Date: Thursday, September 2, 2021, 7:00-8:00 AM Pacific Time (US and Canada)
With the implementation of Order 739 in July 2021, China National Medical Product Administration (NMPA) continues to strengthen the product lifecycle supervision and impose heavier penalties on illegal violations. This live webinar aims to help the audience understand fundamentals of medical device QMS/GMP in China, align with the most recent NMPA regulatory updates, and learn more details about the post-market surveillance requirements in China. You should be able to answer the following questions as a foreign medical device manufacturer, NMPA certificate holder, legal agent, and distributor in China:
- Do you fully understand the post-marketing requirements and responsibilities for your product?
- Do you have enough confidence that you comply with all NMPA post-market requirements?
- Do you know how to handle adverse events, recall, and NMPA inspections?
- Do you know the consequence and penalty for incompliance?
- NMPA medical device regulations/guidelines and major updates
- NMPA medical device QMS/GMP and its alignment with international regulations or standards
- Medical device product lifecycle management with a focus on Design Control
- Responsibilities and potential risks of medical device license holder in PMS
- How to choose distributors who are compliant with NMPA requirements in China?
- Adverse event reporting management under Order 739
- Recall/Field action management under Order 739
- Draft and submit periodic risk evaluate report (PRER) to China NMPA
Guobao Wei, PhD
Sr. Quality Manager, Siemens Healthineers
Dr. Wei has extensive experience in medical device product development, manufacturing process innovation. and organizational quality excellence. He holds more than 40 patents in biological technologies and is an ASQ certified Quality Manager (CMQ/OE), Quality Engineer (CQE) and Quality Auditor (CQA).
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 trainings, and maintaining communication with China NMPA.