TRUST LAW
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CIRCULAR OF THE GENERAL ADMINISTRATION OF CUSTOMS AND THE MINISTRY OF FOREIGN TRADE AND ECONOMIC COOPERATION ON REITERATING THE PROVISIONS ON THE PROCEDURES FOR RATING THE CATEGORIZED MANAGEMENT OF ENTERPRISES
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2001061920010619The State Environmental Protection AdministrationOrder of the State Environmental Protection AdministrationNo.10The Measures on the Administration of Organic Food Certification have been adopted at the bureau affairs meeting of State Environmental Protection Administration held on April 27, 2001, and are hereby promulgated for implementation.Director General of State Environmental Protection Administration Xie ZhenhuaJune 19, 2001epdf/e01890.pdfMorganic foods, foods, food certificatione01890Measures of the State Environmental Protection Administration on the Administration of Organic Food CertificationChapter I General ProvisionsArticle 1 These Measures are formulated with a view to standardizing the administration of organic food certification, promoting the healthy and orderly development of organic foods, preventing pollution and destruction of such chemical materials as pesticide and fertilizer, etc. to the environment, guaranteeing the health of human body, and protecting the ecological environment.Article 2 Organic foods mentioned in these Measures mean the agricultural products and the products processed from them, which meet the following conditions:(1)meeting the requirements of State standards on food hygiene and the technical specifications for organic foods;(2)not using such chemical materials as pesticide, fertilizer, growth hormone, chemical additive, chemical pigment and antiseptic, etc. in the process of producing materials or processing products, and not using the genetic engineering technology;(3)having passed the certification of the organic foods certification institution provided in these Measures and using the mark of organic foods.Article 3 These Measures shall apply to the entities and individuals engaged in organic food certification or production and operation of organic foods within the territory of the People’s Republic of China.Chapter II Administration on Organic Food Certification InstitutionArticle 4 The State shall implement qualification examination on organic food certification institutions. An entity engaged in organic food certification must, in accordance with the procedures provided in these Measures, apply to the Organic Food Ratification Committee established by State Environmental Protection Administration for obtaining the qualification certificate for organic food certification institution.Article 5 An entity applying for a qualification certificate for organic food certification institution shall meet the following requirements:(1)having an independent qualification as a legal person;(2)having 3 or more technicians with senior technical post_titles in relevant specialties and 5 or more technicians with intermediate technical post_titles in relevant specialties, who are engaged in full-time organic food certification;(3)having funds, facilities, fixed working site and other relevant working conditions which the organic food certification requires.Article 6 An entity applying for the qualification certificate for organic food certification institution shall file the application to the Organic Food Ratification Committee, and meanwhile submit the following documents:(1)attesting documents on the qualification as a legal person;(2)attesting documents on the qualifications of the full-time technicians;(3)attesting material on the organic food certification such as funds, facilities, fixed working site and other relevant working conditions;(4)other documents required by the Organic Food Ratification Committee.Article 7 The Organic Food Ratification Committee shall, within 20 days as of its receipt of the application documents, make a decision on whether to accept the application or not, and notify the applying entity in writing. It shall state the reason if the application is not accepted.Article 8 The Organic Food Ratification Committee shall complete the examination within 40 days as of its acceptance of the application.The Organic Food Ratification Committee shall issue the qualification certificate for organic food certification institution to the entity that is examined and has met the qualification requirements.An entity may not be engaged in the organic food certification before obtaining the qualification certificate for organic food certification institution.Article 9 The qualification certificates for organic food certification institution shall be made and issued by the Organic Food Ratification Committee.No entity or individual shall forge, alter or transfer the qualification certificate for organic food certification institution.Article 10 An organic food certification institution shall comply with the following principles in organic food certification:(1)justness, fairness and independence;(2)making known the standards, procedures and results of certification;(3)maintaining clients’ technological and business secrets.Article 11 An organic food certification institution shall accept the supervision and inspection of the Organic Food Ratification Committee on its certification.An organic food certification institution shall carry out regular inspections on the organic foods certified by itself.Article 12 An organic food certification institution shall, within 1 month after it issues the certificate of organic food certification, submit a copy of the said certificate issued by itself to the Organic Food Ratification Committee for record.Different organic food certification institutions shall cooperate with each other, and share the information on certification.Article 13 An organic food certification institution shall submit an annual work report of the last year to the Organic Food Ratification Committee by January 15 of each year, and shall accept the assessment in the annual inspection of the Organic Food Ratification Committee.Article 14 An organic food certification institution and its employees shall not be engaged in the non-gratuitous consultation or the production and operation of organic foods.Article 15 An organic food certification institution shall carry out the organic food certification in compliance with the principles and procedures provided in these Measures and the technical specifications provided by the Organic Food Ratification Committee, and shall not practice frauds or deceive the clients.Chapter III Certification Administration of Organic Food Production and OperationArticle 16 An entity or individual engaged in the production or operation of organic foods must, in accordance with the provisions in this Chapter and the type of the operation of organic food it plans to be engaged in, apply to the organic food certification institution for the following types of organic food certifications, so as to obtain the corresponding certificate of organic food certifications:(1)certification on base production of organic foods;(2)certification on the processing of organic foods;(3)certification on the trading of organic foods.Article 