[Webinar] Revisiting 2022 And Looking Into 2023: Regulatory Updates For Medical Device Market Access In China

Schedule:

Description:

Medical device manufacturers who are dedicated to bringing their products to the Chinese market may need to update and modify their market access strategies on a yearly basis to accommodate the dynamically changed China regulations and requirements.

In 2022, we witnessed many regulatory updates such as the newly revised China GCP and GMP, medical device category adjustment, etc. We also learned lessons about from the released NMPA inspection results and achieved more approvals with real-world data. In this webinar, BradyKnows Medical will provide you with a comprehensive summary of those key updates from the scope of the entire medical device lifecycle in China.

Following the key changes in 2022, BradyKnows Medical will also provide you with some tips and guidance on how to develop practical strategies in 2023 to facilitate your China market entry.

The proposed agenda is as follows:

• 2022 key regulatory updates for the entire medical device lifecycle in China, such as clinical evaluation, NMPA inspections, classification catalogue, UDI, and new registration requirements.
• Newly issued and revised guidelines and guidance documents in 2022
• Expected regulatory updates and key implementations in 2023
• Tips on how to make practical market access strategies in 2023

Registration Link:

https://us06web.zoom.us/webinar/register/WN_u9__SLdPRQmxvD9YImLNpA

Speakers:

Mike Zhu, PhD

Vice President of Medical/Clinical Affairs, BradyKnows Medical

Dr. Zhu has over ten years of experience as a researcher and regulatory/medical/clinical affairs leader at leading global medical device companies. He has extensive experience in global clinical evaluation, including EU MDD/MDR CER, China CER, TGA CER, etc.

Tracy Yu

General Manager & Senior Project Manager, BradyKnows Medical

Tracy Yu is a versatile regulatory and clinical research professional with nearly a decade of expertise. Her responsibilities include the development of regulatory and clinical strategies and management of pre-market approval projects from planning to completion, covering type testing, clinical trials/CER, consultation meetings with China NMPA reviewers, and post-market inspection and China localization projects.