Medical device manufacturing enterprises shall organize production in accordance with the technical requirements of registered or filed products, and ensure that the medical devices that leave the factory meet the mandatory standards and the technical requirements of registered or filed products. The medical devices that leave the factory shall pass the inspection, and a certificate of conformity shall be attached.
According to Article 145 of the Criminal Law, the production and sale of medical devices and medical materials that do not meet the national and industrial standards for protecting human health, if the circumstances are serious and endanger human health, constitutes a crime of medical devices; If not, it does not constitute this crime.