卫生部关于加强生物医学材料和制品管理的通知
卫生部
卫生部关于加强生物医学材料和制品管理的通知
（１９９２年１０月５日）
近年来，随着科学技术的迅速发展，生物医学材料和制品的临床应用日益增多，在防病治病中发挥了重要的作用。
生物医学材料和制品由医生直接用于人体，它与药品一样，具有不同于一般工农业产品的特殊性，其安全有效性及质量的好坏直接关系到医疗效果和病人的生命安危。很多国家立法由卫生部门对其进行质量监督管理，实行上市前批准制度。
我国生物医学材料和制品的研制较国外起步晚，但发展较快。由于长时间存在着的产品无统一审批，监督管理不完善的原因，以致产品质量不一，产品安全性有效性存在着严重隐患，给临床带来许多新问题，使病人深受其害，厂家对此也有强烈反映。另，近年来国外厂家向卫生部申请进口的产品也日益增多，有的国外厂家趁我国尚未实行上市前批准制度之际，向我国推销其质量低劣或近淘汰品种。据调查，各地医疗单位在使用生物医学材料和制品方面，均不同程度的存在着一些问题，医疗事故时有发生。如采用质量差的高分子材料制成的导管发生断裂、滞留于病人心脏或腹腔内；人工骨易发生碎裂，达不到医疗要求，某地区１００名病人用瓣膜，其中６人发生瓣断装，造成事故，此外，非医用级的工业材料带入对人体有害的杂质潜在的危害也是十分严重的。为此，社会各界呼吁卫生部门尽早对这类产品加强管理。
根据国务院领导关于将生物医学材料和人工脏器的质量监督工作管起来的批示，现决定：
一、由中国药品生物制品检定所承担生物医学材料和制品的技术审核工作；
二、加强临床使用管理。
１．医疗单位购买和使用的生物医学材料和制品，必须有经中国药品生物制品检定所技术审核出具的合格证书。凡使用未经该所技术审核的产品，追查其采购人员直接责任及所在医疗单位领导责任。
２．各省、自治区、直辖市卫生厅（局）负责受理当地生产的生物医学材料和制品的申报工作（见附件要求）。经审查合格的产品须报中国药品生物制品检定所进行技术审核，该所定期公布合格品种及生产厂家名单，并出具合格证书。
３．医疗单位与供货方签定的购销合同必须注明要求供货产品为经中国药品生物制品检定所技术审核确认的合格产品条款及因产品质量问题应予退货（索赔）及损害赔偿的条款。
４．我部将逐步开展对生物医学材料和制品的质量监督管理工作。自１９９２年１１月１日起，对下列产品首批进行技术审核：
（１）人工心脏瓣膜及心脏修补材料制品
（２）人工晶体
（３）计划生育用体内植入物（高分子材料）
（４）逢合线（高分子材料）
（５）种植牙
自１９９３年１０月１日起，未经中国药品生物制品检定所技术审核的上述产品医疗单位不得使用。
请各省、自治区、直辖市卫生厅（局）采取措施做好有关产品申请审核工作，并转发此通知，检查督促本地区医疗单位贯彻执行。
附件： 申报资料要求
一、产品生产国卫生部门批准该产品上市的证明、批准件或卫生部门注册登记号码、附卫生部门ＧＭＰ检查记录报告。
国内产品必须附企业工商执照及上级主管部门证明（可附有关部门发放的许可证、成果鉴定等证明）。
二、产品综述资料：包括产品名称、商标、化学名称、组成成分（配件）结构、适应症、使用说明、注意事项等，国内外该产品研究生产、专利申请及使用情况。
三、产品生产资料：包括工艺流程图、原料、添加剂及中间质量控制。质量标准及检验方法（如国家标准、行业标准或企业标准。ＩＳＯ标准ＡＳＴＭ标准、药典标准或所在国卫生部门批准的标准）。
四、人体外安全性有效性试验资料
五、人体临床试验资料
国外产品报送经所在国卫生部门审核的临床试验资料，国内产品报送以经临床试验资料。
属首次在我国使用的产品报送临床试验计划。
六、产品样品（一至三件）。
中华人民共和国对外国籍船舶管理规则(附英文)
交通部
中华人民共和国对外国籍船舶管理规则(附英文)
（一九七九年八月二十五日国务院批准）
总则