17 An entity or individual applying for organic food certification shall file a written application for certification to the organic food certification institution, and provide its/his business license or other qualification documents that can prove its/his lawful operation.For an application for certification on base production of organic foods, a report on the quality of the base environment and other relevant documents provided in the technical specifications on organic foods must be submitted in addition.For an application for certification on the processing of organic foods, the following documents must be submitted in addition: an attestation proving the sources of processing materials to be organic foods, the executive standards for the products, the processing technology (flow, procedures), the attestation issued by the administrative department for environmental protection at the city (region) level or above that the processing enterprise’s pollution discharge is reasonable and below the limit permitted, and the other relevant documents provided in the technical specifications on organic foods.For an application for certification on the trading of organic foods, an attestation proving the sources of the traded products to be organic foods and the other relevant documents provided in the technical specifications on organic foods must be submitted in addition.Article 18 An organic food certification institution shall, within 10 days after receiving the written application for certification and the relevant documents, give its opinion on whether to accept the application or not, and shall state the reason if the application is not accepted.Article 19 An organic food certification institution shall organize and complete the certification within 90 days as of the date when it agrees to accept the application.If an entity or individual is certified to be qualified, the organic food certification institution shall issue to it/him the certificate for base production of organic foods, the certificate for the processing of organic foods and the certificate for the trading of organic foods (hereinafter referred to as the certificate of conformity of organic food certification in general) on the basis of the application and the type of the organic food certifications.Article 20 The format of the certificate of conformity of organic food certification shall be uniformly stipulated by the Organic Food Ratification Committee.The certificate of conformity of organic food certification must be used within the defined scope.No entity or individual shall forge, alter or transfer the certificate of conformity of organic food certification.Article 21 The validity period of a certificate of conformity of organic food certification shall be two years.Where an entity or individual producing or operating organic foods needs to continue using the certificate of conformity of organic food certification after the validity period of the said certificate has expired, it/he must file a new application to the original organic food certification institution within 1 month before the expiry of the validity period; the entity or individual who has not obtained the re-certification for the organic foods in operation shall not continue using the certificate of conformity of organic food certification.Article 22 The inspection and test on the samples of organic food certification shall be made by an inspection institution recognized by the relevant department.The monitoring work on the quality of the base environment for organic foods shall be undertaken by the environmental monitoring station affiliated to the administrative department for environmental protection at the city (region) level or above.Article 23 Where, within the validity period of the certificate of conformity of organic food certification, an entity or individual producing or operating organic foods is under any of the following circumstances, it/he shall go through the modification formalities in the organic food certification institution:(1)the entity or individual holding such a certificate has changed;(2)the type (specification) of the product has been changed;(3)the name of the product has been changed;(4)a new trademark is used;(5)the sources of processing materials for the organic foods or the sources of the traded products for the organic foods have been changed.Article 24 An entity or individual engaged in the production or operation of organic foods shall abide by the following provisions:(1)it/he shall accept the supervision and inspection of the organic food certification institution;(2)it/he shall, in case of any modification in the certified contents, report the modification to the organic food certification institution and go through the formalities for the modification;(3)it/he shall keep the files for the operation and management system and files for the production, processing and trading of the organic foods;(4)it/he must, when publicizing the organic foods, guarantee the authenticity of the publicized contents;(5)it/he shall hold post trainings for the employees engaged in the business of organic foods in its/his own entity.Article 25 An entity or individual who has obtained the certificate for base production of organic foods shall define the regional scope, mark the location, set up a protection mark, and make an announcement in time.Chapter IV Administration on the Marks of Organic FoodsArticle 26 An entity or individual who has obtained the certificate of conformity of organic food certification may use the mark of organic foods on the labels, packages, advertisements and guidebooks of the products provided in its/his certificate of conformity of organic food certification.Article 27 The figure and pattern of the mark of organic foods shall be uniformly provided by the Organic Food Ratification Committee.When the mark of organic foods is used, it may be magnified or minified in equal proportion according to the needs, but its shape or color shall not be changed.When the mark of organic foods is used, the number of the certificate of conformity of organic food certification for the product shall be printed below the figure of the mark at the same time.Article 28 The mark of organic foods must be used within the defined scope.Article 29 No entity or individual shall forge, alter or transfer the mark of organic foods.Article 30 An entity or individual producing or operating organic foods must, when the organic foods are polluted or mixed up with inorganic foods in the process of production, processing or sale, inform the original organic food certification institution of the situation in time, cease using the mark of organic foods on such foods, and shall not produce, process or sell them as organic foods.Chapter V Penalty ProvisionsArticle 31 If an organic food certification institution commits any of the following acts in violation of these Measures, it shall be given a warning by the Organic Food Ratification Committee, and be required to make a rectification within a time limit; where it fails to meet the requirements within the said time limit, its qualification certificate for organic food certification institution shall be canceled:(1)to forge, alter or