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关于2002版《医疗器械分类目录》有关问题的批复

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关于2002版《医疗器械分类目录》有关问题的批复

国家食品药品监督管理局


关于2002版《医疗器械分类目录》有关问题的批复


国药监械[2002]410号

北京市药品监督管理局:

你局《关于新版〈医疗器械分类目录〉中几点问题的请示》(京药监械〔2002〕29号)收悉,现批复如下:

一、97版《目录》包括而2002版《目录》未包括的产品,原则上不再作为医疗器械管理;

二、按97版《目录》已注册的产品,如该产品上市后无不良事件,可待该产品注册证到期时,再按2002版《目录》类别要求换证;

三、接骨螺钉见骨钉(6846-1),功能辅助装置见器官辅助装置(6846-5),医用夹板为I内产品,序号为6864-3;

四、使用已注册的义齿材料生产的义齿为Ⅱ类医疗器械,序号为6863-16;

五、一次性使用活检针为Ⅲ类医疗器械,可重复使用活检针为Ⅱ类医疗器械,序号为6815;

六、无创监护仪器为Ⅱ类医疗器械;

七、医用卫生材料及敷料(无菌或非无菌)均执行2002版《目录》;

八、在没有制定新的体外诊断试剂分类规定前,体外诊断试剂暂按Ⅲ类产品管理;

九、2002版《目录》中煮沸消毒设备的序号为6857-7,牙周塞治剂与根管充填材料使用相同的序号(6863-3)。


国家药品监督管理局
二○○二年十一月十二日



浙江省保护老年人合法权益若干规定

浙江省人大常委会


浙江省保护老年人合法权益若干规定
浙江省人大常委会


(1988年7月23日浙江省第七届人民代表大会常务委员会第四次会议通过)


第一条 为了切实保护老年人的合法权益,根据宪法和有关法律、法规规定,结合本省实际情况,制定本规定。
第二条 保护老年人的合法权益,树立敬老、助老、养老的社会风尚,是全社会的共同责任。
一切国家机关、企业事业单位、社会团体和基层群众性自治组织以及全体公民,都应当关心老年人的生活,保护老年人的合法权益。
新闻单位应积极开展敬老宣传,对侵犯老年人合法权益的行为实行舆论监督。
第三条 老年人的人身自由和人格尊严受法律保护,任何单位和个人不得侵犯。严禁打骂、侮辱、诽谤、虐待、遗弃和非法拘禁老年人。
第四条 老年人婚姻自由的权利受法律保护。任何单位和个人不得干涉老年人依法离婚,不得干涉离婚、丧偶的老年人再婚,不得干扰、妨害老年人再婚后的家庭生活。
第五条 老年人受赡养扶助的权利受法律保护。依法负有赡养扶助义务的成年子女,必须履行赡养扶助的义务。
(一)对没有经济收入或者经济收入低微的老年人,成年子女应保障其基本生活需要,一般不低于当地平均生活水平;
(二)对缺乏或者丧失劳动能力的农村老年人的口粮田、自留地,成年子女应帮助耕种,或者支付费用请人代为耕种;
(三)对患有疾病或者生活不能自理的老年人,成年子女应负责给予治疗、照料,或者支付费用请人代为照料;
(四)老年人再婚后,其依法负有赡养扶助义务的成年子女应继续履行赡养扶助的义务。
第六条 老年人的房产权和居住权受法律保护。
(一)子女和其他亲属不得强行挤占老年人的住房,不得强行改变老年人的居住条件;
(二)未经老年人同意,子女和其他亲属不得擅自改变由老年人承租的住房租赁关系;
(三)未经老年人同意,子女和其他亲属不得将产权属于老年人的房屋出卖、出租或者拆除;
(四)子女所在单位分配的住房,含老年人份额的,老年人有权居住。
第七条 老年人的财产权利受法律保护。
(一)老年人的合法收入和储蓄、生活用品、文物、图书资料、知识产权、林木、牲畜、家禽以及其他合法财产,任何单位和个人不得侵占、哄抢、私分和破坏;
(二)老年人有权拒绝有独立生活能力的成年子女提出的经济资助的要求。子女和其他亲属不得向老年人强行索取财物;

