New Leaders of CFDA, with More Expertise, Emerged

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March 21, 2018
CFDA: 22 Foreign Devices Recalled Last Week
March 27, 2018

New Leaders of CFDA, with More Expertise, Emerged

The cabinet Reshuffle Plan, unveiled by China’s State Council on 13 Mar, established the National Market Supervision Administration (NMSA). CFDA, along with Administration for Industry & Commerce (AIC), and Administration of Quality Supervision, Inspection and Quarantine, is to be integrated as NMSA.

On 21 March, the leadership of NMSA emerged. The following biographical sketches are compiled by China Med Device, LLC, a consulting firm specializing in China CFDA regulatory, CRO and market access services.

The newly-appointed director is Zhang Mao. He was a deputy mayor of Beijing, secretory of Ministry of Health, and then director of Administration for Industry & Commerce. In Beijing Olympic Games Organizing Committee and Beijing Anti-SARS campaign, he played a vital role as a co-leader. He also inked agreement to enhance global intellectual property cooperation when he was in power of AIC.

The first Secretary of NMSA, Bi Jingquan, graduated from the Economics of Peking University in 1982. With twenty-year experience in price control, he co-led China’s entry into the World Trade Organization and compiled the planning outline for China’s logistic industry. Over the past 4 years as chief of CFDA, he initiated several reforms in medical device industry, including innovation approval, marketing-authorization holder program and accepting of overseas clinical data.

According to the Plan, the State Drug Administration, under NMSA, is to be separated from State Food Administration in order to specifically address the regulation of pharmaceuticals, medical devices, IVDs and cosmetics. Bi’s successor Jiao Hong, graduated from Biology of Wuhan University, served as chief pharmacist for Yiyao Pharmaceutical Group for 11 years. Entering CFDA in 2012 as chief safety officer and then deputy director, she was responsible for China’s entry into International Council for Harmonization (ICH), initiation of overseas inspection and heightening quality system for medical device in line with international standard.

The new secretary, Li Li, served as a surgeon at a local hospital for 12 years. After another 10 years of journey as chief of department of health, he took office of Vice Governor of Jiangxi province.

 

About China Med Device, LLC

China Med Device, LLC provides turn-key solutions for western medical device/IVD companies to enter China with regulation and commercialization services. Our CFDA regulatory services cover strategy, premarket submission, clinical evaluation, CRO, post market compliance as well as legal agent representation. Our commercial services cover market assessment research, reimbursement, partnership, distribution qualification and management. We have an office in Beijing, Suzhou and Boston. Our management team have 100+ years of combined experience in medical device and IVD and had been involved with 1,000+ CFDA certificates, 200+ western companies’ entry.