[news] industry state clearly, these medical devices by the Planning Commission Wei jicai!

近期各种信号显示,大型医用设备正在成为医疗器械领域除高值耗材、IVD之外的另一个重点规范化管理对象。管理方式除了配置许可、使用监管,还有集中采购。
“国务院明确:甲类大型设备 国家卫计委集采”

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日前,国务院印发《“十三五”深化医药卫生体制改革规划》,正式提出要开展大型医疗设备集中采购。无独有偶。近期,国务院办公厅印发了《中央预算单位2017—2018年政府集中采购目录及标准》。依据该文件,今后两年,须由国家卫计委来统一集中采购的项目包括:1、避孕药具类,包括含铜宫内节育器、含药宫内节育器,避孕套,避孕药片剂、避孕药注射液、避孕药栓剂、避孕药凝胶、避孕药膜和皮下埋植避孕剂等;2、大型医用设备,包括正电子发射型断层扫描仪(PET/CT)、正电子发射磁共振成像系统(PET/MR)、内窥镜手术器械控制系统(手术机器人)、伽马射线头部立体定向发射外科治疗系统(头部伽玛刀)、X线立体定向发射治疗系统、螺旋断层放射治疗系统、高端直线加速器、医用电子回旋加速治疗系统、质子治疗系统、306道脑磁图等。
与前两年的《中央预算单位2015-2016年政府集中采购目录及标准》相比,国务院对国家卫计委的集中采购项目作了大调整。

