MedTech Summit 2022 Recap
The Medtech Summit 2022 was held in person and online from 20th to 24th June, in Dublin, Ireland. Over 300 experts and companies from the medical device industry and regulatory compliance profession attended the Summit which aimed to provide networking opportunities for industry professionals and regulatory experts to share valuable information.
The Summit also invited inspectors and notified bodies for IVD which gave practical suggestions to companies who are currently or will go through the notification procedure.
On 23rd June, Amy Chen, the Global Market Access Regulatory Compliance Consultant from C&R, presented on Medical Device Post-market Surveillance Regulations in China, Japan, and South Korea.
The presentation gave a high-level overview of Chinese regulations on post-market surveillance and the main changes in the new medical device framework regulation, Order No. 739, in relation to post-market surveillance of medical devices.
It then gave a list of regulations on post-market surveillance of medical devices in Japan and South Korea, together with a comparison table.
In addition, Amy provided some practical tips in terms of the applicability of Chinese standards and communication with authorities.
Attendees also provided some interesting feedback and a quick discussion of the trend in legislation in the jurisdictions discussed.
You can watch Amy’s full presentation here:
Stay Updated On Medical Device Regulations
For more information, check out our recent whitepaper on Medical Device Cybersecurity in the USA, or watch our on-demand webinar to learn more about Regulatory Developments in China for Medical Devices
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