Regulations on supervision and administration of medical devices to be amended

Source: on November 10, 2017, the State Food and Drug Administration issued the amendment to the regulations on the supervision and administration of medical devices (Draft for comments) In the draft for comments, 8 articles and 19 articles are added to the current regulations to improve the holder system of medical device listing license; the regulatory requirements are improved after listing; it is planned to change the approval of clinical trials of the third type of high-risk products from explicit to implicit, and increase the provisions on the acceptance of overseas clinical trial data and the expansion and use of clinical trial medical devices; it is planned to not For the innovative medical devices listed on the market, it is no longer required to provide the certification documents of the competent authorities of the country (region) where the medical devices are listed and sold For the product inspection report submitted in the draft for comments when applying for the registration of class II and class III medical devices, the inspection report that should be issued by the medical device inspection institution shall be adjusted to be either the self inspection report of the applicant or the inspection report issued by the qualified medical device inspection institution Make clear the conditional approval of medical devices used to treat rare diseases, serious life-threatening diseases without effective treatment means, and urgent public health emergencies; improve the continuous registration in combination with the problems found in the supervision, and do not continue to monitor adverse events or conduct post Market Research and re evaluation if the safety and effectiveness of products cannot be guaranteed Registration The draft for comments makes it clear that the second category of medical devices that can ensure their safety and effectiveness through routine management in the circulation process are exempt from the requirements of business filing; the supervision of old medical devices is strengthened and the operation of used medical devices is prohibited Add specific provisions on punishment to person, and stipulate that if the medical device registrant, recorder, production and operation enterprise, user intentionally commits illegal acts or has gross negligence, or if the circumstances of the illegal acts are serious, the nature of the illegal acts is bad or causes serious consequences and other serious adverse social effects, the legal representative, the main person in charge, the directly responsible person in charge and other direct responsibilities shall be imposed Any employee shall be imposed with a fine of not less than 30% but not more than 1 time of his previous year's income.