(三)老年人再婚时,有权携带和处理依法应归其所有的财产;
(四)老年人依法享有的继承权,子女和其他亲属不得侵犯。老年人依法立遗嘱处分个人财产或者与他人签订遗赠扶养协议的,子女和其他亲属不得干涉。
第八条 离休、退休人员依法享有国家规定的离休工资、退休费以及医疗、福利等方面的待遇。
第九条 老年人没有经济收入并无子女、亲属供养的,有从国家和社会获得物质帮助的权利。在城镇,由当地政府的民政部门和街道办事处发给生活救济补助金;在农村,实行保吃、保穿、保住、保医、保葬制度,保障他们的基本生活需要,其经费由乡(镇)人民政府和村民委员会统
筹解决。
第十条 市、县(区)、乡(镇)人民政府和城镇街道办事处应积极创造条件,兴办社会福利院、敬老院、老年人公寓等为老年人服务的福利设施。
政府有关部门和社会团体,应积极兴办老年人的活动场所,组织老年人开展文化、体育、娱乐活动。
鼓励有条件的单位和个人兴办为老年人服务的福利设施和老年人活动场所。
第十一条 工商企业应积极生产和经营老年人需要的生活用品,设立为老年人服务的项目,提供良好的服务,方便老年人的生活。
第十二条 公共交通部门应积极开展对老年乘客的特殊服务,设置必要的设施,为老年人乘车、乘船等提供方便。
第十三条 医疗卫生部门应热情、认真为老年病人治疗;有条件的地方应设立老年病专科门诊,积极发展老年病防治康复医疗事业。
第十四条 律师事务所(法律顾问处)对于没有经济收入或者经济收入低微的老年人提出的法律咨询,应提供免费服务。
第十五条 国家机关、企业事业单位、社会团体和基层群众性自治组织,应鼓励和支持老年人自愿参加力所能及的社会活动。
第十六条 农历九月初九(重阳节)为本省老人节。
每年老人节,举行各种敬老活动。各级人民政府对模范老人和保护老年人合法权益、为老年人提供服务作出显著成绩的单位和个人给予表彰、奖励。
第十七条 市、县(区)和乡(镇)可设立老年人协会。老年人协会是由老年人自愿组成的、反映老年人的要求、保护老年人的合法权益的群众组织。
第十八条 积极提倡家庭和睦、邻里互助,正确处理老年人与亲属之间、邻里之间的相互关系,创造和谐的生活环境。

第十九条 对侵犯老年人合法权益的行为,任何单位和个人都有权制止和检举。受侵害的老年人有权提出控告或者依法提起诉讼。
有关部门、单位对侵害老年人合法权益行为的检举、控告,应当及时认真查处,不得推诿。因玩忽职守,造成严重后果的,依法追究直接责任者的责任。
第二十条 对因赡养扶助发生的纠纷,以及其他损害老年人合法权益的事件,村(居)民委员会、乡(镇)人民政府和城镇街道办事处以及当事人所在单位应当依法及时进行调解;当事人也可以直接向人民法院起诉。人民法院应当依法及时审理。
第二十一条 违反本规定第三条至第七条的,由其所在单位或者基层群众性自治组织给予批评教育,或者由其所在单位给予行政处分,并依法承担民事责任;违反治安管理处罚条例的,由公安机关依照《中华人民共和国治安管理处罚条例》予以处罚;情节严重构成犯罪的,由司法机关
依法追究刑事责任。
第二十二条 本规定由各级人民政府的民政、劳动人事部门具体负责实施。
第二十三条 本规定自1988年9月1日起施行。



1988年7月25日

江西省企业投资项目备案办法

江西省人民政府


江西省企业投资项目备案办法(附:英文译本)