transfer the qualification certificate for organic food certification institution in violation of Paragraph 2, Article 9 of these Measures;(2)to be assessed unqualified in the annual inspection;(3)to be engaged in the non-gratuitous consultation or in the production and operation of organic foods in violation of Article 14 of these Measures;(4)to practice frauds or deceive the clients in the process of certification in violation of Article 15 .Article 32 Where any certified organic foods do not meet the requirements on the standards or specifications in the certificate of conformity of organic food certification, the original organic food certification institution shall temporarily withhold the said certificate or revoke it according to the specific situation.Chapter VI Supplementary ProvisionsArticle 33 These Measures shall come into force as of the date of their promulgation. The Articles of Association on the Administration of the Marks of Organic (Natural) Foods (for trial implementation) promulgated by the original State Environmental Protection Administration in 1995 shall be repealed simultaneously. |
The State Environmental Protection Administration
2001-06-19
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e00137
The Standing Committee of the National People’s Congress Order of the President of the People’s Republic of China No.49 Adopted at the 27th meeting of the Standing Committee of the seventh National People’s Congress on September 4, 1992; Amended in accordance with the Decisions on Amending the Law of the People’s Republic of China Concerning the Administration of Tax Revised at the 21st meeting of the Standing Committee of the ninth National People’s Congress on April 28, 2001 The Law of the People’s Republic of China Concerning the Administration of Tax Collection, revised and adopted at the 21st meeting President of the People’s Republic of China: Jiang Zemin April 28, 2001 Law of the People’s Republic of China Concerning the Administration of Tax Collection Chapter I General Provisions Article 1 This law has been formulated with a view to strengthening the administration of tax collection, regulating tax collection and payment, Article 2 This Law shall apply to the administration of tax collection in respect of all taxes collected by tax authorities in accordance with Article 3 The collection of tax or the cessation thereof, the reduction, exemption and refund of tax as well as the payment of tax dodged or Article 4 Entities or individuals obligated to pay taxes prescribed in the laws or administrative regulations are the taxpayers. Entities or individuals obligated to withhold and remit taxes or collect and remit taxes prescribed in the laws or administrative Taxpayers or withholding agents must pay taxes, or withhold and remit taxes or collect and remit taxes in accordance with the law Article 5 The competent tax departments under the State Council shall be in charge of the administration of tax collection for the whole country. No entities or individuals shall impede the tax authorities from performing duties in accordance with the law. Article 6 The State shall systematically furnish the tax authorities at all levels with modern information technologies, strengthen the modernization Taxpayers, withholding agents and other relevant entities shall, in accordance with relevant provisions of the State, truthfully provide Article 7 Tax authorities shall extensively disseminate tax laws and administrative regulations, the knowledge of tax payment, and gratuitously Article 8 Taxpayers and withholding agents shall have the right to inquire of the tax authorities about the tax laws and administrative regulations Taxpayers and withholding agents shall have the right to require the tax authorities to maintain confidentiality for the information Taxpayers shall, in accordance with the law, have the rights to apply for the reduction, exemption and refund of tax. Taxpayers and withholding agents shall have the right to statement and the right of defense to the decisions made by tax authorities; Taxpayers and withholding agents shall have the right to bring charges against or make exposure of any tax authority or tax official Article 9 Tax authorities shall make the effort to make their officials qualified and efficient for their duties. Tax authorities and tax officials must enforce the law impartially and devote themselves to their duties, be clean and honest, treat Tax officials shall not extort or take bribes, commit fraudulence for selfish purposes, neglect their duties, or fail to collect or Article 10 The tax authorities at all levels shall establish and amplify the administrative system of interior restriction and supervision. The tax authorities at the upper levels shall supervise the enforcement of the law of the tax authorities at the lower levels in accordance The tax authority at each level shall supervise and inspect its officials on the enforcement of laws and administrative regulations Article 11 The duties of the officials in a tax authority who are respectively responsible for collection, administration, check and administrative Article 12 Where any tax official has a personal interest with the taxpayer or withholding agent or in the case in violation of tax laws, when Article 13 Any entity or individual shall have the right to make exposures of any acts committed in violation of the law or the administrative Article 14 The “tax authorities” in this Law means the tax bureaus at all levels, their sub- bureaus, tax stations and tax institutions which Chapter II Tax Administration Section 1 Tax Registration Article 15 Any of the enterprises, branches in other localities established by such enterprises, sites engaged in production or business operations, The administrative authorities for industry and commerce shall regularly inform tax authorities of the registration and issuance of The scope of and methods for tax registration by taxpayers and for tax withholding registration formalities by withholding agents Article 16 Where a change occurs in the contents of tax registration of a taxpayer engaged in production or business operations, the taxpayer Article 17 A taxpayer engaged in production or business operations shall, in accordance with relevant provisions of the State, open a basic deposit The bank or other financial institution shall record the numbers of the tax registration certificates in the accounts of the taxpayer When a tax authority is inquiring about the opening of account of a taxpayer engaged in production or business operations in accordance Article 18 Taxpayers shall use tax registration certificates in accordance with the provisions formulated by the competent tax departments under Section 2 Administration of Accounting Books and Supporting Vouchers Article 19 Taxpayers or withholding agents shall establish accounting books in accordance with relevant laws and administrative regulations, Article 20 The financial and accounting systems or methods and the accounting software of a taxpayer engaged in production or business operations Where the financial and accounting systems or methods of a taxpayer or a withholding agent are in conflict with the relevant tax provisions Article 21 