FDAnews Webinar: Latest Regulatory Updates with QMS-PMS Focus


Tuesday, Jan. 21, 2020, 11:00 a.m.-12:30 p.m. EST

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The National Medical Products Administration (NMPA) — formally known as the China Food and Drug Administration — has introduced hundreds of new regulations that affect the complete product life cycle of medical devices, from new submissions to product changes.

How can manufacturers, inventors, and investors be prepared to shorten their time to market for new submissions, allow enough lead time for renewal as well as to know when to file for modifications to avoid penalties?

Join us on Jan. 21 and get up to speed on the regulatory reform in China that impacts medical device and in vitro diagnostic (IVD) industry and get answers to key questions:

  • What are the new post-market surveillance (PMS) regulations and implications in adverse events and recalls reporting? Are your sales channels or distributors meeting the China good supply practices (GSP) and distribution requirements?
  • For overseas manufacturers, what the regulations and requirements for overseas inspections?  How can you be prepared for it? 
  • If you have suppliers in China, what are the China good manufacturing practices (GMP) requirements? What are the common issues?
  • For the first time in China, the piloted Marketing Authorization Holder (MAH) system allows the separation of the manufacturing entity from the product design entity for domestically made devices, can you leverage it?

During the webinar, you’ll:

  • Determine how to leverage a legal agent in China to increase your compliance by understanding their roles and responsibilities
  • Discover how to assess and determine the new piloted MAH system by understanding its MAH qualification requirements and responsibilities
  • Familiarize yourself with how to leverage your overseas QMS for your China operations by understanding China GMP regulations and Chinese culture differences
  • Find out how to comply with required adverse events (AE) and serious adverse events (SAE) reports, including how to differentiate between AE and SAE and when to report

Join us for clarity on China’s regulatory reforms impacting the medical device and IVD industry. Click here to learn more and register.

Who Will Benefit

  • All medical device and IVD companies, inside or outside of China Start-ups who want to go to China
  • Investors and equity firms
  • Quality
  • Compliance
  • Inspection and audit
  • Regulatory affairs professionals
  • Clinical affairs professional
  • Product managers
  • R&D managers
  • Marketing managers

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