The State Food and Drug Administration convened a special video and telephone conference to comprehensively strengthen the export quality supervision of medical devices for epidemic prevention and control

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Time of issue:2020-05-13
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(Summary description)OnApril3,theStateFoodandDrugAdministrationconvenedaspecialvideoandtelephoneconferencetostrengthenthequalitycontroloftheexportofmedicaldevicesforepidemicpreventionandcontrol,andre-emphasized,re-deployed,andimplementedthequalitycontroloftheexportofmedicaldevicesforepidemicpreventionandcontrol.Themeetingemphasizedthatthewholesystemshouldfurtherimprovethepoliticalposition,comprehensivelyimplementthespiritoftheimportantspeechofGeneralSecretaryJinpingandthedecision-makinganddeploymentofthePartyCentralCommitteeandtheStateCouncil,inaccordancewiththerequirementsoftheMinistryofCommerce,theGeneralAdministrationofCustoms,andtheStateFoodandDrugAdministrationfortheorderlydevelopmentofmedicalsupplies,Comprehensivelystrengthenthequalitycontroloftheexportofmedicaldevicesforepidemicpreventionandcontrol,andeffectivelyguaranteethequalityandsafetyofexportedmedicaldevices.XuJinghe,deputydirectoroftheStateFoodandDrugAdministration,attendedanddeliveredaspeech. XuJinghepointedoutthatatpresent,theinternationalepidemicsituationisshowingthetrendofacceleratingthespreadandspread,andthenumberofmedicaldevicesrequiredforglobalpreventionandcontroloftheepidemichasincreaseddramatically.Onthebasisoffullysatisfyingtheneedsofdomesticepidemicpreventionandcontrolproducts,China'sepidemicpreventionandcontrolmedicaldeviceproductshavegoneabroadtohelpinternationalepidemicpreventionandcontrol.Ensuringthequalityofmedicaldeviceproductsforepidemicpreventionandcontrolisamatterofnationalimageandinternationalreputation.Thewholesystemmustdeeplyunderstandthegreatsignificanceofthecentralgovernmenttoensurethequalityofmedicalequipmentproductsforexportepidemicpreventionandcontrol,correctlyhandletherelationshipbetweennationalinterestsandcorporateinterests,therelationshipbetweenlocalinterestsandoverallinterests,therelationshipbetweenimmediateinterestsandlong-terminterests,anddoallitcantoexportProductqualitysupervisionworkeffectivelyguaranteesthequalityandsafetyofexportedmedicaldeviceproducts.Themeetingclearlyrequired:First,wemustquicklyfindoutthesituationoftheenterpriseandensurethatthefocusofsupervisionisfocused.Provincialdrugregulatorydepartmentsshouldestablishalistofexportingmedicaldevicecompanies,implementdynamicadjustments,andexportmedicaldeviceproductstomedicaldevicemanufacturersandoperatingcompanies,beawareofthem;superviseandguideexportcompaniestoimproveexportproductfiles,andeffectivelyensuretheproductexportprocessTraceability;promptlynotifythegovernmentofthelocalityoftheexportingenterpriseofthelistofexportingenterprises.Thesecondistodeterminethepersonresponsibleforreportingtoensurethequalityofinformationdisclosure.TheStateAdministrationhascontinuouslyregistered5typesofproductsapprovedbythedrugregulatoryauthority(newcrownvirusdetectionreagents,medicalprotectiveclothing,medicalmasks,ventilators,infraredthermometers)onthewebsiteoftheStateFoodandDrugAdministration;eachprovincialdrugregulatoryauthorityshalldesignateSpecialpersonisresponsibleforinformationreporting.Thethirdistoaccuratelygraspthelegalpositioningandstandardizetheexportsalescertification.EnterprisesthathavenotobtainedamedicaldeviceregistrationcertificateandproductionlicenseinChina,orhavenotfiledmedicaldeviceproductrecordsandproductionrecords,willnotbeissuedexportsalescertificates.Thefourthistoorganizethesystemtobecapableandtoincreasesupervisionandinspection.Provincialdrugregulatorydepartmentsshouldquicklymobilizetheresourcesofthewholeprovince,establishalistsystemformedicaldeviceproductionandoperationenterprisesandaresponsibilitysystemforsupervisors,focusonkeylinks,focusonkeyissues,strengthencontrolmeasures,andallevidenceindicatesthequalityofexportedproductsIfthereisaproblem,itisnecessarytoimmediatelystopproduction,rectify,andinvestigatetheproblem.Iftheproblemsarenotverifiedandtheresponsibilitiesarenotclearlydefined,theproductionandoperationshallnotberesumed.Fifth,highlightthesupervisionofexportproductsandstrengthensupervisionandrandominspection.Provincialdrugregulatorydepartmentsshouldappropriatelyadjustthesamplinginspectionitemsaccordingtotheneedsofepidemicpreventionandcontrolandtheneedtoensurethequalityofexportedproducts.Samplinginspectionshouldcoverallkindsofproductsproducedbyenterprisesinthisprovince,especiallythoseproductsnewlyapprovedbyenterprisesduringtheepidemicpreventionandcontrolperiod.Themeetingalsorequiredthatdrugregulatoryauthoritiesatalllevelsshouldstrictlyfollowtherequirementsofmedicaldevicereviewandapprovalunderthepremiseofensuringproductsafety,effectivenessandqualitycontrol,andstrictlyfollowthesysteminspection,registrationinspection,clinicaltrials,andtechnology.Intheprocessofreviewandadministrativeexaminationandapproval,thereviewandapprovalofequipmentforepidemicpreventionandcontrolshouldbedoneinanorderlymannertoensureproductsafety,effectivenessandcontrollablequality.Inresponsetoviolationsdiscoveredduringsupervision,themeetingemphasizedtheneedtoimplementthe"fourmoststringent"requirements,strictlyimplementcorporateresponsibilityandterritorialmanagementresponsibilities,andinvestigateandde