A tax authority is the authority in charge of invoices, and is responsible for the administration and supervision of the printing, A entity or individual shall, when purchasing or selling commodities, providing or accepting operational services, and being engaged The measures on the administration of invoices shall be formulated by the State Council. Article 22 Special VAT invoices shall be printed by enterprises designated by the competent tax departments under the State Council; other invoices No enterprises are permitted to print invoices without authorization by the competent tax departments prescribed in the preceding Article 23 The State may, based on the needs on the administration of tax collection, actively extend and apply tax-control facilities. Taxpayers Article 24 Taxpayers or withholding agents engaged in production or business operations must maintain accounting books, supporting vouchers for Section 3 Filing Tax Returns Article 25 Taxpayers must, in accordance with the laws and administrative regulations, and in keeping with the time limit and contents for filing Withholding agents must, in accordance with the laws and administrative regulations, or the time limit and contents for filing tax Article 26 Taxpayers and withholding agents may directly file tax returns or submit reporting schedules on the taxes withheld and remitted or Article 27 Where a taxpayer or withholding agent is unable to file tax returns or to submit reporting schedules on the taxes withheld and remitted Where the filing of the tax returns or submission of the reporting schedules prescribed in the preceding paragraph is postponed upon Chapter III Tax Collection Article 28 The tax authorities shall collect taxes in accordance with the laws and administrative regulations. They shall not collect, cease The amount of agricultural taxes payable shall be assessed in accordance with the laws and administrative regulations. Article 29 Except for tax authorities, tax officials and the entities and personnel entrusted by tax authorities in accordance with the law or Article 30 Withholding agents shall fulfill their obligations of withholding or collecting taxes in accordance with the laws and administrative When a withholding agent is withholding or collecting taxes in accordance with the law, the taxpayer shall not refuse to pay taxes. The tax authorities shall, in accordance with the relevant provisions, pay a handling fee to withholding agents for withholding or Article 31 A taxpayer or withholding agent shall pay or remit taxes within the time limit prescribed in the laws or administrative regulations, Where a taxpayer is unable to pay taxes within a prescribed time limit because of special difficulties, he may, upon approval of the Article 32 Where a taxpayer fails to pay taxes or a withholding agent fails to remit taxes within a prescribed time limit, the tax authority Article 33 A taxpayer may submit a written application for tax reduction or exemption to the tax authority in accordance with the laws and administrative Applications for tax reduction or exemption shall be examined and approved by the authorities designated for examination and approval Article 34 When a tax authority collects taxes, it must issue tax payment receipts to the taxpayers. A withholding agent shall, when withholding Article 35 Where a taxpayer is in any of the following circumstances, the tax authority shall have the right to assess the amount of taxes payable (1) accounting books are not required necessarily to be established in accordance with the laws and administrative regulations; (2) accounting books are required by the laws and administrative regulations to be established but have not been established; (3) a taxpayer destroys accounting books without authorization or refuses to provide information on tax payment; (4) although accounting books have been established, the accounting entries have not been entered in an appropriate manner or the information (5) a taxpayer who is obligated to pay taxes fails to go through tax filing procedures within a prescribed time limit and, after having (6) the taxation basis filed by a taxpayer is obviously much lower, and without reasonable ground. Specific procedures and methods for tax authorities to assess the amount of taxes payable shall be stipulated by the competent tax Article 36 The receipt or payment of charges or fees in business transactions between an enterprise (or institution or site engaged in production Article 37 Tax authority shall assess the amount of taxes payable by a taxpayer engaged in production or business operations who does not apply Article 38 Where a tax authority has grounds for deeming that a taxpayer engaged in production or business operations has any act of evading (1) notify in writing the banks or other financial institutions with which the taxpayer has opened an account to freeze the taxpayer’s (2) distrain or seal up the taxpayer’s taxable commodities, goods or other properties, the value of which is equivalent to the amount If the taxpayer makes the tax payment within the time limit as prescribed in the preceding paragraph, the tax authority must immediately The necessary lodgings and articles of an individual and his dependent family members to make a living shall not be within the scope Article 39 Where a taxpayer has made the tax payment within the time limit, but the tax authority fails to immediately release the preservative Article 40 Where a taxpayer engaged in production or business operations or a withholding agent fails to pay or remit taxes, or a tax payment (1) notify in writing the bank or other financial institution with which the taxpayer, withholding agent or tax payment guarantor has (2) distrain, seal up or sell by auction or sell off in accordance with the law the commodities, goods, or other properties of the taxpayer, At the time when the tax authority is adopting the mandatory measures, it shall adopt the relevant mandatory measures to collect the The necessary lodgings and articles of an individual and his dependent family members to make a living shall not be within the scope Article 41 The power to adopt the preservative measures of taxation or mandatory enforcement measures prescribed in Article 37 , 38 and 40 shall Article 42 Any of the tax authorities must adopt preservative measures of taxation or mandatory enforcement measures according to the legal authority Article 43 Where a tax authority abuses its powers and illegally adopts preservative measures of taxation or mandatory enforcement measures, Article 44 Where a taxpayer or his legal representative who has not paid the amount of taxes payable needs to leave China, he shall pay the taxes Article 45 When a tax authority is collecting taxes, the taxation shall have precedence over unsecured credits unless otherwise prescribed in Where a taxpayer has not paid the amount of taxes payable, and meanwhile he is imposed on a fine or confiscation of illegal proceeds Tax authorities shall regularly announce the circumstances of the unpaid amount of taxes payable by taxpayers. Article 46 Where a taxpayer has not paid the taxes payable but mortgages or pledges his properties, he shall state the fact of not paying the Article 47 When distraining commodities, goods or other properties, the tax authority must issue a receipt for the distrained items. When sealing Article 48 Where a taxpayer has the circumstance of merger or division, he shall report to the tax authority, and make a full payment of taxes Article 49 A taxpayer who has not paid a large amount of taxes payable shall report to the tax authority before he disposes of his immovable Article 50 Where a taxpayer who has not paid the taxes payable causes any loss to the State taxation due to his idleness in exercising his mature Where the tax authority exercises its rights of subrogation and rescission in accordance with the preceding paragraph, the taxpayer Article 51 Once the tax authority finds that a taxpayer has paid an amount of taxes in excess of the taxes payable, the authority shall immediately Article 52 Where a taxpayer or withholding agent fails to pay taxes or underpay taxes due to the fault of the tax authority, the tax authority Where a LAW OF THE PEOPLE’S REPUBLIC OF CHINA ON CHINESE-FOREIGN EQUITY JOINT VENTURES
