您的位置: 首页 » 法律资料网 » 法律法规 »

对外经济贸易部、国家工商行政管理局关于承包经营中外合资经营企业的规定(附英文)

时间:2024-07-25 19:51:58 来源: 法律资料网 作者:法律资料网 阅读:8678
下载地址: 点击此处下载

对外经济贸易部、国家工商行政管理局关于承包经营中外合资经营企业的规定(附英文)

对外贸易经济合作部 国家工商局


对外经济贸易部、国家工商行政管理局关于承包经营中外合资经营企业的规定(附英文)

1990年9月13日,对外经济贸易部、国家工商局

为了促进中外合资经营企业(以下简称“合营企业”)的正常发展,现对承包经营合营企业做如下规定:
一、承包经营的定义
本规定内所述承包经营是指合营企业与承包者通过订立承包经营合同,将合营企业的全部或部分经营管理权在一定期限内交给承包者,由承包者对合营企业进行经营管理。承包经营只是解决部分合营企业经营管理不善、严重亏损的补充措施。在承包经营期内,由承包者承担经营风险并获取部分合营企业的收益。
二、合营企业实行承包经营的条件
合营企业必须符合下列全部条件方可实行承包经营:
1、合营企业应是属于国家鼓励或允许的行业的项目。但属于国家重点项目,特别是能源和交通项目,不得实行承包经营。
2、中外合营者已经按合营合同如期如数出资并经过验资,确因经营管理不善而难以维持的合营企业。
三、承包者的资格
承包者应具备以下资格:
1、具备法人资格并已有3年以上经营活动的中国或外国的公司、企业;
2、与实行承包经营的合营企业属同类行业,并能提出切实解决该企业严重亏损及正常发展的具体方案;
3、能够向合营企业提供足够数额的风险抵押金或风险保证金保函。
四、承包经营的基本要求
1、承包经营可以采取公开招标方式确定承包者(即,董事会根据事先拟定的条件由合营企业公开招标);也可以根据董事会决议由合营企业直接与承包者(可以是合营一方,也可以是第三方)签订承包经营协议。
2、承包经营不得改变合营企业的法人地位、名称和经营范围。
3、承包者是合营企业财产的经营管理者,应严格执行承包经营合同,接受合营企业董事会的监督。承包者对合营企业的财产无权行使任何形式的处置权,如,转让、变卖、转移、抵押、出租、赠送等。承包者应定期据实向合营企业董事会报送企业的财务报表。
4、承包经营期限一般为1至3年,最长不得超过5年。承包者应保证,承包经营期满时,合营企业能够扭亏为盈或经营状况有明显改善。
5、承包经营只能对合营企业的税后利润实行承包。承包双方应根据设立合营企业时的可行性报告中的有关指标及市场的实际情况确定承包期间的年利润基数。
6、承包经营期内,承包者须于每年第一季度内向合营企业提交承包经营风险保证金保函或风险抵押金。抵押金不得再另设担保,不得以合营者的出资作抵押。风险保证金、保函须以银行不可撤销、合营企业可以单方提款的形式提供。无论以哪种形式,其数额均不得低于当年承包利润总额的50%。
7、承包经营期间,承包者若以合营企业的名义贷款,须经董事会同意。承包经营期间,合营企业的负债余额不得超过当年承包利润的总额。
8、承包经营期间,合营企业仍应执行国家各项法律、法规和财务会计制度。
承包者所得承包收入应依法缴纳所得税。
承包经营的财务、会计、税务按财政税务部门的有关规定办理。
9、连续两年未按合同规定完成承包利润额的,除按合同规定,每年度结束后,合营企业收缴承包者的风险抵押金或按银行保函提取风险保证金,或按承包合同规定的赔偿额赔偿合营企业外,原审批机关可撤销对承包合同的批准,承包合同失效,承包关系自行解除,工商行政管理机关收缴承包经营登记证件,并办理合营企业的相应变更登记。
解除承包经营合同后,合营企业仍无法扭转严重亏损的,应依法律和合营合同的规定解散合营企业。
10、承包经营开始前,承包经营期内中止以及承包期满时,合营企业应进行清产核资,做好移交工作。清产核资应有中国注册会计师的验证方为有效。
