国务院


中华人民共和国海洋石油勘探开发环境保护管理条例(附英文)

1983年12月29日，国务院

第一条 为实施《中华人民共和国海洋环境保护法》，防止海洋石油勘探开发对海洋环境的污染损害，特制定本条例。
第二条 本条例适用于在中华人民共和国管辖海域从事石油勘探开发的企业、事业单位、作业者和个人，以及他们所使用的固定式和移动式平台及其他有关设施。
第三条 海洋石油勘探开发环境保护管理的主管部门是中华人民共和国国家海洋局及其派出机构，以下称“主管部门”。
第四条 企业或作业者在编制油（气）田总体开发方案的同时，必须编制海洋环境影响报告书，报中华人民共和国城乡建设环境保护部。城乡建设环境保护部会同国家海洋局和石油工业部，按照国家基本建设项目环境保护管理的规定组织审批。
第五条 海洋环境影响报告书应包括以下内容：
（一）油田名称、地理位置、规模；
（二）油田所处海域的自然环境和海洋资源状况；
（三）油田开发中需要排放的废弃物种类、成分、数量、处理方式；
（四）对海洋环境影响的评价；海洋石油开发对周围海域自然环境、海洋资源可能产生的影响；对海洋渔业、航运、其他海上活动可能产生的影响；为避免、减轻各种有害影响，拟采取的环境保护措施；
（五）最终不可避免的影响、影响程度及原因；
（六）防范重大油污染事故的措施：防范组织，人员配备，技术装备，通信联络等。
第六条 企业、事业单位、作业者应具备防治油污染事故的应急能力，制定应急计划，配备与其所从事的海洋石油勘探开发规模相适应的油收回设施和围油、消油器材。

配备化学消油剂，应将其牌号、成分报告主管部门核准。
第七条 固定式和移动式平台的防污设备的要求：
（一）应设置油水分离设备；
（二）采油平台应设置含油污水处理设备，该设备处理后的污水含油量应达到国家排放标准；
（三）应设置排油监控装置；
（四）应设置残油、废油回收设施；
（五）应设置垃圾粉碎设备；
（六）上述设备应经中华人民共和国船舶检验机关检验合格，并获得有效证书。
第八条 一九八三年三月一日以前，已经在中华人民共和国管辖海域从事石油勘探开发的固定式和移动式平台，防污设备达不到规定要求的，应采取有效措施，防止污染，并在本条例颁布后三年内使防污设备达到规定的要求。
第九条 企业、事业单位和作业者应具有有关污染损害民事责任保险或其他财务保证。
第十条 固定式和移动式平台应备有由主管部门批准格式的防污记录簿。
第十一条 固定式和移动式平台的含油污水，不得直接或稀释排放。经过处理后排放的污水，含油量必须符合国家有关含油污水排放标准。
第十二条 对其他废弃物的管理要求：
（一）残油、废油、油基泥浆、含油垃圾和其他有毒残液残渣，必须回收，不得排放或弃置入海；
（二）大量工业垃圾的弃置，按照海洋倾废的规定管理；零星工业垃圾，不得投弃于渔业水域和航道；
（三）生活垃圾，需要在距最近陆地十二海里以内投弃的，应经粉碎处理，粒径应小于二十五毫米。
第十三条 海洋石油勘探开发需要在重要渔业水域进行炸药爆破或其他对渔业资源有损害的作业时，应采取有效措施，避开主要经济鱼虾类的产卵、繁殖和捕捞季节，作业前报告主管部门，作业时并应有明显的标志、信号。
主管部门接到报告后，应及时将作业地点、时间等通告有关单位。
第十四条 海上储油设施、输油管线应符合防渗、防漏、防腐蚀的要求，并应经常检查，保持良好状态，防止发生漏油事故。
第十五条 海上试油应使油气通过燃烧器充分燃烧。对试油中落海的油类和油性混合物，应采取有效措施处理，并如实记录。
第十六条 企业、事业单位及作业者在作业中发生溢油、漏油等污染事故，应迅速采取围油、回收油的措施，控制、减轻和消除污染。
发生大量溢油、漏油和井喷等重大油污染事故，应立即报告主管部门，并采取有效措施，控制和消除油污染，接受主管部门的调查处理。
第十七条 化学消油剂要控制使用：
（一）在发生油污染事故时，应采取回收措施，对少量确实无法回收的油，准许使用少量的化学消油剂。
（二）一次性使用化学消油剂的数量（包括溶剂在内），应根据不同海域等情况，由主管部门另做具体规定。作业者应按规定向主管部门报告，经准许后方可使用。
（三）在海面浮油可能发生火灾或者严重危及人命和财产安全，又无法使用回收方法处理，而使用化学消油剂可以减轻污染和避免扩大事故后果的紧急情况下，使用化学消油剂的数量和报告程序可不受本条（二）项规定限制。但事后，应将事故情况和使用化学消油剂情况详细报告主管部门。
（四）必须使用经主管部门核准的化学消油剂。
第十八条 作业者应将下列情况详细地、如实地记载于平台防污记录簿：
（一）防污设备、设施的运行情况；
（二）含油污水处理和排放情况；
（三）其他废弃物的处理、排放和投弃情况；
（四）发生溢油、漏油、井喷等油污染事故及处理情况；
（五）进行爆破作业情况；
（六）使用化学消油剂的情况；
（七）主管部门规定的其他事项。
第十九条 企业和作业者在每季度末后十五日内，应按主管部门批准的格式，向主管部门综合报告该季度防污染情况及污染事故的情况。
固定式平台和移动式平台的位置，应及时通知主管部门。
第二十条 主管部门的公务人员或指派的人员，有权登临固定式和移动式平台以及其他有关设施，进行监测和检查。包括：
（一）采集各类样品；
（二）检查各项防污设备、设施和器材的装备、运行或使用情况；
（三）检查有关的文书、证件；