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The Ministry of Foreign Trade and Economic Cooperation Circular of the Ministry of Foreign Trade and Economic Cooperation on Submission of Import and Export Plans for Enterprises with Foreign WaiJingMaoZiTongJinHanZi [2000] No.768 October 25, 2000 Ministries and commissions of the State Council,commissions (departments, bureaus) of Foreign Trade and Economic Cooperation of various In order to ensure the continuity and stability of the production in foreign-invested enterprises (FIEs), the following notice is I. Scope of the plans (1) import plans for goods under general quota and for goods the imported volume of which should be registered (including key industrial (2) import plan for electric and mechanic products imported by FIEs for investment or self use; (3) Export plan of FIEs for products under export licenses; (4) import and export plan of FIEs for poisonous chemical products. II. Guideline and requirement for the plan The authorities of foreign trade and economic co-operation shall formulate a complete plan according to the business scopes, production (1) For import of key industrial products by FIEs for manufacture of products for sale on the domestic market, chemical fertilizers should (2) Export plan a. Foreign-invested enterprises which are included in the annual export plan must be FIEs whose export scale has been approved by MOFTEC b. Products exported by FIEs must be self-manufactured products. c. Products of which the export quota are subject to the regime of public bidding, payment of fees or involuntary quota shall not be (3) Export and import plan for poisonous chemical products a. The import plans of poisonous chemical products in 2001 should be formulated according to the import of such products by FIEs from b. Export of poisonous chemical products shall continue to follow the Principles and Procedures for the Approval of Import of poisonous III. Requirement for the submission of the plans The Foreign Trade and Economic Co-operation authorities should submit their plans through the network system to the Foreign Investment For FIEs whose Chinese partner’s competent authority is a Ministry or a Commission under the State Council or China Offshore Petroleum IV. Date and place for the meeting on the regulation of import and export of FIEs shall be notified later. |
The Ministry of Foreign Trade and Economic Cooperation
2000-10-25
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The State Administration of Taxation Circular of the State Administration of Taxation on the Settlement for the Taxpayers Obtaining the False Special Invoice of Value-added GuoShuiFa [2000] No.187 November 16, 2000 It is reported recently that how to deal with the buyers receiving the false added-values tax special invoice drawn by the sellers The buyers should not be handled in name of tax-evading and defraud of export tax rebate if the real transaction occurs and the sellers If the buyers can obtain the legal and valid special invoice drawn by the anti-counterfeit taxation control system from the sellers If there is evidence that shows the buyers know the invoice is obtained illegally before receipts credit or exports tax rebate, the The Circular shall enter into force as of the date of issuance. |
The State Administration of Taxation
2000-11-16
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The State Economic and Trade Commission, the Ministry of Foreign Trade and Economic Cooperation, the General Administration of Customs Circular of the State Economic and Trade Commission, the Ministry of Foreign Trade and Economic Cooperation and the General Administration GuoJingMaoMaoYi [2000] No.570 June 16, 2000 The Economic and Trade Commission and Foreign Trade Committee of the provinces, autonomous regions, municipalities directly under With a view to implementing the Circular of the General Office of the State Council on Transmitting the Opinions of State Economic |
The State Economic and Trade Commission, the Ministry of Foreign Trade and Economic Cooperation, the General Administration
of Customs
2000-06-16
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The State Administration of Taxation Circular of the State Administration of Taxation on some Issues Concerning the Taxation of Enterprises with Foreign Investment in GuoShuiFa [1999] No.242 December 21, 1999 The state and local taxation bureaus of each province, autonomous region, municipalities directly under the Central Government and In order to regulate the administration of taxation, some issues concerning the taxation of enterprises with foreign investment in 1. Business and income tax should be counted on the basis of the price paid by the foreign buyer to the foreign enterprise, if an enterprise 2. Full and valid documents should be offered for labor charges paid by the above-mentioned enterprise with foreign investment such as This circular shall enter into force as of January 1, 2000. |
The State Administration of Taxation
1999-12-21
| Category | PUBLIC HEALTH AND MEDICINE | Organ of Promulgation | The State Council | Status of Effect | In Force |
| Date of Promulgation | 2000-01-04 | Effective Date | 2000-04-01 |
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Regulations on Supervision and Management to Medical Instruments |
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Chapter I General Principles
Chapter II Management of Medical Instruments
Chapter III Management to the production, business and Use of medical Instruments
Chapter IV Supervision of Medical Instruments
Chapter V Penalty Provisions
Chapter VI Supplementary Provisions
(Adopted at the 24th Meeting of the State Council on December 28, 1999. promulgated by Decree No. 276 the State Council of the People’s
Republic of China on January 4, 2000, and come into force as of the date April 1, 2000)
Chapter I General Principles
Article 1 These Regulations are formulated with a view to strengthening the supervision and management of medical instruments, guaranteeing
the safety and effectiveness of medical instruments, and protecting the human physical health and safety of life.