五、承包合同
1、承包经营合营企业,必须由合营企业与承包者签订承包经营合同。不允许合营企业投资各方之间签订承包利润的合同。
2、承包合同应依照中国的有关法律订立,并应符合原合营企业合同的宗旨和原则,不得修改合营企业合同中与承包经营无关的条款。
3、承包经营合同中必须包括载有承包经营期限,承包者的权利和权限、义务和责任,承包经营的方式和内容,承包经营收益的分配方式,承包经营风险保证金、保函或风险抵押金,违约罚则,承包经营合同争议的解决方式,对承包经营前合营企业的亏损和/或债务的责任,清产核资的原则和移交程序、计价办法,承包的生产指标和利润额,技术更新指标,企业债务安全线,承包后对合营企业原有人员的安排、劳动管理、工资、福利、保险,以及在承包经营期内因执行承包合同而同其他公司、企业、个人等引起的纠纷由谁负责处理和承担责任等内容。
4、承包期间,承包者严重违反合同的,合营企业的董事会有权解除合同并要求承包者给以相应的经济补偿。
5、承包经营合同及其变更、延期、中止、终止均须经合营企业原审批机关批准。
六、承包经营的申请、审批与登记
1、申请承包经营,须由合营企业向原审批机关提出申请并报送下列文件:
(1)合营企业实行承包经营的申请报告;
(2)合营企业董事会关于实行承包经营的决议;
(3)经合营企业董事会批准的,由承包者提出的使企业扭亏为盈的具体措施的报告;
(4)承包者的合法开业证明、公司章程及最近3年的资产负债表;
(5)承包经营合同;
(6)原合营企业合同及可行性研究报告;
(7)主管部门、财政税务部门对该合营企业承包经营的意见;
(8)审批机关需要的其他有关文件。
2、审批机关自接到全部文件起30天内,根据本规定决定批准或者不批准。审批机关对承包经营合同中不合法或显属不公平之处,得要求限期修改,否则不予批准。
3、自审批机关发给合营企业批准承包经营的文件之日起30日内,持已交纳风险抵押金或风险保证金保函的证明到工商行政管理机关办理登记手续。30日内未办理工商登记手续,审批机关的批准自动失效。工商行政管理机关应自受理申请后30日内予以登记。
自工商行政管理机关签发登记证件之日起,计算承包经营期限。
承包经营的开业、变更、注销登记手续按工商行政管理机关的规定办理。
七、其他
1、现已实行承包经营的合资企业,应在本规定公布之日起90日内,补办承包经营的审批登记手续。已签订的承包经营合同,可参照本规定进行修订。逾期不补办审批登记手续的,审批机关和工商行政管理机关可联合责令合营企业和承包者停止承包经营合同,直至收缴合营企业执照,冻结承包者的利润,并由工商行政管理机关对合营企业和承包者予以处罚。
2、今后凡实行承包经营的合营企业及承包者隐瞒真实情况,不申请办理审批登记手续的,一经发现,审批机关和工商行政管理机关将依法对合营企业及承包者予以处罚。
3、中外合营企业委托外国企业经营管理的,仍执行国家工商行政管理局和对外经济贸易部于1988年6月11日发布的工商企字[1988]第98号《关于委托经营管理合营企业的外国(地区)企业审批登记问题的通知》。
4、中外合作经营企业的承包经营参照本规定办理。
5、本规定自公布之日起实施。

REGULATIONS FOR CONTRACTED OPERATION OF CHINESE-FOREIGN EQUITYJOINT VENTURES

(Promulgated on October 15, 1990)

Whole Doc.
The following regulations on contracted operation of Chinese-foreign
equity joint ventures (hereinafter referred to as joint ventures) are
aimed at guaranteeing the normal development of these enterprises.