The State Food and Drug Administration convened a special video and telephone conference to comprehensively strengthen the export quality supervision of medical devices for epidemic prevention and control

(Summary description)OnApril3,theStateFoodandDrugAdministrationconvenedaspecialvideoandtelephoneconferencetostrengthenthequalitycontroloftheexportofmedicaldevicesforepidemicpreventionandcontrol,andre-emphasized,re-deployed,andimplementedthequalitycontroloftheexportofmedicaldevicesforepidemicpreventionandcontrol.Themeetingemphasizedthatthewholesystemshouldfurtherimprovethepoliticalposition,comprehensivelyimplementthespiritoftheimportantspeechofGeneralSecretaryJinpingandthedecision-makinganddeploymentofthePartyCentralCommitteeandtheStateCouncil,inaccordancewiththerequirementsoftheMinistryofCommerce,theGeneralAdministrationofCustoms,andtheStateFoodandDrugAdministrationfortheorderlydevelopmentofmedicalsupplies,Comprehensivelystrengthenthequalitycontroloftheexportofmedicaldevicesforepidemicpreventionandcontrol,andeffectivelyguaranteethequalityandsafetyofexportedmedicaldevices.XuJinghe,deputydirectoroftheStateFoodandDrugAdministration,attendedanddeliveredaspeech. XuJinghepointedoutthatatpresent,theinternationalepidemicsituationisshowingthetrendofacceleratingthespreadandspread,andthenumberofmedicaldevicesrequiredforglobalpreventionandcontroloftheepidemichasincreaseddramatically.Onthebasisoffullysatisfyingtheneedsofdomesticepidemicpreventionandcontrolproducts,China'sepidemicpreventionandcontrolmedicaldeviceproductshavegoneabroadtohelpinternationalepidemicpreventionandcontrol.Ensuringthequalityofmedicaldeviceproductsforepidemicpreventionandcontrolisamatterofnationalimageandinternationalreputation.Thewholesystemmustdeeplyunderstandthegreatsignificanceofthecentralgovernmenttoensurethequalityofmedicalequipmentproductsforexportepidemicpreventionandcontrol,correctlyhandletherelationshipbetweennationalinterestsandcorporateinterests,therelationshipbetweenlocalinterestsandoverallinterests,therelationshipbetweenimmediateinterestsandlong-terminterests,anddoallitcantoexportProductqualitysupervisionworkeffectivelyguaranteesthequalityandsafetyofexportedmedicaldeviceproducts.Themeetingclearlyrequired:First,wemustquicklyfindoutthesituationoftheenterpriseandensurethatthefocusofsupervisionisfocused.Provincialdrugregulatorydepartmentsshouldestablishalistofexportingmedicaldevicecompanies,implementdynamicadjustments,andexportmedicaldeviceproductstomedicaldevicemanufacturersandoperatingcompanies,beawareofthem;superviseandguideexportcompaniestoimproveexportproductfiles,andeffectivelyensuretheproductexportprocessTraceability;promptlynotifythegovernmentofthelocalityoftheexportingenterpriseofthelistofexportingenterprises.Thesecondistodeterminethepersonresponsibleforreportingtoensurethequalityofinformationdisclosure.TheStateAdministrationhascontinuouslyregistered5typesofproductsapprovedbythedrugregulatoryauthority(newcrownvirusdetectionreagents,medicalprotectiveclothing,medicalmasks,ventilators,infraredthermometers)onthewebsiteoftheStateFoodandDrugAdministration;eachprovincialdrugregulatoryauthorityshalldesignateSpecialpersonisresponsibleforinformationreporting.Thethirdistoaccuratelygraspthelegalpositioningandstandardizetheexportsalescertification.EnterprisesthathavenotobtainedamedicaldeviceregistrationcertificateandproductionlicenseinChina,orhavenotfiledmedicaldeviceproductrecordsandproductionrecords,willnotbeissuedexportsalescertificates.Thefourthistoorganizethesystemtobecapableandtoincreasesupervisionandinspection.Provincialdrugregulatorydepartmentsshouldquicklymobilizetheresourcesofthewholeprovince,establishalistsystemformedicaldeviceproductionandoperationenterprisesandaresponsibilitysystemforsupervisors,focusonkeylinks,focusonkeyissues,strengthencontrolmeasures,andallevidenceindicatesthequalityofexportedproductsIfthereisaproblem,itisnecessarytoimmediatelystopproduction,rectify,andinvestigatetheproblem.Iftheproblemsarenotverifiedandtheresponsibilitiesarenotclearlydefined,theproductionandoperationshallnotberesumed.Fifth,highlightthesupervisionofexportproductsandstrengthensupervisionandrandominspection.Provincialdrugregulatorydepartmentsshouldappropriatelyadjustthesamplinginspectionitemsaccordingtotheneedsofepidemicpreventionandcontrolandtheneedtoensurethequalityofexportedproducts.Samplinginspectionshouldcoverallkindsofproductsproducedbyenterprisesinthisprovince,especiallythoseproductsnewlyapprovedbyenterprisesduringtheepidemicpreventionandcontrolperiod.Themeetingalsorequiredthatdrugregulatoryauthoritiesatalllevelsshouldstrictlyfollowtherequirementsofmedicaldevicereviewandapprovalunderthepremiseofensuringproductsafety,effectivenessandqualitycontrol,andstrictlyfollowthesysteminspection,registrationinspection,clinicaltrials,andtechnology.Intheprocessofreviewandadministrativeexaminationandapproval,thereviewandapprovalofequipmentforepidemicpreventionandcontrolshouldbedoneinanorderlymannertoensureproductsafety,effectivenessandcontrollablequality.Inresponsetoviolationsdiscoveredduringsupervision,themeetingemphasizedtheneedtoimplementthe"fourmoststringent"requirements,strictlyimplementcorporateresponsibilityandterritorialmanagementresponsibilities,andinvestigateandde

Categories:Industry News
Author:
Origin:
Time of issue:2020-05-13
Views:0

On April 3, the State Food and Drug Administration convened a special video and telephone conference to strengthen the quality control of the export of medical devices for epidemic prevention and control, and re-emphasized, re-deployed, and implemented the quality control of the export of medical devices for epidemic prevention and control. The meeting emphasized that the whole system should further improve the political position, comprehensively implement the spirit of the important speech of General Secretary Jinping and the decision-making and deployment of the Party Central Committee and the State Council, in accordance with the requirements of the Ministry of Commerce, the General Administration of Customs, and the State Food and Drug Administration for the orderly development of medical supplies , Comprehensively strengthen the quality control of the export of medical devices for epidemic prevention and control, and effectively guarantee the quality and safety of exported medical devices. Xu Jinghe, deputy director of the State Food and Drug Administration, attended and delivered a speech.

