中新网9月29日电 据卫生部网站消息，卫生部日前起就《高值医用耗材集中采购工作规范(试行)》(征求意见稿)公开征求意见。意见稿强调，集中采购工作应当遵循公开透明、公平竞争、公正廉洁和科学诚信原则，保证医用耗材生产经营企业平等参与，禁止任何形式的地方保护。

Beijing on September 29, according to the ministry of health news website,Ministry of health has since[The high value of medical consumable centralized purchasing work specification(trial)](draft)Public to solicit their opinions.Opinion draft to emphasize,Centralized procurement shall follow the transparent/Fair competition/Impartial and honest and science and the principle of good faith,Ensure that medical consumables production management enterprise equal participation,Prohibit any form of local protection.

　　意见稿具体内容如下：

The draft specific content as follows:

　　

《高值医用耗材集中采购工作规范(试行)》(征求意见稿) [The high value of medical consumable centralized purchasing work specification(trial)](draft)

　　

第一章  总则 The first chapter  General rules

　　第一条  为进一步规范高值医用耗材集中采购工作，明确当事人的行为规范，依据有关法律法规，制订本规范。

Article 1  For the purpose of further regulating the high value of medical consumable centralized purchasing work,Clear the code of conduct,In accordance with relevant laws and regulations,Make this code.

　　第二条  本规范所指高值医用耗材是指直接作用于人体、对安全性有严格要求、临床使用量大、价格相对较高、社会反映强烈的医用耗材。参考目录详见附表。

Article 2  This specification refers to high value medical consumables is refers to the direct role in the human body/Has the strict request to safety/Clinical usage big/Value is relative taller/Social reflect strong medical consumables.Reference catalogue see attached list.

　　第三条  县级及县级以上人民政府、国有企业(含国有控股企业)等举办的有资质的非营利性医疗机构采购高值医用耗材，必须全部参加集中采购。

Article 3  And the people's government at or above the county level at or above the county level/State-owned enterprise(Including state-owned holding enterprise)Held such as qualified non-profit medical institutions purchasing high value medical consumables,All must participate in centralized purchasing.

　　第四条  实行以政府为主导、以省(区、市)为单位的网上高值医用耗材集中采购(以下简称集中采购)工作。医疗机构和医用耗材生产经营企业必须通过各省(区、市)建立的集中采购工作平台开展采购，实行统一组织、统一平台和统一监管。研究探索部分省(区、市)联合开展集中采购的方式。

Article 4 the  Implement the government as the leading/To save(area/city)As the unit of online high value medical consumable centralized purchasing(Hereinafter referred to as the "centralized procurement)work.Medical institutions and medical consumables production management enterprise must through the provinces(area/city)The establishment of centralized purchasing work platform to carry out purchasing,Unified organization/Unified platform and unified supervision.Study part of the province(area/city)Combine to centralized purchasing way.

　　第五条  集中采购工作应当遵循公开透明、公平竞争、公正廉洁和科学诚信原则，保证医用耗材生产经营企业平等参与，禁止任何形式的地方保护。

Article 5  Centralized procurement shall follow the transparent/Fair competition/Impartial and honest and science and the principle of good faith,Ensure that medical consumables production management enterprise equal participation,Prohibit any form of local protection.

　　第六条  集中采购周期原则上为两年一次。开展产品增补工作期限不得超过一年。

Article 6  Centralized purchasing cycle in principle for two years once.Carry out product supplementary work period shall not exceed one year.

　　第七条  依照本规范需要进行集中采购的高值医用耗材，有下列情形之一的，可以不实行集中采购：

Article 7  In accordance with the standard the need for centralized purchase of medical disposable materials of high value,One of the following situations occurs,Can not implement centralized purchasing:

　　(一)因战争、自然灾害等，需进行紧急采购的；

(a)Because of the war/Natural disasters,Need to make an emergency procurement;

　　(二)发生重大疫情、重大事故等，需进行紧急采购的；

(two)Produces major epidemic/Serious accidents,Need to make an emergency procurement;

　　(三)卫生部和省级卫生行政部门认定的其他情形。

(three)The ministry of health and the administrative department of health at the provincial level other circumstances recognized.

　　

第二章  集中采购机构 The second chapter  Centralized procurement institutions

　　第八条  各省(区、市)人民政府不再新设集中采购机构，沿用现有药品集中采购工作领导机构、管理机构、工作机构和监督机构，依据有关法律法规开展工作。

Article 8  provinces(area/city)People's government no longer new set of centralized procurement institutions,Continue to use existing drug centralized purchasing lead agency/Management mechanism/Working mechanism and supervision mechanism,In accordance with relevant laws and regulations to begin the work.

　　第九条  集中采购领导机构负责制订本省(区、市)集中采购工作的实施意见和监督管理办法，研究集中采购工作的重大问题，协调并督促各部门按照各自职责做好集中采购相关工作。

Article 9  Centralized purchasing lead agency responsible for establishing the province(area/city)The implementation of centralized purchasing work opinion and supervision and management measures,Research on major issues in the work of centralized purchasing,Coordinate and supervise each department in accordance with their respective duties to centralized purchasing related work.

　　第十条  集中采购管理机构主要职责是制订计划和规则、组织管理、监督检查。

Article 10  Centralized purchasing management agency main duty is to make plan and rules/Organization management/Supervision and inspection.

