Medical device rectification begins, unqualified products will be traced back
Last Update: 2020-06-17
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June 8th, non-conforming products will be traced back to the wholesampling of equipment products qualified
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", and release important information, specifically:meeting stressed that thedrugregulatory authorities at all levels to use supervision and inspection means to test the problem of enterprisesIn accordance with the requirements of the State Bureau, we should promote the supervision and sampling ofmedical devices, and strengthen the spot checks and tests of new coronavirus detection reagents, ventilators, medical protective clothing, medical masks, ethluded guns and other epidemic prevention and control medical devicesIt was pointed out that the sampling of high-risk products should be highlighted, and the supervision and sampling of newly approvedenterprises, newly registered products, and products found in risk signals in daily supervision should be strengthened to ensure that relevant enterprisesproduct qualityRecently, the General Administration of Market Supervision, the National Development and Reform Commission, the Ministry of Industry and Information Technology, the Ministry of Public Security, the Ministry of Commerce, the General Administration of Customs, the Drug Administration jointly issued the "National Epidemic Prevention Materials Product Quality and Market Order Special Rectification Action Plan" notice, requiring relevant departments throughout the country to carry out corrective actionThe whole process of rectification will run through the whole chain supervision of the production, circulation, consumption and export of epidemic prevention materialsWill check the source of production, enterprise qualifications, product standards
, product quality At the same time, the whole process of non-conforming products will be traced back to the law to investigate the responsibility of production operators, strict inspection of the quality of export epidemic prevention materials The list of national medical device inspectors was announced
june 3, the State Administration Food and Drug Audit and Inspection Center issued the fifth batch of "National Medical Device Inspector List", so far five batches of equipment inspectors a total of 230 people All over the response, the establishment of professional inspection team On May 21, The Guangdong Drug Administration announced that some inspectors were qualified, according to Thesaie Blue Equipment Observation, many provinces have set up professional medical device inspection teams, Jiangxi, Shaanxi, Hebei, Shandong, Zhejiang, Shanghai and so on This means that in the medical device inspection, the most professional inspectors to come, the State Council previously issued "on the establishment of professional professional drug inspectors." The document emphasizes that professional izedmedical device inspectors refer to those who, as determined by the drug regulatory authority, conduct compliance confirmation and risk research on the places and activities of the management of the opposite person engaged in drug development and production in accordance with the law Specifically, the State Council regulatory department's main medical device research and development process on-site inspection, will be from the medical device clinical trial quality management specification senforcement compliance inspection To undertake the overseas on-site inspection of medical devices and the production of major causes of inspection On-site inspection of the production process of the main medical devices by the provincial drug regulatory department, as well as the compliance inspection of the implementation of the production quality management practices The provincial departments will also conduct on-site inspections of medical device wholesale enterprises, retail chain headquarters and internet sales third-party platforms It can be seen that the country for the medical device field of all links, all channels have been deployed The of medical device dealers in the "National Epidemic Prevention Materials Product Quality and Market Order Special Action Plan" notice, will comprehensively strengthen the export of epidemic prevention materials supervision 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
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