第一条 为维护中华人民共和国的主权，维持港口和沿海水域的秩序，保证航行安全，防止水域污染，特制定本规则。
第二条 在中华人民共和国港口和沿海水域航行的外国籍船舶（以下简称船舶）应遵守本规则以及中华人民共和国一切有关法令、规章和规定。中华人民共和国政府设置在港口的港务监督认为有必要对船舶进行检查时，船舶应接受检查。
本规则所称沿海水域是指属于中华人民共和国的内水和领海以及国家规定的管辖水域。
第一章 进出港和航行
第三条 船长或船舶所有人应在船舶预定到达港口一星期之前，通过外轮代理公司填具规定的表报，向港务监督办理进口申请批准手续，并在到达港口之前二十四小时（航程不足二十四小时的，在驶离前一港口时），将预计到港时间，前、后吃水等情况通过外轮代理公司向港务监督报告。如预计到港时间有变化，应随时报告。船舶在航行途中，因遇险、发生故障、船员或旅客患急病等特殊情况，需临时进港或返航，应事先向港务监督报告。
第四条 船舶进出港口或在港内航行、移泊，必须由港务监督指派引航员引航。有关引航的具体事项，应按照中华人民共和国交通部颁发的《海港引航工作规定》办理。
第五条 船舶抵港后，应即呈报进口报告书及其它有关表报，同时交验船舶证书及有关文书，并接受检查。船舶出港前，应呈报出口报告书及其它有关表报，经检查发给出口许可证后，才可出口。
第六条 船舶上的武器、弹药，应在船舶抵港后由港务监督予以封存。无线电报发射机、无线电话发射机、火箭信号、火焰信号、信号枪，只有在危急情况下才可以使用，但在使用后必须向港务监督报告。
第七条 港内禁止射击、游泳、钓鱼、鸣放鞭炮或焰火以及其它危及港口安全秩序的行为。
第八条 船舶有下列情况之一者，港务监督有权在一定期间内禁止其出港或令其停航、改航、返航：
一、处于不适航状态；
二、违反中华人民共和国的法律或规章；
三、发生海损事故；
四、未缴付应承担的款项，又未提供适当担保者；
五、其它需要禁止航行的情况。
第九条 航行在中华人民共和国港口和沿海水域的船舶，不得进行危害中华人民共和国安全和权益的活动，并应遵守有关海峡、水道、航线和禁航区的规定。
第十条 船舶在港内不得以危及其它船舶和港口设施安全的速度航行。
第十一条 船舶附属的艇（筏），除了救生以外，不准在港内航行。
第十二条 船舶在港内航行、移泊时，船上的艇（筏）、吊货杆和舷梯等，不得伸出舷外。
第十三条 需要进入中华人民共和国对外轮开放的港口避风或临时停泊的船舶应向港务监督申请批准，申请内容包括：船名、呼号、国籍、船公司名称、出发港、目的港、船位、航速、吃水、船体颜色、烟囱颜色和标志，并应在指定的地点避风。
船舶如需在中华人民共和国对外轮开放的港口以外的地点避风或临时停泊，除办理上述申请批准手续外，还应遵守下列规定：
一、及时向就近的港务监督报告抛锚时间、位置和驶离时间；
二、遵守当地有关部门的规定，接受检查和询问，并听从指挥；
三、未经当地有关部门批准，船上人员不得登陆，不得装卸货物。
第二章 停泊
第十四条 船舶在港内停泊，必须留有足以保证船舶安全操纵的船员值班，遇有台风警报等紧急情况，全体船员必须立即回船采取防范、应急等措施。
第十五条 船舶在船员、旅客和其他人员上下之处设置的舷梯必须稳固，并有栏杆或攀索，软梯必须牢固安全，夜间应有足够的照明。
第十六条 船舶需要活车时，必须注意尾部周围环境，在不危及其他船舶和港口设施安全的情况下才可进行。
第十七条 停泊在港内的船舶，其两舷可能影响其他船舶、码头或人员上下的出水口必须加盖复罩。
第十八条 船舶的灯光不得影响其他船舶的航行安全，船上射向航道的强灯光，应予以遮蔽。
第十九条 船舶对装卸操作应提供安全良好的条件，装卸设备应具有合格证书，保持良好的技术状态。
第二十条 船舶进行下列事项，应事先向港务监督申请批准：
一、拆修锅炉、主机、锚机、舵机、电台；
二、试航、试车；
三、放艇（筏）进行救生演习；