Article 2 Any unit or individual engaged in the research, manufacture, business operation, use, supervision and management of medical
instruments within the People’s Republic of China shall comply with these Regulations.
Article 3 The medical instruments in these Regulations mean instruments, equipment, apparatus, material and other articles, separately
or cooperatively, applied to human body, including the required software; the targeted functions by applying them to the surface
or inside of human body are not obtained by means of pharmacology, immunology or metabolism, but it’s likely that these means participate
and contribute to certain auxiliary functions; the use of them is intended to achieve such anticipative goals as follows:
(a) Prevention, diagnosis, treatment, custody and relief to disease;
(b) Diagnosis, treatment, custody, relief and compensation to injury or disability;
(c) Research, replacement and adjustment to dissection or physiological process;
(d) Gestation control.
Article 4 The medical supervision and management authority of the State Council is responsible for the national supervision and
management of medical instruments.
The medical supervision and management authorities under local people’s governments at or above county is
responsible for the supervision and management of medical instruments within their administrative regions respectively.
The medical supervision and management authority of the State Council shall coordinate with the management
department of economic complex under the State Council in carrying out and implementing state policies in medical instruments industry.
Article 5 The state adopts separate management for medical instruments.
The first category means those medical instruments whose safety and effectiveness may be adequately ensured
by ordinary management.
The second category means those medical instruments whose safety and effectiveness shall be controlled.
The third category means to the medical instruments whose safety and effectiveness must be strictly controlled,
which are used to be planted into human body, and be used to support and keep life and with potential danger to human body.
The categorized catalog of medical instruments shall be formulated, adjusted and publicized by the medical
supervision and management authority under the State Council, in accordance with the rules on medical instruments categorization,
in consultation with the health administrative authority of the State Council.
Article 6 The medical instruments with the aim of providing concrete metrological values by manufacture and use shall conform with the provisions
of Metrological Law. The detailed product catalog shall be formulated and publicized by the medical supervision and management authority
under the State Council in conjunction with the meteorological administrative authority of the State Council.
Chapter II Management of Medical Instruments
Article 7 The state encourages to develop new medical instruments. The new medical instruments mean brand-new varieties that haven’t
appeared on domestic market or whose safety, effectiveness and product mechanism haven’t been recognized at home.
The clinical tryout of new medical instruments belonging to the second or third category shall be conducted
after being approved in accordance with regulations of the medical supervision and management authority of the State Council.
The new medical instruments of which clinical tryout have been completed and having passed the expert appraisal
sponsored by the medical supervision and management authority of the State Council shall be approved and issued the new product certificates
by the medical supervision and management authority of the State Council.
Article 8 The state adopts registration system of product manufacture of medical instruments.
The production of first category medical instruments shall be examined and approved by the medical supervision
and management authority of municipal people’s government with districts, which then issues the registration certificates of product
manufacture.
The production of second category medical instruments shall be examined and approved by the medical supervision
and management authority of the people’s governments in provinces, autonomous regions or municipalities directly under central authority,
which then issue the registrations certificates of product manufacture.
The production of third category medical instruments shall be examined and approved by the medical supervision
and management authority of the State Council, which then issues the registration certificate of product manufacture.
For the manufacture of second or third category medical instruments, clinical verification shall be passed.
Article 9 The medical supervision and management authorities of the people’s governments in provinces, autonomous regions or municipalities
directly under central authority are responsible for the examination and approval of the clinical tryout or clinical verification
of the second category medical instruments within its own administrative domain. The medical supervision and management authority
of the State Council is responsible for the examination and approval of the clinical tryout or clinical verification of the third
category medical instruments. The clinical tryout or clinical verification shall be conducted at medical institution specified by
the medical supervision and management authorities of the people’s governments at or above provinces level. The medical institution
conducting clinical tryout or clinical verification shall conform to the regulations of the medical supervision and management authority
of the State Council.
The qualification of the medical institution to conduct clinical tryout or clinical verification shall be
determined by the medical supervision and management authority of the State Council in consultation with the health administrative
authority of the State Council.
Article 10 The medical institution may develop medical instruments according to its own clinical need, and use the same under direction
of practicing doctor within such institution.
The second category medical instruments developed by medical institution shall be reported to the medical
supervision and management authority of the people’s governments at or above provinces level for examination and approval; The third
category medical instruments developed by medical institution shall be reported to the medical supervision and management authority
of the State Council for examination and approval.
Article 11 For the first imported medical instruments, the importing unit shall submit the instructions, quality standards, inspection
methods and other relevant materials, the sample, and the documents evidencing the exporting country’s approval of the manufacture
and sales, of such medical instruments, and only after having been examined and approved and registered by the medical supervision
and management authority of the State Council and obtaining the registration certificate of importation may such unit apply to the
customs for fulfilling import formalities.
Article 12 The ones declaring registrated medical instruments shall present, the technical specifications, inspection report and
other relevant in accordance with the regulations of the medical supervision and management authority under the State Council.
The medical supervision and management authority under a municipal people’s government with districts shall
decide whether to grant a registration within 30 working days as from the date of accepting the application; if registration isn’t
granted, written reasons shall be given.
The medical supervision and management authority under the people’s governments in provinces, autonomous regions
or municipalities directly under central authority shall decide whether to grant a registration within 60 working days as from the
date of accepting the application; if registration isn’t granted, written reasons shall be given.
