Ms. Zhang Sufang is familiar with Chinese medical device registration regulations and has 12
years of rich registration experience in IVD product registration. Since 2010, Ms. Zhang has
been engaged in the registration and declaration of medical devices, and has worked for
companies such as Fujirebio, Abbott, Wuxi AppTec, Illumina, and BGI. The products involved
include biochemical, immune, blood cell, second-generation sequencing instruments and reagents,
PCR products, etc., covering Class I, II, and III products, as well as active devices. She has
participated in the formulation and verification of industry standards for testing agencies,
including industry standards for prolactin, FSH, T3, rubella virus IgG/IgM test kits,
high-throughput sequencers, etc.
Ms. Zhang started her career in medical device registration filing in 2010, and has worked for
Fujirebio Corporation, Abbott, WuXi AppTec, Illimina and UW. The products involved are
instruments and reagents for biochemistry, immunology, blood cell, and second-generation
sequencing, PCR products, etc., covering Class I, II, and III products, as well as active
devices. Participated in the development and validation of industry standards for testing
organizations, and has participated in industry standards including: kits for lactogen, FSH, T3,
rubella virus IgG/IgM, high-throughput sequencers, etc.
Bachelor of Medicine from Sun Yat-sen University School of Public Health; Master's
degree in Business Administration from China Agricultural University.