（四）检查防污记录簿及有关的操作记录，必要时可进行复制和摘录，并要求平台负责人签证该复制和摘录件为正确无误的副本；
（五）向有关人员调查污染事故；
（六）其他有关的事项。
第二十一条 主管部门的公务船舶应有明显标志。公务人员或指派的人员执行公务时，必须穿着公务制服，携带证件。
被检查者应为上述公务船舶、公务人员和指派人员提供方便，并如实提供材料，陈述情况。
第二十二条 受到海洋石油勘探开发污染损害，要求赔偿的单位和个人，应按照《中华人民共和国环境保护法》第三十二条的规定及《中华人民共和国海洋环境保护法》第四十二条的规定，申请主管部门处理，要求造成污染损害的一方赔偿损失。受损害一方应提交污染损害索赔报告书，报告书应包括以下内容：
（一）受石油勘探开发污染损害的时间、地点、范围、对象；
（二）受污染损害的损失清单，包括品名、数量、单价、计算方法，以及养殖或自然等情况；
（三）有关科研部门鉴定或公证机关对损害情况的签证；
（四）尽可能提供受污染损害的原始单证，有关情况的照片，其他有关索赔的证明单据、材料。
第二十三条 因清除海洋石油勘探开发污染物，需要索取清除污染物费用的单位和个人（有商业合同者除外），在申请主管部门处理时，应向主管部门提交索取清除费用报告书。该报告书应包括以下内容：
（一）清除污染物的时间、地点、对象；
（二）投入的人力、机具、船只、清除材料的数量、单价、计算方法；
（三）组织清除的管理费、交通费及其他有关费用；
（四）清除效果及情况；
（五）其他有关的证据和证明材料。
第二十四条 由于不可抗力发生污染损害事故的企业、事业单位、作业者，要求免于承担赔偿责任的，应向主管部门提交报告。该报告应能证实污染损害确实属于《中华人民共和国海洋环境保护法》第四十三条所列的情况之一，并经过及时采取合理措施仍不能避免的。
第二十五条 主管部门受理的海洋石油勘探开发污染损害赔偿责任和赔偿金额纠纷，在调查了解的基础上，可以进行调解处理。
当事人不愿调解或对主管部门的调解处理不服的，可以按《中华人民共国海洋环境保护法》第四十二条的规定办理。
第二十六条 主管部门对违反《中华人民共和国海洋环境保 护法》和本条例的企业、事业单位、作业者，可以责令其限期治理，支付消除污染费用，赔偿国家损失；超过标准排放污染物的，可以责令其交纳排污费。
第二十七条 主管部门对违反《中华人民共和国海洋环境保护法》和本条例的企业、事业单位、作业者和个人，可视其情节轻重，予以警告或罚款处分。
罚款分为以下几种：
（一）对造成海洋环境污染的企业、事业单位、作业者的罚款，最高额为人民币十万元。
（二）对企业、事业单位、作业者的下列违法行为，罚款最高额为人民币五千元：
1．不按规定向主管部门报告重大油污染事故；
2．不按规定使用化学消油剂。
（三）对企业、事业单位、作业者的下列违法行为，罚款最高额为人民币一千元：
1．不按规定配备防污记录簿；
2．防污记录簿的记载非正规化或者伪造；
3．不按规定报告或通知有关情况；
4．阻挠公务人员或指派人员执行公务。
（四）对有直接责任的个人，可根据情节轻重，酌情处以罚款。
第二十八条 当事人对主管部门的处罚决定不服的，按《中华人民共和国海洋环境保护法》第四十一条的规定处理。
第二十九条 主管部门对主动检举、揭发企业、事业单位、作业者匿报石油勘探开发污染损害事故，或者提供证据，或者采取措施减轻污染损害的单位和个人，给予表扬和奖励。
第三十条 本条例中下列用语的含义是：
（一）“固定式和移动式平台”，即《中华人民共和国海洋环境保护法》中所称的钻井船、钻井平台和采油平台，并包括其他平台。
（二）“海洋石油勘探开发”，是指海洋石油勘探、开发、生产储存和管线输送等作业活动。
（三）“作业者”，是指实施海洋石油勘探开发作业的实体。
第三十一条 本条例自发布之日起施行。

REGULATIONS OF THE PEOPLE'S REPUBLIC OF CHINA ON THE ADMINISTRA-TION OF ENVIRONMENTAL PROTECTION IN THE EXPLORATION AND DEVELOPMENT OFOFFSHORE PETROLEUM

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)
REGULATIONS OF THE PEOPLE'S REPUBLIC OF CHINA ON THE ADMINISTRA-
TION OF ENVIRONMENTAL PROTECTION IN THE EXPLORATION AND DEVELOPMENT OF
OFFSHORE PETROLEUM
(Promulgated by the State Council on December 29, 1983)
Article 1
These Regulations are formulated in order to implement the Marine
Environmental Protection Law of the People's Republic of China and prevent
pollution damage to marine environment resulting from offshore petroleum
exploration and development.
