Yuling Hu began her career in the medical device industry in 2003, working with China local company GRIKIN. She held several positions, ranging from R&D Engineer to Quality Assurance and Regulatory Affairs (QA/RA) for cardiovascular and non-vascular implant devices. She then moved to Stryker where she focused on RA for orthopaedics implants for China National Medical Products Administration (NMPA) submission. Since joining NAMSA in 2014, Yuling has worked with a number of medical device manufacturers, assisting them with regulatory approval in China for various devices, such as wound care devices.
CORE COMPETENCIES
- Developing regulatory and clinical strategies for China NMPA submission, including regulatory pathways, clinical evaluation pathways and estimation of registration timeline and cost
- Implementing full registration process from initiation to the final approval for China NMPA submission for Class I, Class II and Class III devices
- Developing product technical requirement based on the applicable standards and product specifications for type testing, identifying China labs to perform tests and following up to ensure final reports are received
- Developing submission dossiers based on China regulations, including preparation/input into key documents
- Responding to the NMPA supplementary notice, including meeting with NMPA reviewer and development of the supplementary documents
- Preparing and reviewing of Clinical Evaluation Reports (CERs) based on China regulations
- Gap analyses of overseas clinical trials for China NMPA submissions based on China regulations
- Gap analyses and reviews of Biological Risk Assessments (BRAs) based on China standards and regulations
- Supporting China regulatory affairs for raw material manufacturers of medical devices
RECENT PROJECTS
- Developed regulatory and clinical strategy for several devices for start-up companies and overseas companies
- Successful approval from NMPA with response to NMPA supplementary notice
- Successful submissions to NMPA based on China regulations