  《江西省企业投资项目备案办法》已经2006年4月12日省人民政府第43次常务会议审议通过,现予公布施行。
     省长 黄智权
       二○○六年四月十四日
  
       江西省企业投资项目备案办法
  
  第一条 为规范企业投资项目的备案管理,落实企业投资决策自主权,根据《国务院关于投资体制改革的决定》和《国家发展改革委关于实行企业投资项目备案制指导意见的通知》,结合本省实际,制定本办法。
  第二条 本省行政区域内企业投资项目的备案,适用本办法。
  本办法所称的企业投资项目,是指企业不使用政府性资金,投资建设国务院颁布的《政府核准的投资项目目录》、《江西省政府核准的投资项目目录》以及国家法律法规和国务院专门规定禁止投资以外的项目。
  第三条 县级以上人民政府发展改革(计划)行政主管部门和经济贸易行政主管部门为企业投资项目备案机关。企业基本建设类投资项目由发展改革(计划)行政主管部门备案;企业技术改造类投资项目由经济贸易行政主管部门备案。
  环境保护、国土资源、城市规划、安全生产监督管理等有关部门,应当在各自职责范围内协助做好企业投资项目备案工作。
  项目备案机关和有关部门应当建立信息共享机制,加强联系和沟通,为企业投资提供便利。
  第四条 企业投资建设实行备案制的项目,应当根据项目类别和规定的备案权限,向相应的项目备案机关申请备案。
  第五条 中央驻赣企业、省管企业投资项目由省人民政府项目备案机关备案。其他企业投资项目,按照属地原则,由项目所在地市、县(区)人民政府项目备案机关备案。法律、法规或者规章另有规定的,从其规定。
  设区市与县(市、区)人民政府项目备案机关备案权限的划分,由各设区市人民政府确定。
  第六条 项目申报单位申请备案,应当向项目备案机关提交企业投资项目备案申请表。
  企业投资项目备案申请表包括下列内容:
  (一)项目申报单位基本情况;
  (二)项目名称;
  (三)建设性质;
  (四)建设地点;
  (四)建设规模和主要建设内容;
  (五)总投资和资金来源。
  项目申报单位应当对企业投资项目备案申请表内容的真实性负责。
  第七条 项目备案机关应当将企业投资项目备案所涉及的法律、法规、规章和政策,以及企业投资项目备案申请表格式文本予以公布,方便企业查询、索取。
  第八条 项目备案机关对企业投资项目的下列内容进行审查:
  (一)是否属于备案范围;
  (二)是否属于本机关管辖范围;
  (三)是否符合国家产业政策;
  (四)是否符合法律、法规、规章的规定。
  第九条 企业投资项目备案申请表不符合要求的,项目备案机关应当当场或者在3个工作日内一次告知项目申报单位补正。
  企业投资项目备案申请表符合要求的,项目备案机关应当当场受理。
  第十条 项目备案机关应当自受理企业投资项目备案申请之日起5个工作日内,作出是否备案的决定,并向社会公布。符合备案规定的,予以备案,发给企业投资项目备案通知书;不符合备案规定的,不予备案,发给不予备案通知书,并说明理由。
  项目备案机关应当将企业投资项目备案通知书和不予备案通知书抄送相关行政主管部门。
  第十一条 环境保护、国土资源、建设、城市规划、安全生产监督管理、质量监督等部门,应当按照职能分工,对项目备案机关予以备案的项目依法审查和办理相关手续;对应当备案而未备案以及项目备案机关不予备案的项目,不予办理相关手续。
  第十二条 各级项目备案机关应当对企业投资项目的备案材料进行整理、归纳、分析,做好社会投资的监测工作,并及时向上级项目备案机关报送相关材料。
  第十三条 已备案项目有下列情形之一的,应当重新办理备案手续:
  (一)项目法人发生变化的;
  (二)建设地点发生变更的;
  (三)变更建设方案可能对环境、安全生产等产生重大不利影响的。
  第十四条 企业投资项目备案通知书的有效期为2年,自送达之日起计算。
  企业投资项目在备案通知书有效期内未开工的,项目申报单位需要继续建设,应当在有效期届满前30日内向原项目备案机关申请延续,原项目备案机关应当在备案通知书有效期届满前作出是否准予延续的决定。
  第十五条 项目备案机关应当加强备案项目的监管,对项目申报单位以拆分项目、提供虚假材料等不正当手段取得企业投资项目备案文件的,应当撤销该项目的备案;对未予备案擅自开工建设以及不按备案内容进行建设的项目,应当责令其停止建设,并依法追究有关单位和责任人的责任。
  第十六条 项目备案机关工作人员在备案过程中玩忽职守、滥用职权或者徇私舞弊的,依法给予行政处分;构成犯罪的,依法追究刑事责任。
  第十七条 事业单位、社会团体等非企业单位投资建设备案范围内的项目,按照本办法进行备案。
  第十八条 本办法自公布之日起施行。

