RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

China NMPA Regulations and Processes for Medical Devices

12.0
RAC Credits
Wednesday, 17 June 2020 (9:00 AM) - Thursday, 18 June 2020 (5:00 PM) Eastern Time (US & Canada)

In order to provide you a level of certainty in planning in the face of the COVID-19 situation, this event is now being delivered online as an online workshop. We are working with our instructors to ensure that the same learning objectives and quality of the education will be delivered regardless of this modification. RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

China has become the second-largest economy in the world and one of the most important markets for international businesses. As a regulatory professional, it is imperative to have a sufficient understanding of China’s NMPA regulations, processes, and expertise to navigate the NMPA system.

 
This workshop is structured to provide attendees with the fundamental knowledge about the NMPA regulations, its processes, and requirements. Led by instructors who are veteran regulatory managers, this course will also include not only their personal experiences but also up-to-date information and current practices. Where applicable, the instructors will illustrate the similarities and differences between the Chinese requirements and US/EU requirements. This course will be a combination of lectures, case studies, and in-class discussions.

 
Registration Closes
:  16 June 2020
Refund Deadline:  18 May 2020
 
RAC Credits:  12 (Upon attending and completing the program)
 
Will the meeting be recorded?  Yes
 
Registration to 18 May 2020
RAPS Members: $800 
Nonmembers: $900
 
Registration from 19 May to 16 June 2020
RAPS Members: $900 
Nonmembers:  $1000
 
NOTE: Advance registration is required for this workshop therefore participants are encouraged to register early. Onsite registrations are not accepted. 
 
Program Schedule 
Wednesday, 17 June (9:00am–5:00pm) 
 
Topics will include (but not limited to): 
 
·         NMPA regulations for medical device
·         Classification and clinical-exempt products
·         Submission process and requirements

Thursday, 18 June (9:00am-5:00pm) 
 
·         Clinical trial and clinical evaluation
·         Quality systems and audits by NMPA
·         Hot topics: “fast track” approval, Post-market, consultation with NMPA and other subjects


NOTE: The agenda may vary based on changing requirements.
 
Faculty
Chang-Hong Whitney, president, Whitney Consulting Ltd.
Patrick Lee (invited)
Vic Zhang (invited)
Lina Zhu (invited)
 
Cancellation or Substitutions 
RAPS reserves the right to cancel this program at its sole discretion. 

All cancellation requests must be submitted in writing to raps@raps.org. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and event title.
 
Due to uncertainty surrounding the COVID-19 situation’s impact on travel our standard cancellation fees will be waived.  Should you need to cancel your registration, you can apply your credit to any RAPS program for the next 12 months.
 
Substitutions may be accepted with written approval from RAPS and must be submitted to raps@raps.org.  Due to uncertainty surrounding the COVID-19 situation, RAPS will allow substitutions up to the first day of the event. 

 
Proof of Attendance
RAPS will send an electronic letter or a certificate of attendance upon request.
 
Questions
Call RAPS Solutions Center at +1 301.770.2920, Ext 200
 
Other Information
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.
 
Registration Form 
If it is your preference, please use the Registration Form to register by mail, email or fax. To expedite your registration for mail orders, your employer must include a copy of the completed registration form. A RAPS online account will be created to complete your purchase if you are not a member or past customer.
 
Program Contact
Nichelle Sankey
nsankey@raps.org
+1 301 770 2920, Ext 291
 

Register