Article 1 Definition of contracted operation
The contracted operation mentioned in these regulations is meant for
joint ventures which, by signing contracts, offer the whole or part of
their operational rights to contractors for a certain period of time while
those joint ventures are managed by the contractors. Such forms of
contracted operation are but supplementary measures to help those poorly
managed and loss-making joint ventures. During the contracting term, the
contractor takes on the risks of operation while gaining part of the joint
venture's profits.

Article 2 Requirements for contracted operation of joint ventures
A joint venture shall fulfill the following requirements to practice
contracted operation:
(1) That it is a project in an industry encouraged or permitted by
State policy. However, key state projects, those in energy or
communications in particular, shall not practice contracted operation.
(2) That the Chinese and foreign partners of the joint venture have
fully provided the investment required by contract and the payment has
been verified-but the joint venture is hardly likely to survive because of
poor management.

Article 3 Contractors' qualifications
A contractor must have the following qualifications:
(1) That it is a Chinese or foreign corporation or enterprise with
the qualification of a legal person, and has engaged in business operation
for at least 3 years;
(2) That is belongs to the same industry as the joint venture and can
work out a concrete plan to effectively help the business make up deficits
and return to normal development; and
(3) That it is able to provide adequate risk deposit and a
letter-of-guarantee for the risk-guaranty money.

Article 4 Basic requirements for contracted operation
(1) The contractor can be chosen through public bidding (i.e., the
joint venture conducts public bidding in accordance with the conditions
worked out by the board of directors); alternatively, the joint venture
can sign directly an agreement on contracted operation with the contractor
(either partner of the venture or a third party) in accordance with the
decision made by the board of directors.
(2) The legal-person status, name and business scope of the joint
venture shall not be changed because of contracted operation.
(3) As the operator and manager of the joint venture's property, the
contractor shall strictly carry out the contract and be under the
supervision of the venture's board of directors. The contractor has no
right to dispose of the joint venture's property, such as transfer,
selling off, removing, mortgaging, leasing or giving out as a present. The
contractor shall regularly submit factual financial reports to the joint
venture's board of directors.
(4) The contracting term is usually set at 1 to 3 years. The maximum
shall be no more than 5 years. The contractor shall see to it that the
joint venture becomes profitable or at least its performance is improved
remarkably when the contracting term expires.
(5) Contracting shall only cover the joint venture's after-tax
profits. Both parties to such contracts shall decide on the annual profit
during the contracting term base in accordance with relevant targets
defined in the feasibility study report worked out when the joint venture
was launched.
(6) During the contractual term the contractor shall, in the first
quarter of each year, submit to the joint venture risk guaranty money,
letter of guarantee or risk deposit. No securities shall be made for the
deposit, which shall not come from the investment by the joint venture's
partners. The risk guaranty money and the letter of guarantee shall be
irrevocable and unilaterally drawable to the joint venture. Whatever the
form the sum shall be not less than 50 percent of the contracted annual
profit.
(7) During the contracting term the contractor shall get approval
from the board of directors before applying for any loan in the name of
the joint venture. The debt of the joint venture during the contracting
term shall not exceed the total amount of the contracted profit for the
year.
(8) During the contracting term, the joint venture shall continue to
implement State laws, regulations and accounting rules.
In accordance with law, the contractor shall pay income tax on its
earnings from contracting.
The financial, accounting and tax affairs related to the contracted
operation shall be handled in accordance with relevant regulations adopted
by the financial and taxation departments.
(9) If the contractor fails, for two years in succession, to fulfill
contracted-profit obligations, besides the joint venture shall, at the end
of a fiscal year, take over the contractor's risk deposit or draw the risk
guaranty money according to the bank's letter of guarantee, or the
contractor shall pay for the loss according to contract, the examination
and approval authority may annual the approval. Consequently, the contract
shall cease to be in force, the contractual relationship shall
automatically be renounced, while the administration for industry and
commerce shall recall the certificate of registration for the contracted
operation and register the changed operational status of the joint
venture.
The joint venture shall be dissolved according to the law and the
joint venture contract if, after the contracted operation has ceased, the
venture still fails to change its loss-making situation.
(10) Before the contracted operation, and when the contracted
operation is terminated during the contracting term or when the
contracting term expires, the joint venture shall make an inventory of
property and capital and transfer management from one to another. The
inventory is valid only when it has been certified by accountants
registered in China.