Article 2
These Regulations are applicable to enterprises, institutions, operators
and individuals engaged in the exploration and development of petroleum in
the sea areas under the jurisdiction of the People's Republic of China,
and the stationary and mobile platforms and other relevant facilities they
use.
Article 3
The departments in charge of environmental protection in exploration and
development of offshore petroleum are the State Oceanographic Bureau of
the People's Republic of China and its agencies, hereinafter referred to
as the "competent departments".
Article 4
Enterprises or operators, while compiling the overall programs for
developing oil (gas) fields, must compile a marine environmental impact
report and submit it to the Ministry of Urban and Rural Construction and
Environmental Protection of the People's Republic of China. The Ministry
of Urban and Rural Construction and Environmental Protection, in
conjunction with the State Oceanographic Bureau and the Ministry of
Petroleum Industry, is to organize examination and approval in accordance
with the stipulations governing the administration of environmental
protection over the projects of state capital construction.
Article 5
The marine environmental impact report shall include the following:
(1) the name, geographical position and size of the oil field;
(2) the natural environment and the conditions of marine resources of the
sea areas where the oil field is located;
(3) the types, composition, amount and the means of disposal of the waste
materials to be discharged in developing the oil field;
(4) an assessment of the impact on the marine environment; the possible
impact from development of offshore petroleum on the natural environmental
and marine resources of the surrounding sea areas; the possible impact on
the sea fishery, shipping and other sea activities; measures for
environmental protection to be adopted to avoid and reduce various types
of harmful impact;
(5) the impact that can not be avoided in the final outcome and the
graveness and causes of the impact;
(6) measures for preventing major oil pollution accidents: the
organization of prevention, provision of personnel, technical equipment
and communications and liaison.
