It's there! The State Drug Administration issued a letter to fix these medical agents.

On June 15,, the State Drug Administration issued a notice on matters related to further doing a good job in the investigation and prosecution of cases, covering the supervision of medical devices in all cities across the country, and will combat illegal and illegal activities in conjunction with the revised laws and regulations of the new systemthe key points of inspection at all levels are different: the State Drug Administration will strengthen guidance and supervision, and promote the implementation of the right to drug supervision;at the same time, combined with local reality, the drug supervision and administration departments at all levels to implement the regulatory object catalog system management, the jurisdiction of all regulatory objects into the hierarchical supervision directory, and effectively achieve supervision without blind areas, no cross, no omissionsWhich subjects willinvolve? At what point?notice that the provincial, municipal and county-level drug supervision and administration departments will further improve the medical device wholesale, retail chain headquarters, Internet sales of third-party platform supervision and case investigation and prosecution of the division of duties and bridging mechanism, compaction of illegal violations of the responsibilitymulti-sectoral jointThe circular indicated that coordination mechanisms with the market supervision and management authorities would be strengthenedSome provincial market supervision and management departments of comprehensive law enforcement departments to assume the functions of medical device violations and violations of the investigation and prosecution functionsThe notice requires that regulators at all levels should promptly fix evidence of suspected violationswill fix the evidence at the time of inspection, and lead the cases of suspected illegal and illegal development, production, operation and use of medical devices found in the supervision work of routine inspection, system inspection, flight inspection, audit and inspection, sampling inspection, complaint report investigation, etcshall, in accordance with the requirements of the Interim Provisions on the Administrative Penalty Procedure for Market Supervision and Administration, collect and fix evidence at the first time and on the first site and produce transcriptsWhere thebelongs under the jurisdiction of the organ, it shall file a case for investigation and prosecution; if the case shall be under the jurisdiction of a higher authority or other organ, it shall be reported or transferred in a timely manner in accordance with the proceduresthe implementation of the "black nest" first to do the responsible systemFor the production of medical devices without obtaining approval documents, the import of medical devices, and the illegal production and operation of medical devices without permission (record), the first-run responsibility system shall be carried out, and who discovers and who handles itto the clues found in a timely manner to carry out on-site verification and disposal, suspected of committing a crime, timely transfer of the case to the public security organs, and do a good job of follow-up cooperationAccording to the requirements, departments at all levels should strengthen cooperation with public security organsIn the process of investigating and prosecuting cases of violations of laws and regulations, theshall, in accordance with the requirements of the Notice on the Measures for the Administration of Food and Drug Administration and the Convergence of Criminal Justice, take the initiative to communicate with the public security organs and promptly transfer them to the public security organs if they are found to be suspected of violating public security management or are suspected of committing crimes, and shall not be punished instead, if the public security organ invites the drug supervision and administration department to provide inspection and identification opinions in handling cases of crimes against drug safety, it shall actively organize research, coordinate the relevant institutions and put forward concrete opinions in a timely manner, if the marked indications or functional treatment exceeds the prescribed scope of drugs, expired drugs, drugs that do not indicate or change the validity period, product batch number, and other drugs with sufficient evidence to prove that they are counterfeit or inferior drugs, without sending them to the drug inspection institution for inspection, they may directly issue a determination opinionthe drug supervision and administration department shall promptly impose administrative penalties in accordance with the law if the judicial organ considers that it does not constitute a crime, is exempted from criminal punishment, and that the judicial organ still needs to be investigated for administrative responsibility after it is investigated for criminal responsibilitywill also strengthen social supervisionGive full play to the role of new media propaganda such as websites, official microblogs and official public numbers, and make public exposure to parties who refuse to implement administrative penalty decisions without justifiable reasonsto the very few parties who do not perform the decision on administrative punishment in accordance with the law, but also refuse to sign and collect the notice documents, and even violent resistance to the law, inciting others to jointly resist the law and other obstacles to law enforcement officials to carry out their official duties in accordance with the law, shall be jointly punished in accordance with the law with the public security organsThe circular stated that the "punishment to the person" provision would be strictly enforceddrug supervision and administration departments at all levels should strengthen "punishment to people" and strictly implement the provisions of relevant laws and regulationsFirst, to punish people according to law,to punish illegal units in accordance with the law, in accordance with the Drug Administration Law and the Vaccine Administration Law and other laws and regulations to the unit's legal representatives, principal son-in-charge, directly responsible for the competent personnel and other relevant personnel to prohibit the production and operation of drugs within a certain period of time to prohibit the administrative punishmentThe secondis to strictly implement administrative responsibilities In the decision on administrative punishment, the contents of punishment, such as the qualification penalty of personnel, should be clarified, and the public and accept social supervision Third, the implementation of joint disciplinary measures incorporating the situation of enterprises and related persons in charge of serious violations of laws and regulations into the drug credit system, and at the same time increasing supervision and punishment, the list will be summarized and provided to the department responsible for the implementation of joint disciplinary measures, and joint disciplinary measures shall be carried out in accordance with the relevant provisions The circular requires the provincial drug supervision and administration departments to report major cases in a timely manner The major cases that should be reported in writing to the State Bureau in a timely manner include: cases of medical device quality and safety that cause death of persons or serious harm to human health; cases of serious violations of laws and regulations, enough to revoke or revoke relevant approval documents; and cases in which the value of the value of the production and sale of fake medical devices is more than 10 million yuan (including 10 million yuan) State Bureau should strengthen the prevention and control of case risk, focusing on the progress of case handling, risk prevention and control, information dissemination and the major problems encountered in the investigation and prosecution of cases to the case of complex, serious harm, bad impact of the case, to carry out supervision, according to the case sent to the scene supervision, the impact of the case, to cooperate with the public security organs to carry out supervision and supervision, the case investigation and prosecution is weak, local protection is serious, the execution of the case is not good, etc , to inform criticism Third, the provincial drug supervision and administration departments should strengthen the risk prevention and control of major cases The major cases that need to be reported by the municipal and county-level drug supervision and administration departments shall be reported in a timely manner in accordance with the relevant provisions, and the provincial drug supervision and administration departments shall promptly study and determine the risks and supervise them On June 3, the State Drug Administration held a video dispatch meeting on the supervision and sampling of medical devices for epidemic prevention and control, and further implemented the "National Epidemic Prevention Materials Product Quality and Market Order Special Action Plan" of seven ministries, including the General Administration of Market Supervision, which states that the will comprehensively strengthen the supervision of export epidemic prevention materials We will strictly control the quality of exports of five types of epidemic prevention materials and increase the inspection of export epidemic prevention materials for export products that do not meet the relevant quality standards, to trace dealers, production enterprises and certification inspection, price charges in all aspects To report more complaints to the export enterprises to carry out a comprehensive verification, sampling is not qualified, there are major problems of product quality and safety, according to law strictly investigated for certification inspection and testing, the notice states that the important role of certification inspection and testing institutions in quality supervision will be given full play, and that the list of institutions engaged in domestic certification and certification business in major international jurisdictions will be clarified and published crack down on counterfeiting, fraudulent use, illegal trade in certification certificates and certification marks, without approval in China to engage in certification, inspection and testing activities illegal acts will crack down on the production and sales and export of products that do not meet the relevant standards, doped in the product, falsely falsely, with sub-filled or with unqualified products posing as qualified products, production and sales of expired products, production and sales of no production date, no factory location, no product quality certificate and other "three no" products and other quality violations time, the notice pointed out that in mid-to-late May, the General Administration of Market Supervision and the relevant departments to carry out the supervision of the national special rectification action, the end of June to conduct a comprehensive summary of the work.