Article 5 Contract on contracted operation
(1) To contract the operation of a joint venture, the contractor
shall sign a contract with the joint venture. Contracts on contracting
profit between partners of the venture are not permitted to sign.
(2) The contract shall be concluded in accordance with relevant
Chinese laws, in keeping with the purposes and principles of the original
contract of the joint venture and without changing the items of the
original contract that have nothing to do with the contracted operation.
(3) The contract shall include the contracting term, the rights and
restrictions on the rights, and duties and responsibilities of the
contractor, the form and content of the contracted operation, the
distribution pattern of income, risk guaranty money, letter of guarantee
and risk deposit, liability for breach of contract, ways to settle
disputes over contract, responsibilities on losses and/or debt owed by the
joint venture prior to the contracted operation, the principles of making
an inventory of property and capital and the transferring procedures as
well as the method of evaluating, production targets and profit, target
for technological upgrading, the debt safety line, the arrangements for
the workers of the joint venture, labour management, wages, welfare and
insurance, and the party which shall handle and be responsible for the
disputes with other corporations, enterprises and individuals in the
course of implementing the contract on contracted operation.
(4) If the contractor severely violates the contract during the
contracting term, the joint venture's board of directors has the right to
terminate the contract and demand corresponding compensation for loss from
the contractor.
(5) The revision, postponement, termination or expiration of the
contract shall be approved by the original authorities that approved the
joint venture.

Article 6 Application, examination and approval and registration of contracted operation
(1) The joint venture shall apply for contracted operation and submit
the following documents to the examination and approval authority:
((1)) An application on contracted operation of the joint venture;
((2)) The decision of the joint venture's board of directors on
contracted operation;
((3)) A report containing concrete measures to turn the joint venture
from loss-making to profitable, measures worked out by the contractor and
approved by the joint venture's board of directors:
((4)) The contractor's legal business license, articles of
association of the corporation, and a balance sheet covering the past 3
years operations;
((5)) The contract on contracted operation;
((6)) The original contract of the joint venture and report on
feasibility stu dies;
((7)) Opinions of the government department in charge and financial
and taxati on departments on contracted operation of the joint venture;
and
((8)) Other documents required by the examination and approval
authority.
(2) The examination and approval authority, within 30 days of
receiving all th e above-mentioned documents, shall decide to approve or
not approve the contracted operation in accordance with these regulations.
The authority shall, within a specified time, demand revision of illegal
or obviously unfair contents in the contract. Otherwise the application
shall not be approved.
(3) Within 30 days from the date when the examination and approval
authority issued documents of approval for the contracted operation, the
contractual parties shall, with the certificate on the delivery of risk
deposit or letter of guarantee and risk guaranty money, go through the
formalities of registration with the administration for industry and
commerce. The approval of the examination and approval authority shall
automatically cease to be effective if registration is not done in 30
days. The administration for industry and commerce shall handle
registration within 30 days of receiving the application.
The term of contracted operation begins from the date on which the
administration for industry and commerce issues registration documents.
The registration of the opening and alteration of contracted
operation and cancellation of registration shall be handled in accordance
with the regulations of the administration for industry and commerce.

Article 7 Supplementary rules
(1) Joint ventures which are already under contracted operation must,
within 90 days from the date these regulations are published,
retroactively go through procedures of the examination and approval and
registration for contractual operation. Contracts already concluded may be
revised by referring to these regulations. The joint ventures and
contractors who fail to retroact formalities within the time, may be
ordered jointly by the examination and approval authority and the
administration for industry and commerce to terminate their contract, and
even their business license of the joint venture may be taken over and the
contractor's profit may be frozen.
(2) The examination and approval authority and administration for
industry and commerce may penalize joint ventures and contractors who
conceal their contracted operations without applying for approval and
going through the registration formalities.
(3) The circular on the examination, approval and registration of
enterprises from foreign countries or regions entrusted to manage
Chinese-foreign joint ventures, published on July 11, 1988 by the State
Administration for Industry and Commerce and the Ministry of Foreign
Economic Relations and Trade is still valid for those joint ventures which
entrust foreign enterprises with management and administration.
(4) Contracted operators of Chinese-foreign contractual joint
ventures may refer to these regulations.
(5) These regulations goes into effect on the day of promulgation.



