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关于实施《一次性使用无菌医疗器械产品(注、输器具)生产实施细则》的通知

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关于实施《一次性使用无菌医疗器械产品(注、输器具)生产实施细则》的通知

国家食品药品监督管理局


关于实施《一次性使用无菌医疗器械产品(注、输器具)生产实施细则》的通知


国药监械[2001]443号



各省、自治区、直辖市药品监督管理局:

  根据《医疗器械生产企业监督管理办法》和《一次性使用无菌医疗器械监督管理办法》
的相关规定,我局已以国药监械[2001]288号文发布了《一次性使用无菌医疗器械产品
(注、输器具)生产实施细则》(2001年修订,以下简称《细则》),该《细则》是一次性
使用(注、输器具)生产企业申请企业许可和产品注册必须严格执行企业体系考核所实施
的统一企业验收标准。

  为做好一次性使用医疗器械(注、输器具)生产企业的《医疗器械生产企业许可证》
和《医疗器械产品注册证》的换(发)、复查工作,使检查组切实可行地按照《细则》所规
定的企业生产条件检查及评定,我局组织专业人员依照《细则》第7条“检查评定的项目
和内容”中“检查内容与要求”,制定了相应的“检查评分方法”,作为《一次性使用无菌
医疗器械产品(注、输器具)生产实施细则检查评分表》(见附件),现予印发。

  按照《关于印发2001年全国医疗器械监督管理工作会议总结的通知》(药监办[2001]
26号)中提出的意见,强化一次性使用医疗器械监督管理工作,做到把《医疗器械生产企
业许可证》与《医疗器械产品注册证》管理有机结合起来, 企业体系考核执行统一验收标
准,统一现场验收,两证同步发放的原则。现对全国一次性使用无菌医疗器械生产企业的
《医疗器械生产企业许可证》和《医疗器械产品注册证》换(发)证工作要求通知如下:

  一、各省、自治区、直辖市药品监督管理局按照《细则》规定,在一次性使用无菌医
疗器械生产企业检查评定中,应同时执行《一次性使用无菌医疗器械产品(注、输器具)
生产实施细则检查评分表》(见附件)。

  《细则》及《一次性使用无菌医疗器械产品(注、输器具)生产实施细则检查评分表》
的培训工作,由各省、自治区、直辖市药品监督管理局组织进行。

  二、自本通知发布之日起,以各省、自治区、直辖市药品监督管理局为主体,实施本
辖区内的一次性使用无菌医疗器械生产企业换(发)证申请及检查验收工作。一次性使用
无菌医疗器械生产企业换(发)证申请及检查验收的截止时间为:2002年6月30日。2002
年7月1日以后各级药品监督管理部门不再受理现有企业的申请及检查验收。

  三、各省、自治区、直辖市药品监督管理局应在截止期内,从本辖区一次性使用无菌
医疗器械生产企业的实际情况提出企业换(发)证进行生产企业检查验收的工作计划,并
将工作计划及具体安排适时上报我局医疗器械司备案。

  四、依照《细则》完成生产企业检查验收的,各省、自治区、直辖市药品监督管理局
的检查组应负责将《生产企业检查报告》、《产品检测报告》和检查中的实际情况,以《细
则》相应条款的规定要求,上报核发《医疗器械生产企业许可证》的药品监督管理部门。
企业领取《医疗器械生产企业许可证》后,到我局办理《医疗器械产品注册证》。

  五、在各省(区、市)进行企业验收发证期间,我局将不定期组织省与省之间的对口监
督检查和国家药品监督管理局的专项抽查,对监督检查的情况进行通报。存在问题较多的
地区,我局将责令其提出整改意见。

  特此通知


  

   国家药品监督管理局
   二○○一年十月十一日


中华人民共和国城乡建设环境保护部关于外国人私有房屋管理的若干规定(附英文)

城建环保部


中华人民共和国城乡建设环境保护部关于外国人私有房屋管理的若干规定(附英文)

