Nov 14, 2012

The State Food and Drug Administration (SFDA) of China has set new rules (translated via Google) effective January 1, 2013 that would mete out more severe punishment to medical device and pharmaceutical manufacturers for certain violations.

The SFDA notice lists several violations that warrant more aggressive enforcement of China’s Administrative Punishment Law applied to drugs and medical equipment, while at the same time granting local and regional officials more discretion in determining penalties for violators.

Violations warranting more severe penalties include production and sale of counterfeit or substandard medical devices that cause injury; production of counterfeit or substandard devices by companies found previously to have committed similar violations; and avoiding SFDA supervision or inspection or tampering with evidence that would incriminate the company in question.

On the other hand, the SFDA notice suggests lighter penalties in instances where a violator makes the initial effort to correct improper actions and mitigate public health risks caused by its product, or in cases where the violator has been coerced by another entity to commit an offense. Third, violators can incur lighter penalties if they perform “meritoriously” with the SFDA.

This announcement seems of a piece with recent SFDA notices regarding surprise inspections of medical device manufacturing facilities in China, also set to come into force in 2013. Questions will likely arise, however, as to how aggressively and consistently these rules will be enforced across local and regional authorities. Emergo Group will provide further details on the SFDA announcement as we learn them.


  • Stewart Eisenhart