辽宁省人民政府关于修订废止部分省政府规章的决定

辽宁省人民政府


辽宁省人民政府令

第130号


  《辽宁省人民政府关于修订废止部分省政府规章的决定》业经2001年12月18日辽宁省第九届人民政府第94次常务会议通过,现予公布,自公布之日起施行。

                   省 长
                 二○○一年十二月二十八日

辽宁省人民政府关于修订废止部分省政府规章的决定

为了适应我国加入世界贸易组织的需要,根据《中共中央办公厅、国务院办公厅关于适应我国加入世界贸易组织进程清理地方性法规、地方政府规章和其他政策措施的意见》(中办发〔2001〕22号)的要求,经过清理,省政府决定,修订《辽宁省流动人口计划生育管理实施办法》等6件省政府规章(见附件1),废止《辽宁省外商投资企业用地管理暂行办法》等21件省政府规章(见附件2)。
  附件1:辽宁省人民政府决定修订的部分规章(6件)
  附件2:辽宁省人民政府决定废止的规章目录(21件)


附件1:


辽宁省人民政府决定修订的部分规章(6件)

一、辽宁省流动人口计划生育管理实施办法
1.第八条修改为:流动人口必须在到现居住地3日内向当地的乡人民政府或者街道办事处交验婚育证明,签订计划生育合同;取得查验证明后,再到有关部门办理暂住证、营业执照等证件。
2.第十条修改为:有关部门在审批流动人口暂住证、营业执照等证件时,应当检查其现居住地的乡人民政府或者街道办事处出具的查验证明,并将审批结果通报其现居住地的乡人民政府或者街道办事处;对没有计划生育查验证明的,不得为其办理暂住证、营业执照等证件。
3.第二十三条修改为:公安、工商行政管理、卫生、建设、房产管理等部门人员审批流动人口有关证件时,不检查婚育查验证明或者明知无查验证明而予以批准的,由所在单位给予直接责任人行政处分,并由本级人民政府给予负有领导责任的单位负责人行政处分。
二、辽宁省流动人口治安管理办法
第二条修改为:本办法适用于离开常住户口所在地的县(含县级市),到其他地区暂住的人员。
出差、探亲、访友、旅游、就医人员不适用本办法。
三、辽宁省农业植物检疫实施办法
1.将第二条修改为:省农业行政管理部门是全省农业植物检疫工作的主管部门,其执行机构是省植物检疫机构;市、县(含县级市、区)农业行政管理部门主管本辖区的农业植物检疫工作,其执行机构是所属的植物检疫机构。
2.将第六条中的“省农牧业厅”修改为“省农业行政管理部门”。
3.将第七条修改为:凡农作物种子(含牧草种子)、果树苗木(下称苗木)和其他繁殖材料以及应检植物、植物产品,在调运之前,都要进行检疫。以商品粮、薯类改做种子用时,要严格检疫。
4.将第八条、第十二条中的“省植物保护站”修改为:“省植物检疫机构”。
四、辽宁省高新技术产业开发区管理暂行办法
1.删除第十五条,即:本条例所称高新技术企业是指利用高新技术生产高新产品,提供高新技术劳务的企业。
2.删除第十六条,即:符合下列各项条件的企业,可以认定为高新技术企业:
(一)从事一定范围内一种或者多种高新技术及其产品的研究、开发、生产和经营(单纯的商业性经营除外)业务;
(二)实行独立核算、自主经营、自负盈亏;
(三)有明确的企业章程和严格的技术财务管理制度;
(四)企业负责人熟悉本企业产品研究开发和生产经营,并且是本企业的专业人员;
(五)具有大专以上学历的科技人员占企业职工总数30%以上,从事高新技术及其产品研究、开发的科技人员占企业职工总数的10%以上,从事高新技术产品生产或服务的劳动密集型高新技术企业,具有大专以上学历的科技人员不少于职工总数的20%;
(六)有与其业务规模相适应的资金、经营场所和设施;
(七)企业每年用于高新技术产品研究、开发经费占本企业当年总收入的10%以上;
(八)技术性收入与高新技术产品销售收入的总和应占企业当年总收入的60%以上;
(九)企业的全员劳动生产率、人均利税率达到全国同行业的先进水平,“三废”的排放量及噪音等环保指标符合国家规定标准;
(十)企业的经营期能达到10年以上。
3.删除第十七条,即:申请认定高新技术企业,应填写《辽宁省高新技术企业认定审批表》,向开发区管委会提出申请,报省科技行政部门审批。
省科技行政部门应在收到申请之日起,30日内予以答复。
计划单列市所属开发区高新技术企业的认定,按本市人民政府规定执行。
4.删除第十八条,即:高新技术企业凭批准认定证书,享受国家和省规定的优惠政策。
5.删除第十九条,即:高新技术企业变更经营范围或合并、分立涉及高新技术企业认定条件的,须按规定程序重新办理认定手续。
6.删除第二十条,即:经营期未满10年的企业终止经营时,应在清理债权债务和财产之前,补交已减免的税款。
7.增加一条,作为第三十四条:高新技术企业的认定、审批及有关政策,按照国家和省的规定执行。
此外,对条文顺序作相应调整。
五、辽宁省工程勘察设计市场管理规定
第十六条修改为:国外和港、澳、台地区的工程勘察设计单位来我省承揽工程勘察设计项目,按照国家有关规定执行。
六、辽宁省公路养路费征收办法
删除第七条,即:对外国籍和台湾、香港、澳门地区籍的车辆,按国家或省人民政府认定的双边协议计征。没有双连协议的每月按费额标准的2倍计征。
此外,对条文顺序作相应调整。


