[Webinar] Expediting The Registration Of Respiratory Equipment And Patient Monitoring Devices In China: Insights, Challenges, And Solutions

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Topic: Expediting the Registration of Respiratory Equipment and Patient Monitoring Devices in China: Insights, Challenges, and Solutions

Date: Friday, August 20, 2021, 7:00-8:00 AM Pacific Time (US and Canada)

In the context of COVID-19, the demand for respiratory equipment (such as ventilators) and patient monitoring devices have skyrocketed almost everywhere worldwide. In China, the respiratory device market is expected to achieve a 20%-30% annual growth in the next 10 years based on market size of 12 billion Chinese Yuan in 2019. In contrast to being regulated as class II devices in the US and EU, these devices may be classified as class III, the most stringent and challenging registration route, in China. Equipped with strong technical/regulatory/clinical expertise in successfully registering numerous ventilators and patient monitoring devices in China, IMD has organized this webinar to help you gain a more in-depth understanding of the registration process of respiratory equipment (including lung ventilators, life-support ventilators, ventilatory support devices, sleep apnea devices, etc.) and patient monitoring devices in China. We will present the optimal regulatory and clinical pathways to expedite the registration of your products in China and share critical lessons to avoid pitfalls and clear roadblocks. Moreover, we would also like to share our insights on how the new Regulation on the Supervision and Administration of Medical Devices (Order 739 issued by the State Council) impacts their registration processes in China.

Join our live webinar to learn about the following facts about respiratory equipment and patient monitoring devices:

Clinical:

• Feasible clinical pathways
• CER updates under Order 739

Non-Clinical:

• Type testing challenges
• Third-party testing labs

Regulatory intelligence:

• Accessory compliances
• Digital health localization
• Impact of UDI to registration

Speaker:

Mike Zhu, PhD

Vice President of Medical/Clinical Affairs, Inspirative Medical

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

Yselin Bai

Senior Project Manager, Inspirative Medical

Yselin has over 10 years of experience in project management and medical device registrations. She has hands-on experience and a deep understanding of digital health, respiratory equipment, and patient monitoring device localization in the China market. 

Registration Link