The medical supervision and management authority under the State Council shall decide whether to grant a registration
within 90 working days as from the date of accepting the application; if registration isn’t granted, written reasons shall be given.
Article 13 In the event of any change occurs to the contents of the product registration certificate of medical instruments, the
unit holding such certificate shall apply for modification procedures or re-registration within 30 days as from the date of occurrence
of such change.
Article 14 The validity period of the product registration certificate of medical instruments is 4 years. The unit holding such certificate
shall apply re-registration within the 6 months prior to the expiration of the product registration certificate.
If the cessation of production continues for over 2 years, the registration certificate of product manufacture
shall lose effect automatically.
Article 15 The manufacture of medical instruments shall conform to the state standards of medical instruments; in the absence of
state standards, they shall conform to industrial standards of medical instruments.
The state standards of medical instruments shall be formulated by the standardization administrative authority
under the State Council in conjunction with the medical supervision and management authority of the State Council. The industrial
standards of medical instruments shall be formulated by the medical supervision and management authority of the State Council.
Article 16 The instructions for use, labels and packages of medical instruments shall conform to relevant state standards or regulations.
Article 17 The serial number of the product registration certificate shall be indicated on the medical instruments and the outer
package thereof in accordance with regulations of the medical supervision and management authority of the State Council.
Article 18 The state adopts re-appraisal and washout systems in medical instruments. The detailed measures shall be formulated by
the medical supervision and management authority of the State Council in consultation with relevant departments of the State Council.
Chapter III Management to the production, business and Use of medical Instruments
Article 19 The enterprises manufacturing medical instruments shall conform to the following requirements:
(a) Having professional technical staff appropriate to the medical instruments manufactured;
(b) Having premises and environment for manufacture appropriate to the medical instruments manufactured;
(c) Having manufacture equipment appropriate to the medical instruments manufactured;
(d) Having institution or staff that conducts product quality inspection of the medical instruments manufactured, and inspection equipment.
Article 20 The enterprise running the first category medical instruments shall be reported for the record to the medical supervision
and management authority of the people’s government of province, autonomous region or municipality directly under central authority.
The enterprise running the second or the third category medical instruments shall be examined and approved
by the medical supervision and management authority of the people’s government of province, autonomous region or municipality directly
under central authority, which then issues the
The validity period of the
be formulated by the medical supervision and management authority of the State Council.
Article 21 Only after obtaining the registration certificate of product manufacture of medical instruments may the enterprise manufacturing
medical instruments start manufacturing the same.
Article 22 The state adopts mandatory safety verification system with respect to partial third category medical instruments. The
detailed product catalog shall be formulated by the medical supervision and management authority of the State Council in conjunction
with the quality and technology supervisory authority of the State Council.
Article 23 The enterprises dealing with medical instruments shall conform to the following requirements:
(a) Having premises and environment for business operation appropriate to the medical instruments dealt with;
(b) Having quality inspection staff appropriate to the medical instruments dealt with; and
(c) Having product after-sale servicing ability such as technical training and repair appropriate to the medical instruments dealt
with.
Article 24 The enterprise running the first category medical instruments shall be reported for the record to the medical supervision
and management authority of the people’s government of province, autonomous region or municipality directly under central authority.
The establishment of an enterprise dealing with the second or the third category medical instruments shall
be examined and approved by the medical supervision and management authority of the people’s government of province, autonomous region
or municipality directly under central authority, which then issues the
The validity period of the
be formulated by the medical supervision and management authority of the State Council.
Article 25 The medical supervision and management authority of the people’s government of province, autonomous region or municipality
directly under central authority shall decide whether to grant a license within 30 business days as from the date of accepting the
application for
Article 26 The enterprise dealing with medical instruments and the medical institution shall purchase certified medical instrument
from productive or commercial enterprise with
The enterprise dealing with medical instruments shall not trade in medical instruments that are unregistered,
without certificate of quality product, expired, loss of effect or washed out.
The medical institution shall not use medical instruments that are unregistered, without certificate of quality
product, expired, loss of effect or washed out.
Article 27 The medical institution shall not repeatedly use one-off use medical instruments; the used shall be destroyed in accordance
with relevant regulations of the state and be recorded.
Article 28 The state establishes quality accident report system of medical instruments and quality accident publicity system of medical
instruments. The detailed regulations shall be formulated by the medical supervision and management authority under the State Council
in conjunction with health and family planning administrative authorities under the State Council.
Chapter IV Supervision of Medical Instruments
Article 29 The medical supervision and management authority under the people’s government at or above county level shall appoint
supervisors of medical instruments. The supervisors of medical instruments are responsible for the supervision and inspection of
enterprises manufacturing or dealing with medical instruments and medical institutions within their administrative domain; when necessary,
they may, in accordance with regulations of the medical supervision and management authority of the State Council, draw samples and
require relevant information, and the unit or individual concerned shall not refuse or disguise. The supervisors are obliged to keep
the samples or information obtained in confidentiality.
Article 30 The state adopts qualification authentication system in inspection institutions of medical instruments. Only the inspection
institutions having been authenticated by the medical supervision and management authority of the State Council in conjunction with
the quality and technology supervisory authority of the State Council may perform inspection of medical instruments.
