quality Assurance
  • Registration and regulatory consultants
  • Medical Device packaging companies
  • Solutions 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

  • Detailed updates on the regulation and approval of Medical Devices and IVDs
  • Take away an in-depth understanding of the registration requirements and expectations
  • Essential updates on post market surveillance and vigilance reporting
  • Examine IVD registration requirements and expectations across the region and learn how to successfully meet these in practice
  • Understanding the EUMDR, requirements and expectations
  • Discover country specific labelling requirements and ensure you remain compliant to changing expectations

GLIMPSES FROM PREVIOUS EDITION

Conceptualized By