Tony Liu has more than ten years of CFDA regulatory experience from premarket approval to post-market surveillance and quality compliance. He was mentored by a top CFDA review chief. His career spans from R&D engineer to CFDA regulatory manager and supervisor at Beijing JR Technology Company, Philips Healthcare and Brady Regulatory Services Tech. His technical knowledge combined with his seasoned wide range of regulatory practical experience has enabled him to not only successfully obtained many CFDA approvals for the most complex class III medical devices but also to have established GMP approved facilities with clean rooms in China. Tony is leading a team of 20 regulatory professionals in Beijing focusing on CFDA medical device/IVD regulatory services in the following areas: Premarket: registration, clinical evaluation and trial, QMS establishment and audit, CFDA manufacturing license. Post-market: distribution license, adverse event and recall, labelling and manual, CFDA advertisement approval. GMP and regulatory compliance assessment and audit preparation.
Tony received BS from Northern Industrial University with joint degree in Physics and English.