Article 6
Enterprises, institutions and operators shall have the capacity of dealing
with emergencies with regard to the prevention and control of oil
pollution accidents, formulate emergency plans, have oil-recovery
facilities and equipment for containing oil and eliminating oil
commensurate with the scale of exploration and development of offshore
petroleum in which they are engaged.
If oil-eliminating chemical agents are to be used, their brand names and
composition shall be reported to the competent departments for
verification and approval.
Article 7
The requirements for the pollution-prevention equipment of the stationary
and mobile platforms are:
(1) oil and water separation equipment shall be fitted;
(2) the oil extraction platforms shall be fitted with the equipment for
treating oil-polluted water; the oil content of the polluted water, after
treatment by this equipment, shall reach the discharge standards set by
the State;
(3) devices for monitoring and control of oil discharge shall be fitted;
(4) facilities for retrieving residual oil and waste oil shall be fitted;
(5) equipment for garbage pulverization shall be fitted;
(6) the above equipment shall go through the examination by the shipping
inspection agencies of the People's Republic of China and must satisfy the
standards before efficacy certificates are issued.
Article 8
The stationary and mobile platforms that already started petroleum
exploration and development in the sea areas under the jurisdiction of the
People's Republic of China before March 1, 1983, if their pollution-
prevention equipment do not meet the stipulated requirements, shall adopt
effective measures to prevent pollution, and their pollution-prevention
facilities are to satisfy the stipulated requirements within three years
of the promulgation of these Regulations.
Article 9
The enterprises, institutions and operators shall possess civil liability
insurance or other financial guarantees to cover pollution damage.
Article 10
The stationary and mobile platforms shall be fitted with anti-pollution
record books in the format approved by the competent departments.
Article 11
The oil-polluted water of stationary and mobile platforms may not be
directly discharged or after dilution. The oil content of the oil-polluted
water discharged after treatment must meet the State's relevant standards
of discharging oil-polluted water.
Article 12
Requirements of control for other waste materials:
(1) residual oil, waste oil, oil-based mud, garbage containing oil and
other toxic residual liquid and dregs must be recovered, and may not be
discharged or cast off into the sea;
(2) the dumping of industrial garbage in large quantities is to be managed
in accordance with the stipulations of marine dumping of waste materials;
fragmentary industrial garbage may not be discarded into the fishery
waters and sea-lanes;
(3) domestic garbage that need to be discharged within 12 nautical miles
from the nearest land shall undergo pulverization treatment with the
granules less than 25 millimeters in diameter.
Article 13
Where exploration and development of offshore petroleum require explosive
demolitions by using explosives or other operations that are harmful to
fishery resources in the important fishery waters, effective measures
shall be adopted to avoid the spawning, breeding and fishing seasons of
the major fishes and shrimps of economic value; a report is to be made to
the competent departments before the operations and there shall be clear
signs and signals when the operations are under way.
The competent departments, on receiving the report, shall notify the
relevant units of the place and time of the operations in good time.
Article 14
Marine oil storage facilities and pipelines for the conveyance of oil
shall conform to anti-seepage, anti-leakage and anti-rotting requirements,
and shall constantly be checked and maintained in good condition, so as to
prevent oil leakage.
Article 15
In testing oil on the sea, oil and gas shall be fully burned out in the
combustion devices. With regard to the oils and oil-based mixtures falling
into the sea in the course of testing oil, effective measures shall be
adopted to treat them, and accurate records are to be kept.
Article 16
Enterprises, institutions and operators shall, immediately upon detection
of the occurrence of pollution accidents such as oil overflow and oil
leakage in operation, adopt measures for containing oil and oil recovery
to control, reduce and remove the pollution. In case of occurrence of
major pollution accidents such as oil overflow, oil leakage and well
blowout in large quantities, report shall immediately be made to the
competent departments, and effective measures are to be adopted to control
and remove the oil pollution, and the matter shall be subject to
investigation and handling by the competent departments.
Article 17
The use of oil-eliminating chemical agents shall be controlled:
(1) When oil pollution accidents occur, measures for recovery shall be
adopted; with regard to the small amount of oil that is actually beyond
recovery, it is permitted to use a small amount of oil-eliminating
chemical agents.
