Dr. Jiechen Yin has over 10 years of experience in the medical device industry, with a solid background in scientific research and development. She began her career working with medical device manufactures as a Scientific Researcher. She then began to focus on the clinical evaluation of medical devices after the announcement of the very first version of Technical Guidelines on Clinical Evaluation of Medical Devices and related regulations in China. Jiechen joined NAMSA in 2016 and leads NAMSA’s China Medical Writing team, focusing on clinical strategies and Clinical Evaluation Reports (CERs) in the fields of cardiovascular, radiology, robotic surgery, hearing aid, orthopedic, wound healing, etc. She and her team have successfully worked on over 100 cases, covering a broad range of medical device technologies and organizations.
- Developing strategies for medical device clinical evaluation and registration, including determining evaluation pathways, selecting equivalent devices, feasibility analyses, attending meetings with China National Medical Products Administration (NMPA) Reviewers
- Providing internal and external trainings and developing Standard Operating Procedures (SOPs) following NMPA requirements
- Preparing and reviewing Clinical Evaluation Reports (CERs) in accordance to NMPA regulations and guidelines
- Performing analyses of overseas clinical trial data to support China submissions
- Developing EU CERs following MEDDEV 2.7/1 Rev 4 and Medical Device Regulation (MDR) requirements
- Preparing essential clinical documentations, such as clinical trial protocols, clinical study reports, CERs, etc.
- Composing scientific research articles
- Gap analysis and development of CERs to meet the new requirements of NMPA’s recently announced guidelines and regulations
- Analysis of overseas clinical trial data to support Class III medical device registration in China
- Development of clinical strategy for an early stage device business through Innovation Submission pathway—project included communication with NMPA Reviewers