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

Pharmaceutical Network, June 18,to check wholesalers, sellersJune 15, the State Drug Administration issued a notice on further doing a good job in the investigation of cases related to matters, covering all cities nationwide medical device supervision, will be combined with the new revised laws
and regulations, to combat illegal and illegal activities.the key points of inspection at all levels are different: the State Drug Administration will strengthen guidance and supervision
, promote the implementation of thedrugsupervision rights, and the provincial drug supervision and administration departments should further strengthen the supervision of the investigation and prosecution of cases ofviolations of medical devices in their jurisdictions, in accordance with the principle of combining hierarchical management with territorial jurisdiction.At the same time, combined with local reality, the drug supervision and administration departments at all levels to implement the regulatory object directory system management, the jurisdiction of all the regulatory objects into the hierarchical supervision directory, and effectively achieve supervision without blind areas, no cross- and no omissions.Which subjects will be involved? At what point?.The circular points out that the provincial, municipal and county-level drug supervision and administration departments will further improve the responsibility for the supervision and prosecution of third-party platforms for medical devices wholesale, retail chain headquarters, Internet sales and case investigation, as well as the bridging mechanism, and the responsibility for the investigation and prosecution of illegal and illegal acts .　　Multi-sectoral joint The circular indicated that coordination mechanisms with the market supervision and management authorities would be strengthened Some 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 functions .　　Check whether the operation and production compliance notification requirements, the regulatory authorities at all levels should promptly fix the evidence of suspected violations of the law .　　In the inspection will be fixed evidence, on the routine inspection, system inspection, flight inspection, audit and inspection, sampling inspection, complaint report investigation and other regulatory work found in the suspected illegal and illegal development, production, operation, use of medical devices clues .　　In accordance with the requirements of the Interim Provisions on Administrative Penalty Procedures for Market Supervision and Administration, the evidence shall be collected and fixed at the first time and on the first site and written records shall be produced .　　Where it falls under the jurisdiction of this 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 procedures . the implementation of the "black nest" first office responsible system For 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 it .　　The clues found in a timely manner to carry out on-site verification and disposal, suspected of committing crimes, timely transfer of the case to the public security organs, and do a good job of follow-up cooperation .　　The law enforcement of the joint public security departments shall, as required, strengthen cooperation with the public security organs at all levels .　　In the course of investigating and prosecuting cases of violations of laws and regulations, in accordance with the requirements of the Notice on the Measures for the Administration of Food and Drug Administration and criminal Justice, the public security organs shall be actively communicated and those found to be suspected of violating public security management or suspected crimes shall be promptly transferred to the public security organs, and shall not be punished instead of punishment .　　Where a public security organ solicits 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 specific opinions in a timely manner .　　If the drugs indicated for indications or functional treatment exceed the prescribed scope, expired drugs, drugs that do not indicate or change the validity period or product batch number, and other drugs that have sufficient evidence to prove that they are counterfeit or inferior, they shall not be sent to the drug inspection institution for inspection, and the opinions of the identification shall be issued directly .　　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 responsibility, the drug supervision and administration department shall promptly impose administrative penalties in accordance with the law .　　At the same time, social supervision will be strengthened Give 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 reasons .　　If a very small number of parties fail to comply with the decision on administrative punishment in accordance with the law, but also refuse to sign and collect the notice documents, or 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, they shall be jointly punished in accordance with the law with the public security organs .　　Penalty violations track edifying people
notice that the "punishment to the person" will be strictly enforced .　　Drug supervision and administration departments at all levels should strengthen "punishment to people" and strictly implement the provisions of relevant laws and regulations First, 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 Management Law and other laws and regulations to the unit legal representatives, principal son-in-charge, directly responsible for the person in charge and other relevant personnel to prohibit the production and operation of drugs within a certain period of time to prohibit the administrative punishment .　　Second, strict implementation of 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 .　　For the enterprises that have serious violations of laws and regulations, the and related persons in charge shall be included in the drug credit system, and at the same time, the supervision and punishment will be strengthened, the list shall be summarized and provided to the department responsible for the implementation of joint disciplinary measures, and joint disciplinary measures shall be implemented in accordance with the relevant provisions .　　The local protection notice 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 time include: cases of quality and safety of medical devices that cause death of persons or serious harm to human health; cases in which the circumstances of violations and laws are serious enough to revoke or revoke relevant approval documents; and cases involving the production and sale of counterfeit medical devices worth more than 10 million yuan (including 10 million yuan) .　　The 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 .　　For cases with complex cases, serious harm and bad impact, supervision shall be carried out, and on-site supervision shall be sent to supervise the cases of suspected crimes with greater influence, and the cases of shall be investigated and prosecuted in a case that is inadequate, serious local protection and poor connection to execution, etc., to be informed of 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 .　　The national rectification has been launched
June 3, the State Drug Administration held an outbreak prevention and control medical device supervision and sampling video dispatch meeting, further implement the General Administration of Market Supervision and other seven ministries" national epidemic prevention materials product quality and market order special corrective action plan," the content sits that: 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, all aspects of the price testing and price charges should be traced to dealers, production enterprises and certification inspection and inspection 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 .　　With regard to certification inspection and testing, the circular states that the important role of certification inspection and testing institutions in quality supervision will be given full play, and the list of institutions engaged in domestic certification and certification business in major international jurisdictions will be clarified and published .　　We will crack down on the illegal acts of forging, fraudulently and illegally trading certification certificates and certification marks, and engage in certification, inspection and testing activities in our country without authorization .　　Will be combating the production and sales and export of products that do not meet the relevant standards, doped in the products adulterated, falsely falsely charged, with sub-filling or with unqualified products posing as qualified products, production and sales of expired products, production and sales of no production date, no factory site, 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 a national special rectification action supervision, the end of June to conduct a comprehensive summary of the work .