(2) With regard to the amount of irretrievable oil-eliminating chemical
agents (including the solvent) to be used, separate specific stipulations
shall be worked out by the competent departments according to different
conditions in different sea areas. The operators shall report to the
competent departments according to stipulations, and may only use these
chemical agents after approval has been obtained.
(3) In emergencies where oil floating on the surface of the sea may cause
fire or may gravely endanger human lives and property, and the matter is
unable to be handled with the method of recovery, but, by using oil-
eliminating chemical agents, pollution can be reduced and the consequences
of the accidents be contained, the amount of oil-eliminating chemical
agents used and the reporting procedures may go beyond the restrictions as
stipulated in paragraph (2) of this Article. However, a detailed report on
the circumstances of the accident and the circumstances of using oil-
eliminating agents shall be made to the competent departments afterwards.
(4) Only those oil-eliminating chemical agents which have been verified
and approved by the competent departments may be used.
Article 18
The operators shall make detailed and accurate entries of the following
circumstances in the anti-pollution record books of the platform;
(1) the operation of the anti-pollution equipment and facilities;
(2) the treatment and discharge of the oil-polluted water;
(3) the treatment, discharge and disposal of other waste materials;
(4) the occurrence of oil-pollution accidents such as oil spill, oil
leakage and well blowout and the handling;
(5) the details about the demolition operations;
(6) details about the use of oil-eliminating chemical agents;
(7) other items stipulated by the competent departments.
Article 19
The enterprises and operators shall, within 15 days from the end of each
quarter of the year, make a comprehensive report in the format approved by
the competent departments on anti-pollution and the circumstances of
pollution accidents of that quarter. The competent departments shall be
informed in good time of the positions of the stationery and mobile
platforms.
Article 20
Government functionaries of the competent departments or the personnel
designated by them have the right to board the stationery and mobile
platforms and other relevant facilities to conduct monitoring and
investigation, including:
(1) collecting various kinds of samples;
(2) inspecting the fitting out, operating and using of various anti-
pollution equipment, facilities and materials;
(3) inspecting relevant documents and certification papers;
(4) checking up on the anti-pollution record books and the relevant
operation records, making copies and extracts when necessary, and
demanding that the responsible persons of the platform sign their names in
confirmation of the copies and extracts in question as correct duplicates;
(5) gathering information about pollution accidents among the persons
concerned;
(6) other related matters.
Article 21
The ships that conduct official business of the competent departments
shall have clear signs. Government functionaries or the designated
personnel, in carrying out official affairs, must wear official uniforms
and carry identity papers.
Those who are investigated shall provide facility for the aforesaid ships,
government functionaries and the designated personnel, and provide
accurate information and statements about the accidents.
Article 22
Units and individuals that have suffered pollution damage caused by
exploration and development of offshore petroleum and are to claim
compensation shall, in accordance with the stipulation of Article 32 of
the Environmental Protection Law of the People's Republic of China and the
stipulation of Article 42 of the Marine Environmental Protection Law of
the People's Republic of China, apply for handling to the competent
departments and claim compensation for the losses from the party that is
responsible for the pollution damage. The claimant shall submit a report
on claiming compensation for damage sustained; this report shall include
the following:
(1) the time, place, scope and the objects of the pollution damage caused
by the exploration and development of offshore petroleum;
(2) a detailed list of the losses caused by pollution damage, including
the names of objects, quantity, unit price, method of calculating, and
such matters as the breeding or natural conditions;
(3) an appraisal by the relevant scientific research department or
endorsement by a notary office in confirmation of the damage actually
sustained;
(4) the original documents of evidence of the pollution damage, the
photographs of the related circumstances and other documents and materials
of testimony relevant to the claim for compensation shall be provided as
complete as possible.
Article 23
Units and individuals (those having commercial contracts excluded) that
demand reimbursement of the expenses for removing pollutants stemming from
the exploration and and development of offshore petroleum shall, in
applying to the competent departments for attention to the case, submit a
report of claiming reimbursement of the expenses for removal to the
competent departments. This report shall include the following:
(2) the manpower, machines and tools and vessels employed, and the
quantities, the unit price and the method of calculating of the materials
used in effecting the removal;
(3) the administrative expenses, transport cost, and other relevant
expenses in organizing the removal effort;
(4) the results of and the situation after the removal;
(5) other relevant evidence and certification papers.