四、烧焊（进船厂修理的除外），或者在甲板上明火作业；
五、悬挂彩灯。
第二十一条 船舶熏蒸，应采取严密的安全措施，并应悬挂港口规定的信号。
第二十二条 为了维护港口和船舶的安全，需要在港内的船舶移泊或提前、推迟开航，船舶应遵守港务监督的决定。
第三章 信号和通讯
第二十三条 船舶在中华人民共和国港口和沿海水域航行、停泊，白天应悬挂船籍国的国旗，进出港口和移泊应加挂船名呼号旗和港口规定的有关信号。
第二十四条 船舶在进出港口和锚泊时，应注意港口信号台的呼叫和信号，在使用视觉信号时，应遵守中华人民共和国沿海港口信号规定。沿海港口未曾规定的信号，应依照《国际信号规则》办理。
第二十五条 船舶在港内除因航行安全必须外，不得随意鸣放声号。需要试笛时，应事先向港务监督报告。
第二十六条 船舶在港内使用甚高频无线电话，应遵守中华人民共和国交通部颁发的《关于外轮使用甚高频无线电话暂行办法》。
第四章 危险货物
第二十七条 船舶装卸、载运危险货物，应悬挂规定的信号，遵守有关危险货物运输管理的规定，采取必要的安全措施，特别是性能相抵触的货物，不许混装，严禁爆炸物品与发火物、易燃物品装载于同一舱内。
第二十八条 船舶载运爆炸物品、剧毒物品、放射性物品、压缩气体和液化气体、氧化剂、自燃物品、遇水燃烧物品、易燃液体、易燃固体和酸性腐蚀物品等一级烈性危险货物，应详细列具品名、性质、包装数量和装载位置，并且附具危险货物性质说明书，在预定到达港口三天之前，通过外轮代理公司向港务监督申请办理签证，经许可后才可进港、起卸或者过境。出口船舶载运上述危险货物，应在开始装载的三天以前，申请办理签证，经许可后才可装运。
第二十九条 船舶申请签发装运出口危险货物安全装载证明书，应在开始装载三天之前向港务监督提出书面申请，写明危险货物的品名、性质、包装、数量、装载位置（并且附具货物装载图）、中途港和目的港等事项并在港务监督指定的泊位进行装载。
第五章 航道保护
第三十条 船舶航行应遵守航行规定，维护航行秩序，如船舶发生意外事故有沉没危险时，应立即向港务监督报告，并尽力采取有效措施，驶离航道，避免妨碍交通和危及其他船舶。如果船舶已经沉没，船方应及时在沉没地点设置临时信号标志。
第三十一条 对沉没在港口或沿海水域的船舶或其他物体的打捞，均按照《中华人民共和国打捞沉船、沉物管理办法》办理。港务监督可视具体情况，通知沉船沉物所有人限期打捞清除，或立即组织打捞或解体清除，全部责任和费用应由沉船沉物所有人承担。
第三十二条 船舶发现或捞获沉、浮物体，应报告或送交港务监督处理，由港务监督酌情给予奖励。
第三十三条 船舶在港内需要倾倒垃圾等废弃物，应显示港口规定的信号招用垃圾船（车）。
第三十四条 船舶应爱护航道设备和助航标志，如损坏了助航标志、港口建筑或其他设施，应立即向港务监督报告，并应负责恢复原状或偿付恢复原状所需费用。
第六章 防止污染
第三十五条 在中华人民共和国的港口和沿海水域，禁止船舶任意排放油类、油性混合物，以及其他有害的污染物质和废弃物。
第三十六条 船舶排放压舱水、洗舱水、舱底水，必须向港务监督申请批准。如果船舶来自有疫情的港口，应经过卫生检疫机关卫生处理。装运危险货物和其他有害污染物船舱的污水、洗舱水，应经有关卫生部门鉴定合格后，方可在指定地点排放。
第三十七条 凡油轮和使用燃油的船舶，应备有油类记录簿，并且按照记录簿各项规定及时如实记载。
第三十八条 如船舶在港口和沿海水域发生污染事故，应将经过情况分别纪入油类记录簿和航海日志，并立即向港务监督报告，同时必须采取有效的措施防止扩散。如需采用化学剂处理，应提供化学成份说明书，向港务监督申请批准。
第三十九条 本章未列事项，按照中华人民共和国有关防止水域污染的规定办理。
第七章 消防和救助
第四十条 严禁在货舱以及易于引起船舶火警的场所吸烟和弄火。
第四十一条 船舶加油和油船装卸作业，应采取严密的防火安全措施。