英文译本
Decree of the People’s
Government of Jiangxi Province
No.
146
Measures of Jiangxi Province for
Record-keeping of Enterprise Investment Projects examined and approved at the
43rd Executive Meeting of the People’s Government of Jiangxi Province on April
12, 2006 are hereby promulgated and shall be effective as of the date of
promulgation.

Governor: Huang
Zhiquan
April 14,
2006
Measures of Jiangxi
Province for Record-keeping of Enterprise Investment
Projects
Article 1These Measures are formulated in accordance with the
Decision of the State Council on the Reform of the Investment System and the
Circular of the National Development and Reform Commission about the Guidelines
for Implementing the Record-keeping System of Enterprise Investment Projects
with actual situations of the province taken into account for the purpose of
standardizing the record management of the enterprise investment projects and
facilitating the exercise of
autonomous decision-making right of enterprises in
investment.
Article 2These Measures apply to reporting for the record of the
enterprise investment projects within the administrative areas of the
province.
The term
“enterprise investment projects” in these Measures refers only to the projects
(which are free of government funds) listed in《Catalogue of
Investment Projects Approved by the Government》and《Catalogue of
Investment Projects Approved by the Government of Jiangxi
Province》;it also refers
to all other projects with the exception of those in violation of state laws and
regulations or prohibited by the State Council.
Article 3The administrative competent
departments of development and reform (planning) and the administrative
competent departments of economy and trade of the people’s governments at or
above the county level are the record-keeping organs for enterprise investment
projects. The competent departments of development and reform (planning) of the
people’s governments are responsible for the record-keeping of capital
construction of the enterprise investment projects; the competent departments of
economy and trade are responsible for the record-keeping of technical renovation
for the enterprise investment projects.
The departments
responsible for environmental protection, national land resource management,
urban planning, supervision and management of safe production shall assist with
the record-keeping of the enterprise investment projects within their respective
realms of functions and
duties.
The
record-keeping organs and the relevant departments shall establish an
information-sharing mechanism strengthening connection and communication between
them for the sake of facilitating the enterprise
investment.
Article 4The enterprise investment projects which need to report
for the record shall apply to the corresponding record-keeping organs for being
reported for the record according to the project category and prescribed extent
of power in record-keeping.
Article 5The investment projects of the Jiangxi-based state-run
enterprises and the provincial enterprises are reported for the record to the
record-keeping organ of the provincial people’s government. Other enterprise
investment projects are reported for the record to the record-keeping organs of
people’s governments of the prefecture, municipality or county (district) where
the projects exist according to the domicile principle. However, if otherwise
specifically provided by laws, regulations or rules, they shall
prevail.
The division of
the power extent of the record-keeping organs of the municipality with
subordinate administrative areas and county (municipality, region) people’s
governments is defined by the people’s government of the municipality with
subordinate administrative areas.
Article 6Any project unit which reports for the record shall
submit an application form of enterprise investment project to the
record-keeping organ.
The application
form of enterprise investment project includes the following
contents:
(1) the basic
conditions of the project application unit;
(2) the name of the
project;
(3) construction
nature;
(4) construction
site;
(5) construction scale
and the main construction contents; and
(6) total investment
and its source.
The project
application unit shall be responsible for the genuineness of the contents in the
application form of enterprise investment project.
Article 7The record-keeping organs shall make public the laws,
regulations, rules and policies concerning the record-keeping of enterprise
investment projects and the application form format for the record-keeping of
enterprise investment projects to make them accessible to the enterprises on
request.
Article 8The record-keeping organs shall examine the following
