Our CEO, Grace Fu Palma, Will be Speaking on 2017 RAPS Regulatory Convergence!

CFDA Updates: Notice on “Requirements of Using Chinese Language for the Name, Resident and Production Address of Applicants, Registration Agents and Filers on Import Medical Devices”.
September 1, 2017
CFDA announced the new “Medical Device Classification Catalogue”!
September 7, 2017

Our CEO, Grace Fu Palma, Will be Speaking on 2017 RAPS Regulatory Convergence!

China Med Device, LLC Founder and CEO, Grace Fu Palma, will be speaking on CFDA approval and updates at the upcoming 2017 RAPS Regulatory Convergence in DC.  Ms Palma, a 20 year medtech veteran, is invited as the leader and moderator for the session “The Art of Getting CFDA Premarket Approval in the Shortest Time Possible” at 1:15PM to 2:45PM Tuesday, Sept 12th. The place of the session is in National Harbor Room 12-13.  RAPS will be held from September 9th to 12th in National Harbor at the DC Waterfront. Qianqian Zhu, her detail on the front cover, and Xiaoyun (Linda) her detail on the cover are part of the panel members.

This year’s RAPS Convergence features more than 70 educational offerings and over 200 expert speakers, including top regulatory officials, expert executive, innovators and thought leaders here to share knowledge, update the latest development, discuss trends and examine regulatory issues in depth from multiple angles.

In this session, Grace and her panel members will cover how CFDA medical device and IVD regulatory changes that affect the registration process and share best practice to expedite the approval time and avoid pitfalls. They will also address clinical evaluation and clinical trial topics. The session will provide attendees with the practical knowledge for CFDA premarket approval related areas:

  • CFDA regulation 2016 and 2017 Updates
  • CFDA Registration Strategy and Key factors for medical devices and IVD
  • Best practice to shorten approval time for medical devices and IVD
  • Chinese standards GB/YY
  • EU CER and China CER comparison
  • Common pitfalls to avoid in Medical Devices and IVD registration

There have been hundreds of standards and guidelines updated in the past few years initiated by the “China State Council decree of No. 650 Regulation on Supervisory Management of Medical Device” in 2014. The changes and updates are continuing today Due to culture and regulation differences, what works wtih FDA in the U.S. may not work with CFDA in China.

China Med Device, LLC team sincerely invite you to come and Join us.

For more information about, or to register for 2017 RAPS Regulatory Convergence, please visit RAPS Regulatory Convergence or email RAPS at raps@raps.org.

 


About China Med Device, LLC (CMD) CMD provides turn-key solution for Western medtech companies with regulatory and commercialization services. CMD helps its clients accelerate China entry and growth by offering: market Intelligence and research; CFDA regulatory services (premarket submission, clinical evaluation, clinical trial design & management, post market compliance and legal representation), and other commercial services. If you have an inquiry or feedback regarding our services please email us at info@ChinaMedDevice.com.