第四十二条 船舶在港内进行烧焊等工程，应事先清理周围环境，采取严密防范措施，配备消防设备，并且在施工前后进行检查。对油舱及其邻近部位还必须卸完全部油料，清除残油，彻底通风，排除其内部易燃气体，并取得合格证明之后，才可以烧焊。
第四十三条 船舶失火或发生海难，应立即将出事地点和本船吨位、吃水、载货、受损和需要某种援助等情况报告港务监督。
第四十四条 港务监督在必要时，可动员和指挥在港内或沿海水域的船舶参加救助遇难船舶，在不影响本船安全的情况下，被动员的船舶有责任尽力救助。
第四十五条 港务监督或救助部门的负责人员到达现场，遇难船舶的船长应立即报告失事情况及已经采取的措施，提供救助必需的资料和方便，并且可以提出有关救助的建议。港务监督为维护安全秩序作出的决定，有关方面必须遵守。
第八章 海损事故
第四十六条 船舶发生海损事故，应尽速用电报或无线电话向港务监督报出扼要报告。在港区以外发出的海损事故，船长应在船舶进入第一港口四十八小时内，向港务监督递交海损事故报告书；在港区内发生的海损事故，船长应在二十四小时内向港务监督递交海损事故报告书。
第四十七条 船舶在中华人民共和国港口和沿海水域造成人命、财产损害事故时，应积极救助受害的船舶和人员，及时向港务监督报告，并接受调查和处理。如果肇事者见危不救，隐匿逃遁，将从严处理。
第四十八条 船舶发生船员死亡事故，应立即向港务监督报告。在港内由于船方或港方人员的过失，造成对方损害或伤亡事故等，应保留现场，双方都应及时向港务监督报告。如果发生纠纷，当事的任何一方，都可以向港务监督申请调查处理，涉及刑事范围的，由中华人民共和国司法机关处理。
第四十九条 本章未列事项，按照中华人民共和国交通部颁发的《海损事故调查和处理规则》办理。
第九章 违章处罚
第五十条 凡违反本规则以及中华人民共和国一切有关法令、规章和规定者，港务监督得按其性质、情节分别给予警告、罚款等处分，性质恶劣、情节严重者移交司法机关处理。
第五十一条 受处分者如果对所受处分不服，可以在接到通知的次日起十五日之内，向中华人民共和国港务监督局提出申诉。但在没有变更决定之前，原处分仍为有效。
第十章 附则
第五十二条 关于船舶避碰，本规则和中华人民共和国其他有关规定中未列事项，依照中华人民共和国施行的《国际海上避碰规则》办理。
第五十三条 本规则由中华人民共和国国务院批准施行，中华人民共和国交通部一九五七年三月十二日颁发的《中华人民共和国对外国籍船舶进出港口管理办法》同时废止。
RULES OF THE PEOPLE'S REPUBLIC OF CHINA GOVERNING VESSELS OFFOREIGN NATIONALITY
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)
RULES OF THE PEOPLE'S REPUBLIC OF CHINA GOVERNING VESSELS OF
FOREIGN NATIONALITY
(Approved by the State Council on August 25, 1979) and promulgated
by the Ministry of Communications on September 18, 1979)
General Provisions
Article 1
These Rules are formulated in order to safeguard the sovereignty of the
People's Republic of China, maintain the order of ports and coastal
waters, ensure the safety of navigation and prevent the pollution of
waters.