1984年8月25日,城建环保部

规定
为加强对外国人在中国境内私有房屋的管理,保护房屋所有人的合法权益,根据有关法规,对若干问题作如下规定:
一、对外国人在中国境内的个人所有、数人共有的自用或出租的住宅和非住宅用房(以下简称外国人私有房屋)的管理,应当遵守《城市私有房屋管理条例》的规定。
二、外国人私有房屋的所有人,须到房屋所在地人民政府房地产管理机关(以下简称房管机关)办理房屋所有权登记手续,经审查核实后,领取房屋所有权证;房屋所有权转移、房屋现状变更或所有人国籍变更时,须到房屋所在地房管机关办理所有权转移或变更登记手续。
三、办理外国人私有房屋所有权登记或转移、变更登记手续时,须提交国籍、职业证明和下列证件:
(一)新建、翻建和扩建的房屋,须提交房屋所在地规划管理部门批准的建设许可证和建筑图纸;
(二)购买的房屋,须提交原房屋所有权证、买卖合同和契证;
(三)受赠的房屋,须提交原房屋所有权证、赠与书或遗赠证件和契证;
(四)交换的房屋,须提交双方的房屋所有权证、双方签订的协议书和契证;
(五)继承的房屋,须提交原房屋所有权证、遗产继承证件和契证;
(六)分家析产、分割的房屋,须提交原房屋所有权证、分家析产单或分割单和契证;
(七)获准拆除的房屋,须提交原房屋所有权证和批准拆除证件。
证件不全或房屋所有权不清楚的,暂缓登记,待条件成熟后办理。
四、外国人私有房屋出租或出借,其租赁合同或出借凭证,应当送交房屋所在地房管机关备案。
五、外国人私有房屋所有人不能亲自办理房屋所有权登记或转移、变更登记手续时,可以委托代理人或中国律师代为办理,委托代理应由本人出具委托书。
外国人私有房屋所有人因不在房屋所在地或其他原因不能管理其房屋时,可以在房屋所在地委托代理人代为管理。委托代管应由本人出具委托书。
六、办理房屋所有权登记或转移、变更登记和委托手续的证件、文书,须经公证。在外国办理的公证文书,须经该国外交部或其委托的机构和中国驻该国大使馆、领事馆认证。
办理房屋所有权登记或转移、变更登记和委托手续的证件、文书,必须是正本。如果证件、文书是用外国文字书写的,须同时附交经公证和认证的中文译本。
七、本规定不适用于中外合资经营企业、中外合作经营企业和外资企业所有的房屋。
八、本规定自发布之日起施行。

PROVISIONS CONCERNING THE ADMINISTRATION OF PRIVATE HOUSES OWNEDBY FOREIGNERS

Important Notice: (注意事项)
英文本源自中华人民共和国务院法制局编译, 中国法制出版社出版的《中华人民
共和国涉外法规汇编》(1991年7月版).
当发生歧意时, 应以法律法规颁布单位发布的中文原文为准.
This English document is coming from the "LAWS AND REGULATIONS OF THE
PEOPLE'S REPUBLIC OF CHINA GOVERNING FOREIGN-RELATED MATTERS" (1991.7)
which is compiled by the Brueau of Legislative Affairs of the State
Council of the People's Republic of China, and is published by the China
Legal System Publishing House.
In case of discrepancy, the original version in Chinese shall prevail.

Whole Document (法规全文)
PROVISIONS CONCERNING THE ADMINISTRATION OF PRIVATE HOUSES OWNED
BY FOREIGNERS
(Approved by the State Council on August 2, 1984 and promulgated
by the Ministry of Urban and Rural Construction and Environmental
Protection on August 25, 1984)
In order to strengthen the administration of private houses owned by
foreigners within the territory of China, and to protect the lawful rights
and interests of their owners, the following provisions are formulated in
accordance with the relevant laws and regulations:
1. The administration of the residential houses and nonresidential houses
owned by foreign individuals or by a group of foreigners jointly within
the territory of China and for their own use or for renting out
(hereinafter referred to as foreigners' private houses), shall comply with
the provisions in the Regulations on the Administration of Private Houses
in Urban Areas.
2. The owners of foreigners' private houses must go through the
registration procedures for the proprietary rights of houses at the
administrative departments for real estate under the people's governments
in the localities where the aforesaid houses are located (hereinafter
referred to as the administrative department for real estate), and after
the examination and verification, obtain a house owner's certificate; in
the event that the ownership of a house is to be transferred, the present
state of the houses is to be changed, or the owner's nationality has been
changed, the house owner must go through the registration procedures for
the transfer of the ownership, or for other changes, at the administrative
department for real estate in the place where the said house is located.
3. In going through the procedures for the registration of the ownership
of foreigners' private houses, of the transfer or changes, the owners of
the houses shall present certificates of nationality and occupation, as
well as the following certifying papers:
(1) with respect to newly-built, rebuilt, or expanded houses, the
construction licences approved by the planning and administrative
departments in the localities, and also the building blueprints;
(2) with respect to newly-bought houses, the original certificates of
title, the contracts for house transaction, and the title deeds of the
houses must be submitted;
(3) with respect to houses accepted as gifts, the original certificates of
title, the deeds of gift or deeds of demised house, and the title deeds of
the houses must be submitted;
(4) with respect to houses exchanged, the certificates of title of both
parties, the agreements signed by both parties, and the title deeds of the
houses must be submitted;
(5) with respect to inherited houses, the original certificates of title,
certifying documents for the inheritance, and the deeds of houses must be
submitted;
(6) with respect to houses allotted from one's family properties, the
original certificates of title, lists of the said allotment, and the deeds
of the houses must be submitted;
(7) with respect to houses the demolition of which, has been approved, the
original certificates of title, and the permission of demolition of the
houses must be submitted. If the aforesaid certifying documents are
incomplete or the ownership of the houses in question is uncertain, the
registration procedures shall be postponed until conditions are ripe for
registration.
4. When foreigners' private houses are rented or lent out, the relevant
lease contracts and the lending documents shall be presented, for the
record, to the administrative departments for real estate in the places
where the said houses are located.
5. If the owners of foreigners' private houses are unable to go through,
personally, the registration procedures for the transfer of ownership or
for other changes of the said houses, they may appoint agents or Chinese
attorneys at law to handle the case; and the owners of the houses shall
personally vest their agents or attorneys with powers of attorney.
If the owners of foreigners' private houses are unable to manage affairs
concerning their houses because of their absence from the places where
their houses are located, or owing to other reasons, they may appoint
agents residing in the places where the said houses are located to manage
the houses for them. The owners of the houses shall personally vest their
agents or attorneys with powers of attorney.
6. The certifying documents and title deeds to be used for going through
the registration procedures for the ownership of houses or for the
transfer of ownership or other changes and the appointment of agents,
shall be notarized. The notarial documents prepared and signed in a
foreign country shall be verified and confirmed by the Ministry of Foreign
Affairs of the said country, or by its authorized agencies, and by the
Chinese embassies or consulates in the said countries.
The certifying documents and title deeds to be used for going through the
registration procedures for the ownership of the houses or for the
transfer of ownership or for the other changes and the appointment of
agents, must be the original documents. If the certifying documents and
title deeds are prepared in foreign language, notarized and verified
translations in the Chinese language must be attached thereto.
7. These Provisions shall not apply to the houses owned by Chinese-foreign
equity joint ventures, Chinese-foreign contractual ventures, and
foreign-capital enterprises.
8. These Provisions shall go into effect as of the date of promulgation.


