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

4th ANNUAL MEDICAL DEVICE REGULATORY AND QUALITY SUMMIT 2019

The existing regulatory framework for the medical devices in India is inadequate for the USD 6 billion Industry. Medical Devices were unregulated in India until recently. The first draft of the Medical Device rules came in existence in 2016 and after consulting the industry and stakeholder, as second draft if the draft was issued in October 2016 and later in January 2017. The 2017 draft has been effective from January 2018, thereby giving the industry time to adapt to the new rules. The rules framed around the guidelines of the Global Harmonization Task force (GHTF) ensure that the Indian norms governing medical devices are on par with those in vogue globally. Medical devices, henceforth, both produced and imported, will conform to the best international practices o manufacturing, ensuring the prevalence of quality products in India. The industry, which is been growing at a rapid pace, hence the need for clarity on regulations, export and import guidelines is essential for the Industry.

The 4th Annual Medical Device Regulatory and Quality Summit 2019 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 4th Annual Medical Device Regulatory and Quality Summit 2019 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.


SPEAKERS

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KEY CONFERENCE FOCUS AREAS

  • Changes and advancements in Regulations
  • Regulatory Framework and Implementation
  • Restructuring Strategies
  • Risk Management
  • Regulatory implications on medical device packaging
  • Quality control procedures, techniques and norms

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

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