Article 2
All vessels of foreign nationality sailing in the ports and coastal waters
of the People's Republic of China (hereinafter referred to as "vessels")
shall abide by these Rules and all the relevant decrees, stipulations and
provisions of the People's republic of China. Whenever the Harbour
Superintendency Administration set up by the Government of the People's
Republic of China is of the view that it is necessary to conduct
inspection of vessels, the vessels must subject themselves to inspection.
The term coastal waters as used in these Rules refers to the inland waters
and territorial seas of the People's Republic of China and the waters
stipulated by the State to be under its jurisdiction.
Chapter I Port Entry and Exit and Navigation
Article 3
The captain or the ship owner shall, through the China Ocean-shipping
Agency Corporation, one week before the scheduled arrival of his vessel at
a port, fill in the prescribed forms and go through the procedures to
apply for approval of port entry with the Harbour Superintendency
Administration and, 24 hours before the vessel's arrival at the port (or
if the voyage is less than 24 hours, at the time of departure from the
previous port), through the agent company for foreign vessels, report to
the Harbour Superintendency Administration on the scheduled time at
arrival, forward draft, stern draft, and other such conditions. A report
shall be made at any time if any change at the time of arrival is
anticipated. If in the course of its voyage, a vessel has to enter or
return to the port temporarily due to special circumstances such as
mishap, malfunction, or acute illness contracted by its seamen or
passengers, a report shall be made to the harbour Superintendency
Administration in advance.
Article 4
When a vessel goes into or out of a port or sails or changes berths in it,
it shall be guided by a pilot appointed by the Harbour Superintendency
Administration. The specific matters concerning pilotage shall be handled
in accordance with the "Provisions for Pilotage in Ports" promulgated by
the Ministry of Communications of the People's Republic of China.
Article 5
Upon arrival of a vessel at a port, the entry and other relevant reports,
together with the certificate of registry and relevant documents shall be
submitted promptly for examination, and the vessel shall be subject to
inspection. Before a vessel goes out of a port, the exit and other
relevant reports shall be submitted and the vessel may go out only with an
exit permit issued after inspection.
Article 6
All weapons and ammunition on board a vessel shall be k ept under seal by
the Harbour Superintendency Administration upon arrival of the vessel at
the port. Radio telegraph transmitters, radio telephone transmitters,
rocket signals, flame signals and signal guns shall only be used in
conditions of emergency; and after such use, reports must be made to the
Harbour Superintendency Administration.
Article 7
It shall be forbidden, inside a port, to shoot, swim, fish or set off
fire-crackers or fireworks or do other acts likely to endanger the safety
and order of the port.
Article 8
The Harbour Superintendency Administration shall be entitled to prohibit a
vessel from going out of the port within a specified period of time, or
order it to suspend its voyage, change its course or return to the port if
the vessel is in any of the following conditions:
1. in an unseaworthy condition;
2. in contravention of the laws or regulations of the People's Republic of
China;
3. having involved in an accident of marine damage;
4. having failed to pay prescribed dues and to provide an appropriate
guarantee therefor;
5. other conditions which call for prohibition of navigation.
Article 9
Vessels sailing in the ports and coastal waters of the People's Republic
of China shall not engage in activities detrimental to the security,
rights and interests of the People's Republic of China and shall abide by
the provisions concerning straits, waterways, navigation lines and
restricted zones.
Article 10
Vessels shall not sail at such speed in ports as to endanger the safety of
other vessels and port facilities.
Article 11
The boats (rafts) attached to vessels shall not be allowed to sail in
ports except for lifesaving purposes.
Article 12
When sailing or changing berths in ports, vessels shall not have their
attached boats (rafts), derricks, gangways, etc. extended over the board
sides.
Article 13
Vessels that have to enter into a port of the People's Republic of China
which is open to foreign vessels for the purpose of taking shelter or
temporary berth shall apply to the Harbour Superintendency Administration
for approval; the application shall include: the ship's name, call sign,
nationality, name of the carrier, port of departure, port of destination,
ship's position, speed, draft, hull colour(s), funnel colour(s) and mark,
and shall take shelter at the specified place.