附件2:



辽宁省人民政府决定废止的规章目录(21件)

  1.辽宁省外商投资企业用地管理暂行办法
   1989年1月19日发布辽政发〔1989〕7号文件发布
  2.辽宁省无线电管理暂行规定
   1987年8月24日发布辽政发〔1987〕106号文件发布
  3.辽宁省流动人口管理费征收使用管理办法
   1997年6月2日发布省政府第78号令发布
  4.辽宁省酒类专卖管理暂行办法
   1978年9月10日发布辽革发〔1978〕246号文件发布
  5.关于商业服务业网点建设与管理的若干规定
   1980年12月25日发布辽政发〔1980〕487号文件发布
  6.辽宁省市内电话用户集资暂行办法
   1985年7月30日发布辽政发〔1985〕98号文件发布
  7.辽宁省农业标准化管理暂行办法
   1986年10月3日发布,1997年12月26日修订
   辽政发〔1986〕110号文件发布,省政府第87号令修订
  8.关于加强工业企业环境管理的规定
   1987年8月17日发布辽政发〔1987〕100号文件批转
  9.辽宁省城市环境噪声管理暂行规定
   1988年7月6日发布辽政发〔1988〕55号文件发布
  10.辽宁省林地栽参管理暂行办法
   1989年8月10日发布辽政发〔1989〕73号文件
  11.辽宁省乡镇集体和个体开采矿产资源监督管理办法
   1991年4月26日发布省政府第6号令发布
  12.辽宁省出口商品质量监督管理暂行办法
   1992年12月26日发布,1997年12月26日修订
   辽政办发〔1992〕71号文件发布,省政府第87号令修订
  13.辽宁省全民所有制工业企业转换经营机制实施办法
   1993年3月11日发布省政府第31号令发布
  14.辽宁省粮食作物杂交种子专营办法
   1996年4月9日发布省政府第65号令发布
  15.辽宁省乡镇企业消防管理暂行规定
   1987年5月8日发布,1997年12月26日修订
   辽政发〔1987〕48号发布,省政府第87号令修订
  16.辽宁省金融机构安全防范规定
   1993年1月9日发布,1997年12月26日修订
   辽政办发〔1993〕5号发布,省政府第87号令修订
  17.辽宁省民用爆炸物品管理处罚规定
   1987年7月9日发布,1997年12月26日修订
   辽政发〔1987〕72号发布,省政府第87号令修订
  18.辽宁省国营企业招用工人实施细则
   1986年10月21日发布辽政发〔1986〕115号发布
  19.辽宁省国营企业辞退违纪职工实施细则
   1986年10月21日发布辽政发〔1986〕115号发布
  20.辽宁省野生药材资源保护管理实施细则
   1988年12月26日发布辽政发〔1988〕101号发布
  21.辽宁省麻醉药品管理办法

