Suzhou International Expo Centre

Medtec Innovation Suzhou

2024.12.23-24 | B1 Suzhou International Expo Centre

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Quality Track B:How to comply QSR with FDA regulatory requirements








MDiT Forum and Regulation Summit 2024—— Quality Track B: How to meet the quality requirements of products in overseas markets under the epidemic situation

Co-organizers: Medtec China



Conference Background:

As the global New Crown epidemic draws to a close, what new regulatory measures have been developed by the FDA, the medical device regulatory authority in the United States, from the EUA program in the epidemic, and what do these regulatory measures mean for the majority of manufacturers?

Our domestic manufacturers can be roughly divided into the following categories. 

  • Manufacturers of epidemic prevention equipment already exported to the U.S. through EUA during the epidemic, such as reagents, masks, X-ray machines, etc. 
  • Manufacturers who are currently preparing to export various devices to the U.S.
  • Medical device manufacturers who were notified by FDA for inspection before the outbreak

Get up close and personal with FDA officials and senior FDA consultants to learn about FDA regulatory policies in the post-epidemic period, strategies for factory inspection compliance, ways to prepare for 21CFR820, and a peer-to-peer discussion of QSR compliance challenges.


This seminar will feature LCDR Scott Gonzalez, International Relations Specialist – Medical Devices from FDA China Office, who will present on the topic of “FDA Compliance in Testing Medical Device Quality Systems during an Epidemic. The lecture was delivered by Scott Gonzalez, LCDR (Geng Zonghao), a medical device international relations specialist from the FDA Office in China.

Due to the global epidemic, FDA Postpones Foreign Inspections Through April 2020: Considerations for Industry, including Mission-critical” inspections and Records requests “in advance”, etc. In order to address these issues, Zeli Yu continued his three-part presentation on the manufacturer’s compliance lifeline under the U.S. quality system framework.


1. QSR compliace strategy 
2. readiness for QSR compliance 
3. sample challenge point in QSR compliance inspection


Who Should Attend?

  • Medical device manufacturers: heads of export sales, regulatory, quality, production and R&D departments and projects / enterprises
  • Regulatory consulting, research and service companies on medical devices
  • Regulatory authorities and scientific research institutions of medical devices

*Conference agenda updates according to speaker confirming.


>> TBD



LCDR Scott C. Gonzalez, FDA International Program and Policy Analyst – Medical Devices, China Office




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