Vessels that have to take shelter or temporary berth in a place other than
the ports open to foreign vessels of the People's Republic of China shall,
in addition to going through the above procedures for the application for
approval, abide by the following:
1. duly report to the Harbour Superintendency Administration in the
neighbourhood on the anchoring time, position and the time of departure;
2. observe the provisions of the relevant local departments, subject
itself to inspection and enquiry and obey orders;
3. the personnel on board the vessel shall not come to land nor shall the
goods on board be unloaded without the approval of the relevant local
departments.
Chapter II Berthing
Article 14
Vessels berthed in a port shall have on duty a number of seamen sufficient
to ensure the safe operation of the vessel and, in times of a typhoon
warning or other emergency conditions, all crew members shall immediately
return on board to take preventive and other measures.
Article 15
The gangways of a vessel set up where the crew members, passengers and
other personnel embark and disembark shall be firm and secure and armed
with rails or hand ropes; rope ladders shall be firm and safe, with
adequate illumination at night.
Article 16
When a vessel has to start its engine, attention shall be paid to the
surroundings of the stern and it shall only be done in circumstances where
the safety of other vessels and port facilities will not be endangered.
Article 17
The water outlets on both sides of a vessel berthed in a port, which are
likely to affect other vessels, the pier or the embarkation and
disembarkation of personnel shall be covered.
Article 18
The light of a vessel shall not affect the safety of navigation of other
vessels and strong lights of the vessel projected towards the course of
navigation shall be blocked.
Article 19
Vessels shall provide safe and good conditions for loading and unloading
operations and the loading and unloading installations shall possess
certificates of compliances and be maintained in good technical condition.
Article 20
A vessel shall make prior applications to the Harbour Superintendency
Administration for approval to carry out the following operations:
1. dismantling and repair of boilers, main engine, windlasses, steering
gear and transmitters;
2. trial voyages and trial runs;
3. setting down boats (rafts) to carry out lifesaving rehearsal;
4. welding or soldering (except for repair in a dockyard) or carrying out
operations with uncovered light on the deck;
5. hanging out decorative lamps.
Article 21
In the fumigation of a vessel, strict safety measures shall be taken and
the signal stipulated by the Port shall be hoisted.
Article 22
To ensure safety of the port and vessels, the decisions of the Harbour
Superintendency Administration shall be complied with if any ship has to
change berths in the port or set sail ahead of schedule or postpone
sailing.
Chapter III Signals and Communication
Article 23
Vessels sailing or berthed in the ports and coastal waters of the People's
Republic of China shall fly the national flags of their countries of
registry in daytime. When coming into or going out of the ports or
changing berths, they shall additionally fly their vessel flags for call
and the relevant signals stipulated by the port.
Article 24
When coming into or going out of the port or anchoring, vessels shall pay
attention to the calls and signals of the port signal station and shall
observe the regulations of the People's Republic of China for signals in
coastal ports in the use of visual signals. In respect of signals not yet
stipulated by coastal ports, "International Rules for Signals" shall be
observed.
Article 25
Vessels in ports shall not send out sound signals at will except out of
necessity for navigation safety. When it is necessary to test whistles, a
report shall be submitted to the Harbour Superintendency Administration in
advance.
Article 26
In the use of very high frequency radio telephones in ports, vessels shall
abide by the "Interim Measures for the Use of Radio Telephones of Very-
high-frequency by Vessels of Foreign Registry" promulgated by the Ministry
of Communications of the People's Republic of China.
Chapter IV Dangerous Goods
Article 27
In loading, unloading or transportation of dangerous goods, the vessels
shall hoist the stipulated signals, observe the stipulations for the
administration of the transportation of dangerous goods and take necessary
safety measures. In particular, goods with mutually-conflicting properties
shall not be loaded in a mixed way and it shall strictly be prohibited to
load explosive articles together with igniters or combustible articles in
the same holds.
