On-demand Webinar

The evolving regulatory landscape for In Vitro Diagnostics (IVD) in APAC region

Ms. Huang Yasha
Head Regulatory Policy (APAC)
Roche Diagnostics
Mr. Victor Tan
QA & RA Manager - ASEAN
Ortho Clinical Diagnostics
Mr. Sam Kay
Principle Regulatory Consultant
Clarivate
Mr. Raghav Tangri
Lead Healthcare Analyst (Medtech)
Clarivate

The Evolving Regulatory Landscape for In Vitro Diagnostics (IVD) in the Asia-Pacific (APAC) region is an important and rapidly developing topic that is of interest to healthcare professionals, regulatory authorities, and IVD manufacturers. The focus of this webinar on the key issues and challenges facing the IVD industry in the APAC region, including the impact of new regulations, the importance of speed to market, connectivity and data integrity, extended approvals, and AI and software regulation.

Topics covered:

  • The impact of changes in European regulations on the IVD industry in the APAC region
  • The importance of speed to market in APAC countries
  • How regulations can drive the development of certain IVD product types
  • Connectivity, integrity and data in the IVD industry. in APAC
  • The use of data from existing products or tests to obtain extended approvals for new IVD products
  • AI and software regulation in the APAC region.

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