Deep Dive into China's Medical Device Regulatory Market: A Comprehensive Guide 

The webinar was successfully concluded on

July 3, 2024

What is it all about?

In a nutshell, during the webinar, our presenter – Summer Xia discussed the following topics:

  • China Medical Device Industry - Background.
  • The Chinese Medical Device Regulatory Landscape.
  • The Factors Affecting Medical Device Registration in China.
  • Different Registration Pathways for Medical Devices in China.
  • Detailed Registration Process for Medical Devices in China.
  • Post-market Regulatory Requirements.
  • Freyr Success Story.

As a continuous practice, Freyr organizes more webinar sessions related to Regulatory aspects in Life Sciences. We presume you would like to be a part of all those sessions. If yes, let us have an opportunity to inform you about our next session.


Sushil is a seasoned strategist with five (05+) years of experience in Medical Device, Healthcare, and FMCG sectors. He holds a BE and MBA from BITSoM and is certified in ISO 13485 audit and Lean Six Sigma Green Belt from TUM Munich. He is proficient in Go-to-Market strategies, key account management, and team building. He excels in assisting clients to enter new markets and offers comprehensive Regulatory solutions, developing customized strategies that enhance organizational value.


With over twenty (20) years of experience, including fifteen (15) years in medical device Regulatory affairs, Summer has excelled in navigating both pre-market and post-market requirements. Her expertise has been instrumental in guiding numerous foreign and local manufacturing companies entering the Chinese market. Summer’s leadership has been demonstrated through her roles heading multinational quality assurance and Regulatory affairs teams. She holds an MBA and is a certified Lead Auditor by BSI, enabling her to proficiently manage complex compliance landscapes.


Sushil Bhatt

Deputy Manager- Europe & Africa, Freyr Solutions


Summer Xia

Associate Director- Medical Devices, Freyr Solutions (China)