Lei Yang has over 20 years of experience in the medical device industry, with a strong knowledge of regulatory affairs and quality in China. He joined NAMSA in 2016, focusing on China’s National Medical Products Administration (NMPA) regulatory consulting, including biological safety evaluation, registration, post-market support and quality. Prior to working at NAMSA, Lei worked at Medtronic China as the Supervisor of Regulatory Affairs and was responsible for the early technology business unit. He led the regulatory affairs (RA) team to approach various new tech products on premarket access and post-market supervision, such as capsule endoscopes system, electromagnetic navigation bronchoscopy and microwave ablation systems, etc. He also worked for Stryker Neurovascular where he was in charge of both RA and quality assurance (QA) in China. Additionally, Lei worked for Beckman Coulter, where he focused on In Vitro Diagnostics (IVDs) and led his team to handle more than 300 China Food and Drug Administration (CFDA) submissions per year. Lei got his Bachelor of Science degree in Biochemistry from Beijing Normal University.

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 various medical devices for different stage business
• Leveraged internal and external resources from NAMSA and Sponsors to deliver high quality regulation outcome
• Successful approval from NMPA with response to NMPA supplementary notice
• Successful submissions to NMPA based on China regulations