   1992年11月20日发布


医疗器械企业产品标准化工作规定

国家医药管理局


医疗器械企业产品标准化工作规定
1996年3月11日,医药管理局

一、为规范医疗器械企业产品标准化工作,依据标准化法律、法规、医药标准化管理办法,以及医疗器械产品分类分级管理的原则,对医疗器械企业产品标准化工作做出规定。
二、企业(生产者)生产医疗器械产品必须承担保障使用者安全的责任,其产品必须有相应的产品标准。医疗器械行政监督管理部门必须严格执行没有产品标准不能组织生产、没有产品标准的医疗器械品种不准进入市场销售的原则,进入市场者视同伪劣产品。
三、医疗器械产品有国家标准或行业标准的,医疗器械行政监督管理部门应鼓励企业制定严于国家标准或行业标准的企业产品标准。
四、医疗器械行政监督管理部门对医疗器械企业产品标准化工作进行监督管理;企业产品标准由企业制定,企业法人或企业法人委托的组织机构对产品标准应组织有标准化技术归口、生产、临床、科研等方面专家参加的标准技术审查,参加技术审查的专家应对产品标准的审查负责。
五、医疗器械企业产品标准技术审查应以产品接触人体的方式、类型、材料、技术结构,重点审查标准中以电气安全、生物安全、化学安全、机械安全、物理安全等方面确定的技术要求,并形成参与审查专家的确认意见。
六、企业(生产者)在制定产品标准中,涉及产品安全性能要求的,若目前无相应国家、行业标准时,应首先考虑等同采用相关的国际标准或国外先进标准;无相关的国际标准和国外先进标准时,其安全性要求企业应自行制定,并应按本规定四、五、条进行产品标准技术审查。
七、医疗器械行政监督管理部门对医疗器械企业产品标准是否执行国家、行业标准及采用相关国际标准和国外先进标准情况进行监督;标准化技术归口单位在参加企业产品标准技术审查时,应对实施国家、行业标准和采标情况明确提出意见,国家医疗器械行政监督管理部门对技术归口单位的意见有责任予以确认。
八、医疗器械企业产品标准备案部门和医疗器械产品市场准入审查部门发现备案的企业产品标准违反有关法律、法规和强制性标准时,应责令申报备案的企业限期改正或停止实施。
九、第三方检测机构在执行现行国家、行业标准对产品进行检测时,若发现某些项目不具备检测手段,应按有关规定实施委托检测;若委托检测也不能进行时,应向国家医疗器械行政监督主管部门提出处理意见,由国家医疗器械行政监督管理部门确定后公布执行。
十、国家、行业级医疗器械产品质量检验机构,在执行备案后的企业产品标准检测中,对标准中不符合安全性要求的方面应在检测报告中注明,并可提交医疗器械行政监督管理部门处理,对备案后的企业产品标准检测不能拒绝和拖延。
十一、自1996年1月1日起所有医疗器械报批标准都应符合GB/T1.1-1993《标准化工作导则 第1单元 标准的起草与表述规则 第1部分 标准编写的基本规定》国家标准要求。各级医疗器械行政监督管理部门应进行监督严格按要求执行,不符合要求者,不予受理。
十二、本规定自发布之日起实施。