Article 28
In carrying Class-1 strongly dangerous goods such as explosive articles,
deadly poisonous articles, radioactive articles, compressed gases and
liquefied gases, oxidizers, spontaneous combustible articles, articles
that ignite when in contact with water, combustible liquids, combustible
solids and acid corrosives, vessels shall list in detail the names of the
goods, their properties, package, quantity and loading position, and also
attach the instructions concerning the properties of the dangerous goods
to the lists and apply to the Harbour Superintendency Administration
through the agent companies for foreign vessels for clearance visas three
days before their scheduled arrival at the ports. Only with approval may
they enter the port, unload goods, or pass through the transit. To carry
the above mentioned dangerous goods, outgoing vessels shall apply for
clearance visas three days before the start of loading. Only with
approval may they load and carry.
Article 29
In applying for the safety certificates for loading and carrying dangerous
goods for export, vessels shall make written applications to the Harbour
Superintendency Administration three days before the start of loading,
clearly stating the names of the dangerous goods, their properties,
package, quantity, loading position (also attached with loading plans of
the goods), midway ports, port of destination, etc. Loading shall be done
at the berths specified by the Harbour Superintendency Administration.
Chapter V Safeguard of Navigation Lanes
Article 30
In navigation, vessels shall abide by the provisions for and maintain the
order of navigation. If a vessel encounters an accident and is in danger
of sinking, it shall promptly report to the Harbour Superintendency
Administration and take effective measures as best as it can to sail out
of the lane so as not to obstruct navigation and endanger other vessels.
If the vessel has sunk, the vessel side shall duly set up a temporary
signal mark at the place of its sinking.
Article 31
The salvage of vessels or other articles which have sunk in the ports or
coastal waters shall be handled in accordance with the "Measures of the
People's Republic of China for the Administration of the Salvage of Sunken
Vessels and Sunken Articles". The Harbour Superintendency Administration
shall, according to particular circumstances, notify the owners of the
sunken vessels or sunken articles to salvage and remove them within a
prescribed period, or promptly organize the salvage or dismantlement and
removal; the entire responsibilities and expenses shall be borne by the
owners of the sunken ship and sunken articles.
Article 32
If a vessel, finds or dredges up any sunken or floating article, it shall
report, or hand it over for handling, to the Harbour Superintendency
Administration, which shall give awards at its discretion.
Article 33
If a vessel has to dump rubbish and other refuse in a port, it shall
display the signal stipulated by the port to call up a rubbish boat (or
truck).
Article 34
Vessels shall take good care of lane installations and navigational aids.
If a vessel has damaged any navigational aid, port construction or other
facilities, it shall promptly report to the Harbour Superintendency
Administration and undertake to restore them or pay compensation for the
restoration.
Chapter VI Prevention of Pollution
Article 35
In the ports and coastal waters of the People's Republic of China, vessels
shall be prohibited from wilfully draining away oils, oil mixtures and
other pernicious pollutants and wastes.
Article 36
Vessels shall apply to the Harbour Superintendency Administration for
approval for draining away ballast water, washing water from holds or
bilge water. A vessel that comes from an epidemic-affected port shall go
through the hygienic treatment of the quarantine. The bilge water and
washing water from the holds of vessels carrying dangerous goods and other
pernicious pollutants may be drained at specified places only after
appraisal which indicates that they meet the standards of the public
health department concerned.
Article 37
All oil tankers and vessels using fuel oil shall possess oils registers
and duly and truly make entries therein in accordance with various
provisions of the registers.
Article 38
If polluting accidents occur with vessels in the ports or coastal waters,
they shall record the course of events separately in their oils registers
and sea logs, promptly report to the Harbour Superintendency
Administration and at the same time take effective measures to prevent
diffusion of the pollutants. If treatment with chemicals is required, it
is necessary to apply to the Harbour Superintendency Administrations for
approval, and provide them with the instructions of the chemical
ingredients.
Article 39
Matters not included in this chapter shall be handled in accordance with
the provisions of the People's Republic of China relating to the
prevention of pollution of waters.
Chapter VII Fire Control and Rescue
Article 40
It shall strictly be forbidden to smoke or make fires in cargo holds or
other places prone to fire on board the vessels.
Article 41
Strict fire-prevention and safety measures shall be taken for the
refueling of vessels and for the loading and unloading operations of oil
tankers.
