Medical Software Compliance in China

- NMPA 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 $298

(Invoice can be applied after finishing the payment on our website)

For the convenience of our global clients and partners, we arranged two identical sessions that fit different time zones. You may choose the most suitable for you.

Webinar 1: for European audience

Wednesday, June 15, 2022, 10:00 am Europe (Brussels, GMT+02:00)

Webinar 2: for American audience

Wednesday, June 15, 2022, 2:00 pm Pacific Daylight Time 

(San Francisco, GMT-07:00; 4:00 pm Central Daylight Time, 5:00 pm Eastern Daylight Time)

Webinar Registration guide:

1. Click the “Unlock the event detail now” button below to register as a website member then make payment.

2. Once the payment is completed, you’ll be able to see the registration link on this page below. (Invoice can be applied after finishing the payment on our website)  

3. Your registration will be submitted for approval, and once the administrator confirmed the payment and approved your application, you will receive a confirmation email containing full access for webinar.

4. We currently support online payment by credit card and Paypal

5. Webinar registration fee only can be refund by a written application in at least 24 hours before the webinar starts through email to assistant@bestao-consulting.com

Please pay here or contact us for the payment and registration

Any question or issue you may encounter in the process mentioned above, please contact us at: assistant@bestao-consulting.com