Regulation of Medical Devices in China.

Regulation of Medical Devices in China.
This webinar will outline the regulatory environment for medical devices and give an overview on the pre-market and post-market processes in China.


When:
26 January 2021 | 9:00 GMT



Overview 

Webinars photoThis webinar will offer an overview on the pre-market and post-market processes including: registration submission processes, guidance compliance on medical device registration and clinical trials, product re-calls and overseas inspections. During the webinar you will also be shown an animal-derived product registration case study that was conducted in China.

 

Learning objectives

After attending this webinar participants will:

  • Have an overview on the pre-market process including: official submission organisation summary, regulation/guidance compliance on medical device registration and clinical trial
  • Have an overview on the registration submission process
  • Learn about the post-market process including: UDI, ADR, product re-call, overseas inspection 
  • Receive an update on NMPA regulation
     

Target Audience

Regulatory affairs professionals with 2-5 years' experience who are interested in NMPA registration. 

Speaker

Wendy K
Senior Engineer
Qualtech Consulting Corporation

Wendy is an experienced engineer in pre-market and post-market medical device field for 3 years. 

She has been located in China for two years, where she is conducting clinical trials and supporting on NMPA submission of documentation, which is required to obtain regulatory approval of medical devices in China.
 


 

CPD

This course offers 1 CPD hours for successful completion. To learn why CPD is important visit our Lifelong Learning page.

How do I register?

Simply log in or create an account and then register using the 'Register Myself' button that will appear below once you are logged in. 

Prices

Type Member  Non-member 
Standard    £70 + VAT £95 + VAT 
 

Discounted Places

A limited number of discounted places are available at the rates below for those:

Please email meetings@topra.org for a discount code before making your booking.

Type Member  Non-member 
Discount  £35 + VAT*  £47.50 + VAT* 


* VAT, if applicable, is charged at a rate of 20%.

Terms and conditions

By purchasing this webinar, you are agreeing to the terms and conditions.

 

When
26/01/2021 09:00 - 10:00
Where
Asia Pacific ONLINE
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