A medical device company asked me to be their nominal quality director. If something goes wrong, what kind of legal responsibility should you bear?

Need to bear certain responsibilities. Since you are the person in charge of quality, you may have to bear corresponding legal responsibilities. If there are quality problems, you may be sued. But whether the quality director should make compensation depends on the responsibilities of the quality director and the agreement in the contract with the medical device company.

Legal analysis

The quality manager needs to supervise the product quality, and the company will usually bear the responsibility of legal compensation, but if it is due to the malice or gross negligence of the quality manager, it will also bear the corresponding responsibility. Civil liability for product quality refers to the legal consequences that producers, operators and persons directly responsible for product quality should bear if they violate the product quality obligations stipulated in the Product Quality Law. If a medical institution or individual knows or should know that the medical devices and medical and health materials specified in the preceding paragraph do not meet the national standards and industry standards for protecting human health and purchase them and use them for compensation, he shall be convicted of selling substandard medical devices and be severely punished according to law. During the period of prevention and treatment of sudden infectious diseases and other disasters, those who produce and sell medical devices or medical and health materials used for prevention and control of infectious diseases that do not meet the national or industrial standards for protecting human health, or who know that they are used for prevention and control of infectious diseases but have no protective or therapeutic functions, which is enough to seriously endanger human health, shall be convicted of producing and selling unqualified medical devices in accordance with the provisions of Article 145 of the Criminal Law.

legal ground

Article 145 of the Criminal Law of People's Republic of China (PRC) shall be sentenced to fixed-term imprisonment of not more than three years or criminal detention, and a fine of not less than 50% but not more than two times the sales amount shall be imposed; Whoever causes serious harm to human health shall be sentenced to fixed-term imprisonment of not less than three years but not more than ten years, and shall be fined not less than 50% but not more than two times the sales amount; If the consequences are especially serious, he shall be sentenced to fixed-term imprisonment of not less than 10 years or life imprisonment, and shall also be fined not less than 50% but not more than 2 times the sales amount or his property shall be confiscated.