如上,在2017-2018年,国家卫计委的集中采购项目中新增了甲类大型医用设备。此外,《目录》还将政府采购货物、服务项目的公开招标数额标准由原来的120万元提高到200万元,将货物、服务项目的分散采购限额标准由原来的50万元提高到100万元。实际上,国家卫计委早在几年前就开始负责甲类大型设备的集中采购了,而此番算是明确写入了“国字号”文件之中。国家卫计委国际交流与合作中心作为卫计委甲类大型设备集采的具体承担机构,在截至2014年11月的5年里,为29个省(区、市)148家医疗机构集采了192台甲类大型医用设备,总成交额近26亿元。据该部门统计,集中采购降价效果明显,为医疗机构节约了28%的采购预算资金。未来,有了十三五医改规划和国字号文件的强力加持,甲类大型医用设备的集中采购会持续,而乙类大型设备,或将有更多省份如安徽一样实行省级集中采购。价格昂贵的大型医用设备,降价及择低采用也成为大趋势。
“大型医用设备配置许可,走向合法化”
同样是最新消息,据国家卫计委网站1月10日公告,国家卫计委日前批复山西省卫计委《关于发放放射诊疗许可证有关问题的请示》,称大型医用设备配置许可已由非行政许可调整为行政许可,卫计委正在履行新设许可程序,在此期间暂停办理大型医用设备配置许可。多年以来,国家卫计委一直以“非行政许可”的名义,负责甲类大型医用设备的配置许可证核发,省级卫计委则是负责乙类大型医用设备的配置许可证核发。不过,非行政许可一直被认为是不清不楚的,在法律界也存在巨大争议性,被视为灰色地带。新一届政府上台后,李克强总理力推审批改革,取消所有非行政许可事项。这一度引发业内关注,大型医用设备的配置管理会走向何方?完全放开还是进一步规范?国家卫计委最新批复显示,“大型医用设备配置许可证核发”由“非行政许可”转变为了“行政许可”。也即,由卫计委强自保留的不合理的“法外之地”,转变为了合理合法的应有之措施。摆脱掉不清不楚的尴尬地位之后,卫计委对大型医用设备的配置管理,也就将更容易下手了。
“医院擅自配置大型设备,或将罚款”
实际上,未来,卫计委对大型医用设备的配置管理不仅会继续予以规范,还很可能会更加严格。2016年5月,国务院法制办前曾就《医疗器械监督管理条例修正案(送审稿)》公开征求意见。按照该送审稿,医械监管条例将大修,而修订主要内容就是,增加了不少医疗机构配置使用大型医用设备的规定。送审稿设定大型医用设备配置许可。医疗机构配置大型医用设备,应当具备保障医疗质量安全的技术条件、专业人员、配套设施设备等基础,并符合配置规划,取得省级以上卫生计生行政部门核发的配置许可证。对未经许可配置使用大型医用设备、以不当手段取得大型医用设备配置许可、不能保障医疗质量安全未停止使用大型医用设备等行为,送审稿也明确了医疗机构应当承担法律责任的违法情形和相应行政处罚内容。比如,增加规定:“未经许可擅自配置使用大型医用设备的,由县级以上人民政府卫生计生主管部门给予警告、责令停止使用,没收违法所得;违法所得不足1万元的,并处1万元以上5万元以下罚款;违法所得1万元以上的,并处违法所得5倍以上10倍以下罚款;情节严重的,5年内不受理相关责任人及医疗器械使用单位提出的大型医用设备配置许可申请”。如此修改的主要目的,其一是大型医用设备的配置许可管理合法化了,其二是制止医疗机构盲目追求高端设备、竞相拼设备,防止医院从“以药养医”走向“以械补医”。
来源:赛柏蓝器械
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Recent signals show that large medical equipment is becoming the focus of medical devices in addition to high-value consumables, IVD, another focus of standardized management. Management methods in addition to configuration permits, the use of supervision, as well as centralized procurement.
The State Council is clear: a national guard Planning Commission in large equipment
Recently, the State Council issued the 13th Five-Year deepening the reform of medical care system planning , formally proposed to carry out large-scale medical equipment procurement. It happens that there is a similar case。 Recently, the general office of the State Council issued the central budget unit 2017 – 2018 centralized procurement catalog and standards. According to the document, the next two years, must by the State Planning Commission to centralized procurement projects include: 1, contraceptives, including copper IUD, medicated IUD, condoms, contraceptive tablet, pill, pill, pill injection suppository gel, contraceptive film and contraceptive implants; 2, large medical equipment, including positron emission tomography (PET\/CT), positron emission magnetic resonance imaging system (PET\/MR), endoscopic surgical instrument control system (robot), gamma ray stereotactic head emission treatment system (gamma knife), stereotactic radiation therapy system, helical tomotherapy system the high-end medical linear accelerator, electron cyclotron treatment system, proton therapy system, 306 MEG etc..
Compared with the previous two years, the central budget unit 2015-2016 centralized procurement catalog and standards, the State Council made a major adjustment of the National Health Planning Commission centralized procurement projects.
As described above, in 2017-2018 years, the State Planning Commission’s centralized procurement project added a large medical equipment. In addition, the Catalogue will also be the government procurement of goods and services to the public tender amount increased from 1 million 200 thousand yuan to 2 million yuan, the goods and services of the decentralized procurement quota increased from 500 thousand yuan to 1 million yuan. In fact, the State Planning Commission as early as a few years ago for a centralized procurement of large equipment, and this is explicitly written into the Guozihao document. The international exchange and cooperation center of the State Planning Commission as the guardian Planning Commission a large equipment Jicai to undertake specific institutions, in the 5 years ending in November 2014, 29 provinces (autonomous regions and municipalities) in the 148 medical institutions of large medical equipment 192 sets a total turnover of nearly 2 billion 600 million yuan. According to the Department statistics, centralized procurement price effect is obvious, for the medical institutions to save 28% of the procurement budget funds. The future, with the 13th Five-Year health care reform plan and Guozihao document strong blessing, centralized procurement of large medical equipment category will continue, while group B large equipment, or there will be more provinces such as Anhui as the implementation of the provincial centralized procurement. Expensive large medical equipment, lower prices and low selection has become a major trend.
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Large medical equipment configuration permit, toward legalization
众多网站存在大量漏洞,很容易将数据库记录外漏,相信这些机构有研发、采购和部署不少安全技术防范产品,甚至有购买安全服务,可是技术和服务最终是要人来使用,显然这些组织机构没能很好解决人员的安全问题。
The same is the latest news, according to the National Health Planning Commission website January 10th announcement, the State Planning Commission approved the day before the Shanxi Provincial Planning Commission on the issue of licensing medical radiation from, said the configuration of large medical equipment has been licensed by non administrative licensing adjustment for administrative licensing, Planning Commission is fulfilling the new licensing procedures, in the meantime the configuration of the license suspended for large medical equipment. Over the years, the State Planning Commission has been in the name non administrative license, issued for large medical equipment configuration of a license issued by the Provincial Planning Commission is responsible for the group B large medical equipment configuration permits. However, the non administrative license has been considered to be unclear, there is a huge controversy in the legal profession, is regarded as a gray area. After the new government came to power, Premier Li Keqiang pushing the reform of the examination and approval, cancel all non administrative licensing matters. This once sparked concern in the industry, large medical equipment configuration management will go? Fully liberalized or further specification? National Guard Planning Commission latest approval shows that the allocation of large medical equipment configuration issued by non administrative license changed to administrative license. That is, by the Wei Planning Commission since the strong retention of the unreasonable outside the law, the change in order to legitimate and reasonable Ying Youzhi measures. Get rid of the awkward position after the embarrassment, Wei Planning Commission on the allocation of large medical equipment management, it will be easier to start.
Hospital unauthorized disposition of large equipment, or will be fine
In fact, the future, Wei Planning Commission for large medical equipment configuration management will not only continue to be standardized, it is likely to be more stringent. May 2016, the State Council Legislative Affairs Office on the Regulations on the supervision and administration of medical devices amendment (Draft) for public comment. According to the draft regulations, medical overhaul, and the main contents of the amendments is to increase a lot, the allocation of medical institutions use of large medical equipment regulations. Large scale medical equipment allocation. The allocation of medical institutions of large medical equipment, should have the basic technical conditions, guarantee the quality and safety of medical professional personnel, facilities and equipment, and in accordance with the planning, made above the provincial health administrative department issued a permit allocation. The unauthorized use of the configuration of large medical equipment, using improper means to obtain large medical equipment configuration permits, can not guarantee the quality and safety of medical not to stop the use of large medical equipment and other acts of illegal situations draft also clear the medical institution shall bear the legal responsibility of the administrative punishment and the corresponding content. For example, increased stipulates: the unauthorized use of the configuration of large medical equipment, by the people’s governments at or above the county level health administrative departments to give a warning, ordered to stop using, confiscate the illegal income; the illegal income is less than 10 thousand yuan, 10 thousand yuan but not more than 50 thousand yuan fine; the illegal income of more than 10 thousand yuan, and the illegal the 5 times more than 10 times the fine; if the circumstances are serious, large medical equipment configuration permits responsible person and medical devices used to apply for acceptance within 5 years. The main purpose of this revision, one is the configuration of the license management of large medical equipment legalization, second is to avoid the blind pursuit of high-end equipment, medical institutions to fight equipment, prevent from the hospital to take the medicine to fill in the medicine.
Source: Blue Saibo instrument
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