contents of the enterprise investment projects:
(1) whether the
projects are within the scope of the record;
(2) whether the
projects are within the scope of their
jurisdiction;
(3) whether the
projects conform to the national industry policy; and
(4) whether the
projects conform to the stipulations of laws, regulations and
rules.
Article 9Where the application form of the enterprise investment
project does not meet the requirements, the record-keeping organ shall ask the
project application unit to make corrections and amendments on the spot or once
and for all within three working days.
Where the
application form of the enterprise investment project meets the requirements,
the record-keeping organ shall accept the application on the
spot.
Article 10The record-keeping organ shall decide whether to accept
the record application or not within five days from the date of acceptance of
the application for reporting for the record of the enterprise investment
project and make it known to the society. If the application conforms to the
stipulations for record-keeping, the record-keeping organ shall accept the
application, notifying the applicant of its decision to put on record the enterprise investment project; if the
application does not conform to the stipulations for record-keeping, the
record-keeping organ shall not accept the application, notifying the applicant
of its decision to not accept to put on record the enterprise investment project
together with the reasons for it.
The
record-keeping organ shall send a copy of the notice of accepting or not
accepting the record application of the enterprise investment project to the
relevant administrative competent departments.
Article 11The departments responsible for environmental
protection, national land resource management, urban planning, supervision and
management of safe production shall examine projects filed on record by the
record-keeping organs and handle the relevant procedures according to laws and
their respective functions and duties. As for the projects which should have
been reported for the record but have not been done so or the projects whose
applications were not accepted by the record-keeping organs, those departments
shall not handle the relevant procedures.
Article 12The record-keeping organs at the different levels shall
sort out, classify and analyze the recorded materials of the enterprise
investment projects, keep a close watch on the social investment and submit the
relevant data to the higher record-keeping organs on time.
Article 13Where projects for the record have any one of the
following circumstances, the archival procedures shall be handled
again.
(1) the change of the
legal person of the project;
(2) the change of the
construction site; and
(3) the change of the
construction scheme can produce great negative influence on the environment,
safe production, etc.
Article 14The notice of record-keeping of the enterprise
investment project is valid for two years, starting from the date of
service.
Where the
construction of the enterprise investment project has not started and the
project application unit which needs to undertake the construction shall apply
to the original record-keeping organ for extension of construction within 30
days prior to the expiry of the validity period of the notice. The original
record-keeping organ shall make a decision whether or not to approve the
extension prior to the expiry of the notice .
Article 15The record-keeping organs shall strengthen the
supervision and management of the projects for the record. Where any project
application unit obtains the record-keeping document of the enterprise
investment project by inappropriate means such as dismembering the project,
providing the false materials, etc., the record-keeping organ shall dissolve the
record-keeping of the project. Where any project application unit starts
construction without authorization or constructs the project which is not in
accordance with the record-keeping contents, the record-keeping organ shall
order the unit to stop the construction and investigate the relevant unit and
its responsible person for their legal liability.
Article 16Where a staff member of any organ neglects his duties,
abuses his power or resorts to cheating for his self purposes, he shall be given
an administrative sanction; if a crime is committed, he shall be investigated
for criminal liability.
Article 17The record-keeping of the investment projects of the
non-enterprise units such as public institutions and social organizations, etc.
shall be handled in accordance with these measures.
Article 18Measures shall be effective as of the date of
promulgation.