Applying NMAP Medical SW Guidance r2022 to Registration submission and QMS
Join this webinar to learn everything you need to know on China’s latest medical device software registration and QMS management system
On March 9. 2022, Centre for Medical Device Evaluation (CMDE) of National Medical Product Administration (NMPA) in China issued the Registration Guidance on Medical Device Software (2022 revision) (hereinafter referred to as “the Guidance Revision 2022”). It is an important document for China’s management on medical device software. The purpose of the document is to guide applicants on how to prepare the lifecycle management and registration submitting documents for medical device software.
In this webinar, BESTAO invited experienced expert in this field to help global customers and partners better understanding this critical document and the whole relevant compliance system in the medical device software management and supervision.
The main topic of the webinar include:
· Overview of Guidance documents with medical software content
· Changes to premarket submissions resulting from the guidance Revision 2022
· Applying new requirements to Quality management system
Keynote speaker:
Dr. ZHAN li
Over 15 years of experience in NMPA submissions, post-market surveillance compliance, quality management, medical device policy and standardization advocacy. Engaged in several technical guidance drafting working group as SME representative from industry. Take variance leadership positions in GE healthcare and Siemens Healthcare.
Webinar Info:
The webinar will last for about 60 mins
Registration fee: US dollar $598
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