关于做好上市公司年报披露后风险防范工作的通知

中国证券监督管理委员会


关于做好上市公司年报披露后风险防范工作的通知

1999年5月31日 证监公司字[1999]24号


天津、沈阳、上海、广州、深圳、成都、重庆证券监管办公室(直属办),石家庄、哈尔滨、南京、郑州、海口、昆明证券监管特派员办事处:

  为了防范和化解1998年上市公司年报可能引发的证券市场风险,积极维护社会稳定,现将有关事项通知如下:

  一、要及时将辖区内上市公司在年报中反映出来的突出问题向省、市政府汇报

  截至1999年4月30日,868家上市公司在规定时间内公布了年度报告。从目前已披露的年报看,大多数上市公司在东南亚金融危机和国内特大洪涝灾害的情况下,积极调整经营战略,改善内部管理,取得了较好的经营业绩。但由于1998年亏损的上市公司数量增加,甚至部分上市公司资不抵债,亏损数额巨大,不能持续经营,导致1998年上市公司经营业绩较1997年有所下降。特别是深深房、深建摩、深中华、深华宝、东方航空、白云山、郑百文和渤海化工8家公司亏损额均超过了5亿元;有12家公司财务报告被会计师事务所出具了无法表示意见的审计报告, 1家公司被出具否定意见的审计报告;海、云南、深圳等地区上市公司亏损面较大。这些问题的集中暴露,已成为证券市场的不稳定因素。有关证监会监管机构要针对辖区内上市公司存在的突出问题,以书面形式向所在地人民政府进行专题汇报。请各地政府从防范金融风险和维护社会稳定的大局出发,帮助和督促存在问题的上市公司限期

整改,扭转不利局面。

  二、要加强对高风险上市公司的跟踪监管,建立重大突发事件请示报告制度

  针对今年上市公司年报暴露的突出问题,有关证监会监管机构要对风险度较高的的上市公司进行跟踪监管,及时发现问题,及时沟通信息,依法妥善处理。对可能引发证券市场风险的重大问题和突发性事件,要有预见性,做到防微杜渐,防患于未然;对可能影响股市和社会稳定的问题,要及时掌握情况,积极研究紧急处置预案,迅速向地方政府和中国证监会报告。

  三、指导上市公司依法召开股东大会,积极配合地方政府,切实做好维护社会稳定工作

  近期,上市公司召开年度股东大会比较集中,有关证监会监管机构要针对辖区内上市公司的情况,加强对上市公司股东大会的监督指导,努力消除不安定因素,防止在股东大会上出现矛盾激化的情况,影响社会稳定。

  四、各有关证监会监管机构应在6月28日前将落实本通知要求的情况,以书面形式向中国证监会上市公司监管部报告。

  联 系 人:安青松 顾 群

  联系电话:010-88061146

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