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Medical Devices / Regulatory Affairs

China FDA to Require Registration, Training of Medical Reps

Jan. 11, 2018

China FDA released draft regulations that would require medical representatives in China to register, and mandate that medical device marketing authorization holders provide adequate training.

Medical representatives are defined as professionals, rather than sales persons, who perform academic promotion and technical consultancy work, so it is “not surprising that the CFDA requires medical representatives to have certain qualifications and/or related experience,” Katherine Wang, partner at law firm Ropes & Gray in Shanghai, tells FDAnews.

Under current CFDA regulations, medical representatives are not required to be registered. The draft regulation spells out qualification requirements for medical reps, including a two-year junior college degree or higher with a major in life sciences.

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