Article 42
To perform such engineering projects as welding or soldering on board a
vessel, the surroundings, shall be cleared in advance, strict precaution
measures be taken, firefighting equipment be made ready and inspection be
conducted before and after the operations. The oil tanks and their
adjacent parts shall necessarily be emptied of all oil materials, cleared
of residues of oil, thoroughly ventilated, with their internal combustible
gases discharged and certified as up-to-standard before welding or
soldering can be carried out.
Article 43
If a vessel catches fire or encounters a sea peril, it shall promptly
report to the Harbour Superintendency Administration such conditions as
scene of the accident, tonnage of vessel, draft, cargo carried, damages,
and the kind of assistance required.
Article 44
If necessary, the Harbour Superintendency Administration may mobilize and
command the vessels in the port or coastal waters to take part in the
rescue of a vessel in trouble and under the circumstances that their own
safety will not be affected, the mobilized vessels have the responsibility
to partake in the rescue as best as they can.
Article 45
When the Harbour Superintendency Administration or leading members of the
rescue department arrive at the scene, the captain of the vessel in
trouble shall promptly report the state of the accident and the measures
which have been taken and supply the data and facilities required for the
rescue. He may also make suggestions concerning the rescue. The parties
concerned shall observe the decisions made by the Harbour Superintendency
Administration for the maintenance of security and order.
Chapter VIII Accidents of Damages at Sea
Article 46
When an accident of damages at sea occurs to a vessel, it shall make a
summary report to the Harbour Superintendency Administration by telegraph
or radio-telephone as soon as possible. With regard to the occurrence of
an accident of damages at sea outside a port area, the captain shall
submit a report about the accident to the Harbour Superintendency
Administration within forty-eight hours of the vessel's entry into the
first port of call. With regard to the occurrence of an accident of
damages at sea within the port, the captain shall submit a report about
the accident to the Harbour Superintendency Administration within 24
hours.
Article 47
When a vessel causes an accident in the port or coastal waters of the
People's Republic of China, which results in the loss of human life and
damage to property, it shall actively attempt to rescue the damaged vessel
and injured personnel, promptly report the matter to the Harbour
Superintendency Administration and subject itself to investigation and
handling. The troublemaker who does not rescue those in danger but hides
itself or runs away shall be severely dealt with.
Article 48
If the death of a seaman occurs on board a vessel, the vessel shall
promptly make a report to the Harbour Superintendency Administration. If
the default of personnel of the vessel side or the port side gives rise to
damage or injury or death to the other side, the scene shall be kept
intact and both sides shall duly report to the Harbour Superintendency
Administration. If a dispute occurs, any party concerned may apply to the
Harbour Superintendency Administration for investigation and handling.
Those involving crimes shall be dealt with by the judicial organs of the
People's Republic of China.
Article 49
Matters which are not included in this Chapter shall be handled in
accordance with the "Rules for the Investigation and Handling of Accidents
of Damage at Sea promulgated by the Ministry of Communications of the
People's Republic of China.
Chapter IX Punishments on Contravention of Regulations
Article 50
The Harbour Superintendency Administration shall impose such punishments
as a warning or a fine, according to the nature and seriousness of the
offence, on anyone who has contravened these Regulations and any other
relevant decrees, provisions and regulations of the People's Republic of
China. Those of a vile and serious nature shall be handed over to, and
dealt with by, the judicial organs.
Article 51
If the punished party does not accept the punishment, he can make an
appeal to the Harbour Superintendency Administration of the People's
Republic of China within 15 days of receipt of the notice. Before
alteration of the decision, however, the original punishment shall still
take effect.
Chapter X Supplementary Provisions
Article 52
With regard to the prevention of collision of vessels, matters which are
not included in these Regulations and other relevant provisions of the
People's Republic of China shall be handled in accordance with the
"International Rules For the Avoidance of Collision at Sea" implemented by
the People's Republic of China.
Article 53
These Regulations shall be put into effect as of the date of promulgation
by the State Council of the People's Republic of China. Concurrently
therewith, the "Measures of the People's Republic of China For the
Administration of Port Entry and Exit by Vessels of Foreign Registry"
promulgated by the Ministry of Communications of the People's Republic of
China on March 12, 1957 shall be annulled.
