Date: Thursday, Nov 18, 2021, 8:00-9:00 AM Pacific Time (US)
2021 is a big year for medical devices in China. Issued by the State Council, Order 739 (“Regulations on the Supervision and Administration of Medical Devices”) was officially effective in June 2021, which has brought significant changes to medical device registration, testing, clinical evaluation, and post-marketing surveillance. By November 2021, NMPA has issued several finalized regulatory documents such as eight Guidelines for medical device clinical evaluation, Provision for in-house type testing, updated registration dossier requirements, etc.
By the end of 2021, it is time for us to revisit the regulation updates and assess the impact of such changes on foreign manufacturers who wants to bring their products to the Chinese market in a practical and least-burdensome approach.
Agenda:
- Overview of Order 739 vs. 680
- Significant changes in dossier preparation for imported Class II & III medical devices
- Modification registration under Order 739
- Renewal registration under Ordre 739
- How to submit a self-test report for type testing? How to entrust a third-party testing lab? What are the qualifications and limitations?
- Stricter Post-Market Surveillance requirements and MAH’s responsibilities under Order 739
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.
Zhe Ji
QA Manager, Inspirative Medical
Zhe has over 15 years of experience in medical device quality assurance as a team leader for product lifecycle supervision in China. She has extensive hands-on experience in handling post-market recalls, adverse events, and inspections, submitting periodic reports, providing training, and maintaining communication with China NMPA.
Tracy Yu
Senior Project Manager, Inspirative 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.
Registration Link:
https://zoom.us/webinar/register/WN_q7DBXq8zTTGppf7vyyWoXQ
![[Webinar] UK-China Medical Device Access to China](https://imdmedia.s3.amazonaws.com/2021/09/logobgh2.png "[Webinar] UK-China Medical Device Access to China")