　　(一)按照领导机构的要求，根据各省(区、市)医疗需求情况，制订年度集中采购计划、采购产品类别和工作方案。未列入当次采购周期集中采购计划的高值医用耗材，各地(市)报集中采购管理机构备案后，可以自行组织采购；

(a)According to the requirements of the lead agency,According to the provinces(area/city)Medical demand,Making annual centralized purchasing plan/Purchase product category and work plan.When time not listed in the purchasing cycle centralized purchasing plan of high value medical consumables,around(city)Quote centralized purchasing management institutions after the record,Can purchase their own organizations;

　　(二)   组织、协调、推动本省(区、市)集中采购工作；

(two)   organization/coordination/Promote the province(area/city)Centralized purchasing work;

　　(三)组建并管理本省(区、市)集中采购专家库；

(three)Set up and manage the province(area/city)Centralized procurement expert database;

　　(四)指导、管理并监督集中采购工作机构按照规定程序，公开、公平、公正地开展集中采购工作；

(four)guidance/Management and supervision of the centralized procurement institutions shall, in accordance with stipulated procedures,public/fair/Justice to carry out the centralized purchasing work;

　　(五)审核集中采购工作机构报送的集中采购文件及集中采购结果等；

(five)Audit institutions to submit the centralized purchasing work of centralized purchasing documents and centralized purchasing results, etc;

　　(六)组织对医疗机构和医用耗材生产经营企业的履约情况进行监督检查；

(six)Organization for medical institutions and medical consumables production management enterprise performance situation of supervision and inspection;

　　(七)   调查、处理相关投诉和举报；

(seven)   survey/Processing related complaints and reports;

　　(八)   向集中采购领导机构负责并报告工作；

(eight)   Centralized purchasing lead agency to be responsible and report on their work;

　　(九)承办集中采购领导机构交办的其他事项。

(nine)The centralized purchasing lead agency turns over the handling other matters.

　　第十一条  集中采购工作机构接受集中采购管理机构的领导，负责本省(区、市)集中采购工作的具体实施，建立完善的管理体制、工作制度、工作守则和工作流程。主要职责包括：

Article 11  Centralized procurement institutions accept the leadership of centralized purchasing management institution,Responsible for the province(area/city)Specific measures for the implementation of centralized purchasing work,Establishing a perfect management system/Working system/Working rules and work process.The main responsibility is include:

　　(一)根据集中采购工作方案制订采购实施细则，编制集中采购文件，报集中采购管理机构审核通过后公布；

(a)According to the centralized purchasing work for the detailed rules for the implementation of purchasing plan,Prepare centralized purchasing documents,Quote centralized purchasing management institution after passing the review published;

　　(二)受理医用耗材生产经营企业资质证明文件、产品资质证明文件等，并协助有关部门进行审核；

(two)Accept medical consumables production management enterprise qualification certificate/Product qualification certification documents, etc,And to assist in the relevant departments to audit;

　　(三)   组织实施产品填报、网上报价和产品遴选等工

(three)   Implement product fill/Quotes online and product selection work, etc

　　作；

for;

　　(四)   报集中采购管理机构审定并公告集中采购结果；

(four)   Centralized purchasing management mechanism for examination and approval and announcement centralized purchasing results;

　　(五)督促医疗机构与医用耗材生产经营企业按照集中采购结果签订购销合同，并协助集中采购管理机构监督合同的执行；

(five)Supervise and urge medical institutions and medical consumables production management enterprise according to the centralized purchasing signed purchase and sales contract,And to assist in the centralized purchasing management institution supervises the implementation of the contracts;

　　(六)负责本省(区、市)集中采购工作平台的技术管理、网络安全、数据和设备的维护，提供相关的服务和技术支持；

(six)Responsible for the province(area/city)Centralized purchasing work platform technology management/Network security/Data and equipment maintenance,Provide the related service and technical support;

　　(七)为医疗机构和医用耗材生产经营企业提供咨询服务；

(seven)For medical institutions and medical consumables production management enterprise to provide advisory services;

　　(八)定期统计分析本省(区、市)医疗机构和医用耗材生产经营企业网上采购、配送、回款等情况，做好网上监控；

(eight)Statistical analysis on a regular basis in the province(area/city)Medical institutions and medical consumables production management enterprise online purchase/distribution/Collection, etc,Do online monitoring;

　　(九)   组织相关业务技术培训；

(nine)   Organize the related business technical training;

　　(十)   协助调查和处理相关申投诉和举报；

(ten)   To assist in the investigation and handling relevant "complaints and reports;

　　(十一)向集中采购管理机构负责并报告工作情况；

(eleven)To the centralized purchasing management institution shall be responsible and report its work situation;

　　(十二)负责集中采购工作相关资料归档和保存；

(twelve)Responsible for the centralized purchasing work related data archiving and preservation;

　　(十三)承办集中采购管理机构交办的其他事项。

(13)The centralized purchasing management institutions other matters assigned by the.

　　第十二条  集中采购监督机构对参与集中采购工作的部门、机构、人员以及工作全过程进行监督管理。

Article 12  Centralized purchasing in supervising agencies for centralized purchasing department/institutions/Personnel and the working process of supervision and management.