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Navigating Medical Device Lifecycle and Compliance in China
January 17 @ 2:00 pm - 3:00 pm
Session 1:
Explore the intricate product lifecycle of medical devices within the Chinese market. This includes a comprehensive overview of maintaining compliance with China’s regulatory landscape, a crucial aspect for successful market entry and sustainability.
Date: 17 January, 2024
Time: 14:00 – 15:00 London GMT (22:00 – 23:00 Beijing CST)
Duration: 60 mins
Agenda Highlights
12:00 – 12:05 Introduction & Report Launch
12:05 – 12:20 Overview of Medical Device Regulation and Product Lifecycle in China
Provide an overview of the medical device regulatory landscape in China, including the key regulations and requirements that UK medical device SMEs need to be aware of.
12:20 – 12:35 Strategies to Accelerate Medical Device Premarket Approvals in China
Share best practices for obtaining medical device premarket approval in China, including regulatory strategies, testing requirements, clinical evaluation, registration timeline and cost estimates.
12:35 – 12:50 Ensuring Compliance in Medical Device Postmarket Surveillance in China
Share insights on maintaining post-market compliance with medical device regulations in China , including post-market surveillance, device modifications, and ongoing compliance obligations.
12:50 – 13:00 Q&A Session