One of China’s largest regulatory bodies, the State Food and Drug Administration (SFDA), has released a set of new rules detailing punishments for a variety of violations. Violations by pharmaceutical and medical device manufacturers will be met with heavy fines and other sanctions starting January 1st, 2013.
According to information released by the SFDA, some violations in the new set of rules will warrant aggressive corrective action. The violations are detailed in the country’s Administrative Punishment Law.
Violations that will face an increased regulatory response include the manufacture and marketing of substandard or counterfeit medical devices that can lead to personal injury. In addition, the manufacture and marketing of these devices by a company with previous violations will be met with a harsher response.
The new law also increases the severity of inspection tampering. Any attempt by a company to stymie SFDA inspection efforts will be met with harsh corrective action.
However, the new set of rules by the SFDA also reduce the penalties for certain violations. For example, a company that takes the initiative to recall or correct a substandard device may face lower fines and other sanctions by the Chinese government. In addition, cases of coercion by a manufacturing partner will face reduced corrective actions. Lighter penalties will also be given for companies that perform well in the eyes of the SFDA.
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