[Webinar] China Regulatory Updates Of Q1/2022 & Tips For Medical Device Registration Under Covid

Topic: China Regulatory Updates of Q1/2022 & Tips for Medical Device Registration under Covid

Date: Wednesday, April 27, 2022, 8:00-9:00 AM Pacific Time (US and Canada)

As we entered year 3 of the Covid pandemic, China medical device market continues to be attractive and competitive for many manufacturers globally. A total of 3,228 Class II and 3, 689 Class III products were approved by NMPA in 2021, showing an increase of 5.9% and 11.4% respectively compared with 2020, and these numbers are expected to go up again in 2022.

From the regulatory perspective, the implementation of Order 739 has triggered many key regulations and guidelines updates/release down the stream. Some key updates have already forced medical device manufacturers targeting the Chinese market to reformulate their regulatory & clinical strategy.

BradyKnow offers this webinar to help medical device professionals keep up with the major regulatory updates for medical device registration/compliance in China for the first quarter of 2022. You will also learn some tips for running successful medical device registration projects in China under the pandemic.

Agenda:

• Major regulatory updates for China medical devices in the first quarter of 2022 including:
  • The 2022 National sampling inspection for the quality of medical devices
  • SaMD/SiMD software registration and newly revised guidelines for AI, and cybersecurity
  • Newly revised China GCP
  • China local production (e.g. contract manufacturing)
  • List of newly released product-specific guidance documents
• Tips for medical device manufacturers for running projects in China under the Covid including:
  • Type testing
  • Clinical studies
  • NMPA communications

Registration Link:

https://us06web.zoom.us/webinar/register/WN_luauRQbcSkGXlHWOCt7-MQ

Speaker:

Tracy Yu

Senior Project Manager, BradyKnows Medical

Tracy has over five years of experience as a project manager for NMPA medical device registration, strategy, testing, and clinical evaluation. She has master’s degrees in Biotechnology and Regulatory Affairs and working experience in clinical operations and pharmacovigilance at multiple international CRO companies.