Xu Jinghe pointed out that at present, the international epidemic situation is showing the trend of accelerating the spread and spread, and the number of medical devices required for global prevention and control of the epidemic has increased dramatically. On the basis of fully satisfying the needs of domestic epidemic prevention and control products, China's epidemic prevention and control medical device products have gone abroad to help international epidemic prevention and control. Ensuring the quality of medical device products for epidemic prevention and control is a matter of national image and international reputation. The whole system must deeply understand the great significance of the central government to ensure the quality of medical equipment products for export epidemic prevention and control, correctly handle the relationship between national interests and corporate interests, the relationship between local interests and overall interests, the relationship between immediate interests and long-term interests, and do all it can to export Product quality supervision work effectively guarantees the quality and safety of exported medical device products.

The meeting clearly required: First, we must quickly find out the situation of the enterprise and ensure that the focus of supervision is focused. Provincial drug regulatory departments should establish a list of exporting medical device companies, implement dynamic adjustments, and export medical device products to medical device manufacturers and operating companies, be aware of them; supervise and guide export companies to improve export product files, and effectively ensure the product export process Traceability; promptly notify the government of the locality of the exporting enterprise of the list of exporting enterprises. The second is to determine the person responsible for reporting to ensure the quality of information disclosure. The State Administration has continuously registered 5 types of products approved by the drug regulatory authority (new crown virus detection reagents, medical protective clothing, medical masks, ventilators, infrared thermometers) on the website of the State Food and Drug Administration; each provincial drug regulatory authority shall designate Special person is responsible for information reporting. The third is to accurately grasp the legal positioning and standardize the export sales certification. Enterprises that have not obtained a medical device registration certificate and production license in China, or have not filed medical device product records and production records, will not be issued export sales certificates. The fourth is to organize the system to be capable and to increase supervision and inspection. Provincial drug regulatory departments should quickly mobilize the resources of the whole province, establish a list system for medical device production and operation enterprises and a responsibility system for supervisors, focus on key links, focus on key issues, strengthen control measures, and all evidence indicates the quality of exported products If there is a problem, it is necessary to immediately stop production, rectify, and investigate the problem. If the problems are not verified and the responsibilities are not clearly defined, the production and operation shall not be resumed. Fifth, highlight the supervision of export products and strengthen supervision and random inspection. Provincial drug regulatory departments should appropriately adjust the sampling inspection items according to the needs of epidemic prevention and control and the need to ensure the quality of exported products. Sampling inspection should cover all kinds of products produced by enterprises in this province, especially those products newly approved by enterprises during the epidemic prevention and control period.

The meeting also required that drug regulatory authorities at all levels should strictly follow the requirements of medical device review and approval under the premise of ensuring product safety, effectiveness and quality control, and strictly follow the system inspection, registration inspection, clinical trials, and technology. In the process of review and administrative examination and approval, the review and approval of equipment for epidemic prevention and control should be done in an orderly manner to ensure product safety, effectiveness and controllable quality.

In response to violations discovered during supervision, the meeting emphasized the need to implement the "four most stringent" requirements, strictly implement corporate responsibility and territorial management responsibilities, and investigate and deal with cases of violations, and severely punish them in accordance with the law. Strengthen the supervision of listing of major cases, strengthen the connection of execution of cases, highlight the punishment of people for illegal acts, and form a high-pressure situation and deterrent power.

It is reported that the State Food and Drug Administration will form a joint supervision group with the relevant departments of the General Administration of Market Supervision to conduct special supervision in some areas where the export volume of medical equipment for epidemic prevention and control is relatively large, and incorporate the quality supervision of export products of medical equipment for epidemic prevention and control in various regions. Annual assessment and evaluation.

At the meeting, relevant persons in charge of Jiangsu, Zhejiang, Shandong, and Guangdong Provincial Food and Drug Administrations made statements on comprehensively strengthening the export quality control of medical devices for epidemic prevention and control.

Persons in charge of relevant departments of the State Administration of Food and Drug Administration, directly affiliated units and related personnel attended the meeting; relevant persons in charge of the drug supervision bureaus of the provinces (autonomous regions and municipalities) and Xinjiang Production and Construction Corps, relevant departments, persons in charge of directly affiliated units and related personnel Attend the meeting in the branch.

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