Article 24
Where devastating pollution accidents have occurred due to force majeur,
the enterprises, institutions and operators wishing to free themselves
from the indemnity liabilities thereof shall submit to the competent
departments a report which must be able to testify that the damage
resulting from the pollution accident falls under one of the circumstances
described in Article 43 of the Marine Environmental Protection Law of the
People's Republic of China, and that the accident remained unavoidable
despite rational measures promptly taken.
Article 25
In handling cases of disputes concerning liability for compensation and
the amount of compensation for the pollution damage in the exploration and
development of offshore petroleum, the competent departments shall, on the
basis of investigation and finding out the facts, resort to mediation.
If a party does not want mediation or does not agree to handling of the
matter through mediation by the competent departments, the matter may be
handled in accordance with the stipulation of Article 42 of the Marine
Environmental Protection Law of the People's Republic of China.
Article 26
Where enterprises, institutions and operators violate the Marine
Environmental Protection Law of the People's Republic of China and these
Regulations, the competent departments may order that they take remedial
measures to rectify the situation within a given period of time, pay the
removal costs, and compensate the State for the damage; in cases of
discharge of pollutants in excess of the standard, the payment of a
pollutant discharge fee may be demanded.
Article 27
In cases where enterprises, institutions, operators and individuals
violate the Marine Environmental Protection Law of the People's Republic
of China and these Regulations, the competent departments may punish the
violators by giving warnings or imposing fines according to the
seriousness of the case.
Fines fall into the following categories:
(1) The maximum amount of a fine imposed on an enterprise, institution or
operator that has caused marine environmental pollution is 100,000 RMB
yuan.
(2) The maximum amount of a fine imposed on an enterprise, institution and
operator that has contravened the relevant rules and regulations in the
following ways is 5,000 RMB yuan:
a. not reporting a major oil-pollution accident to the competent
departments according to stipulations;
b. using oil-eliminating chemical agents not according to stipulations.
(3) The maximum amount of a fine imposed on an enterprise, institution or
operator that has contravened the relevant rules and regulations in the
following ways is 1,000 RMB yuan:
a. not having the anti-pollution record book equipped according to
stipulations;
b. the entries in the anti-pollution record book are irregular or false;
c. not reporting to or informing the competent departments of their real
situation according to stipulations;
d. obstructing the government functionaries or the designated personnel
from performing their official duties.
(4) With regard to the directly responsible persons, fines may be imposed
according to the seriousness of the case.
Article 28
If a party does not agree to the penalty by the competent departments, the
matter shall be handled in accordance with the stipulations of Article 41
of the Marine Environmental Law of the People's Republic of China.
Article 29
The competent departments shall grant commendations and rewards to the
units and individuals that on their own initiative report and expose
enterprises, institutions and operators that have concealed pollution
accidents in the exploration and development of offshore petroleum, or
provide evidence, or adopt measures to reduce the damage
Article 30
arising therefrom.
(1) "Stationary and mobile platforms" refers to the well drilling ships,
well drilling platforms and oil extraction platforms referred to in the
Marine Environmental Protection Law of the People's Republic of China, and
includes other platforms.
(2) "Exploration and development of offshore petroleum" refers to such
operational activities as exploration, development, production, storage
and pipeline conveyance.
(3) "Operators" refers to the entities that perform the operations of
exploration and development of offshore petroleum.
Article 31
These Regulations shall go into effect as of the date of promulgation.


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关于国家药品监督管理局医疗器械产品审查注册中心更名的通知


　　各省、自治区、直辖市药品监督管理局，国家药品监督管理局各直属单位： 　　根据中央机构编制委员会办公室《关于国家药品监督管理局医疗器械产品审查注册中心更名的批复》(中央编办复字［2001］102号)，国家药品监督管理局医疗器械产品审查注册中心更名为国家药品监督管理局医疗器械技术审评中心。编制由10名增加至30名，经费自理。 　　特此通知 　　 国家药品监督管理局　　 二○○一年八月二十八日' 文号：国药监办[2001]393号