The inspection institution of medical instruments and its staff are obliged to keep the technical information
of the unit being inspected in confidentiality, and shall not engage or participate in the development, manufacture, business operation,
technical consulting and other activities of medical instruments in connection with the inspection.
Article 31 The medical supervision and management authority under local people’s government at or above county level may seal up
and seize the products and relevant materials that have resulted in quality accident of medical instrument or might result in quality
accident of medical instrument.
Article 32 For the medical instruments with safety and effectiveness unable to be guaranteed, the medical supervision and management
authority under the people’s government at or above province level shall cancel their product registration certificate. The medical
instruments with cancelled product registration certificate shall not be manufactured, sold or used, and for those having been manufactured
or imported, the medical supervision and management authority of local people’s government at county or above level is responsible
for supervision and disposition.
Article 33 The product registration implemented by the medical supervision and management authority under municipal people’s governments
with districts at or above county level in violation of provisions of this Regulations shall be rectified within given period ordered
by the medical supervision and management authority under the State Council; in the event of failure to make rectification upon expiry,
the product registration certificate of medical instruments illegally registered shall be cancelled and publicity shall be made.
Article 34 The advertisement of medical instruments shall be examined and approved by the medical supervision and management authority
under the people’s government at or above province level; without approval, no publishing, broadcasting, handing-out or posting is
allowed.
The contents of the advertisement of medical instruments shall be based on the instructions for use approved
by the medical supervision and management authority of the State Council or the medical supervision and management authority of the
people’s governments in provinces, autonomous regions or municipalities directly under central authority.
Chapter V Penalty Provisions
Article 35 For an enterprise manufacturing without registration certificate of product manufacture of medical instruments in violation
of provisions of this Regulations, the medical supervision and management authority of people’s government at or above county level
shall order the cessation of production, and confiscate the illegally manufactured products and illegal income, and if the illegal
income exceeds RMB 10,000 Yuan, a fine of not less than 3 times and not more than 5 times the illegal income shall be imposed together;
if there is no illegal income or the illegal income is less than RMB 10,000 Yuan, a fine of not less than RMB 10,000 Yuan and not
more than RMB 30,000 Yuan shall be imposed together; if the circumstances are serious, the medical supervision and management authority
of the people’s government in a province, autonomous region or municipality directly under central authority shall cancel its
Article 36 For the enterprise manufacturing the second or the third category medical instruments without
county level shall order cessation of production, and confiscate the illegally manufactured products and illegal income, and if the
illegal income exceeds RMB 10,000 Yuan, a fine of not less than 3 times and not more than 5 times the illegal income shall be imposed
together; if there is no illegal income or the illegal income is less than RMB 10,000 Yuan, a fine of not less than RMB 10,000 Yuan
and not more than RMB 30,000 Yuan shall be imposed together; if the matter constitutes a criminal offence, criminal liability shall
be pursued according to law.
Article 37 For the enterprise manufacturing medical instruments not conforming to the state standards or industrial standards of
medical instruments in violation of provisions of this Regulations, the medical supervision and management authority of people’s
government at or above county level shall impose warning, and order cessation of production, and confiscate the illegally manufactured
products and illegal income, and if the illegal income exceeds RMB 5,000 Yuan, a fine of not less than 2 times and not more than
5 times the illegal income shall be imposed together; if there is no illegal income or the illegal income is less than RMB 5,000
Yuan, a fine of not less than RMB 5,000 Yuan and not more than RMB 20,000 Yuan shall be imposed together; if the circumstances are
serious, the original issuing authority shall cancel its registration certificate of product manufacture; if the matter constitutes
a criminal offence, criminal liability shall be pursued according to law.
Article 38 For the enterprise manufacturing the second or the third category medical instruments without
county level shall order cessation of dealing, confiscate the illegally manufactured products and illegal income, and if the illegal
income exceeds RMB 5,000 Yuan, a fine of not less than 2 times and not more than 5 times the illegal income shall be imposed together;
if there is no illegal income or the illegal income is less than RMB 5,000 Yuan, a fine of not less than RMB 5,000 Yuan and not more
than RMB 20,000 Yuan shall be imposed together; if the matter constitutes a criminal offence, criminal liability shall be pursued
according to law.
Article 39 For the enterprise dealing with medical instruments that are without product registration certificate, without certificate
of quality product, expired, loss of effect or washed out, or purchasing medical instruments from enterprise without
or above level shall order cessation of production, confiscate the illegally manufactured products and illegal income, and if the
illegal income exceeds RMB 5,000 Yuan, a fine of not less than 2 times and not more than 5 times the illegal income shall be imposed
together; if there is no illegal income or the illegal income is less than RMB 5,000 Yuan, a fine of not less than RMB 5,000 Yuan
and not more than RMB 20,000 Yuan shall be imposed together; if the circumstances are serious, the original issuing authority shall
cancel its
Article 40 For the enterprise cheating its product registration certificate of medical instruments by furnishing false certificate,
document, information or sample or by other deceitful means at the time of applying for registration of medical instruments, in violation
of provisions of this Regulations, the original issuing authority shall cancel its product registration certificate, not accept its
product registration applications within two years, and impose a fine of not less than RMB 10,000 Yuan and not more than RMB 30,000
Yuan; for products having been manufactured, shall confiscate the illegally manufactured products and illegal income, and if the
illegal income exceeds RMB 10,000 Yuan, a fine of not less than 3 times and not more than 5 times the illegal income shall be imposed
together; if there is no illegal income or the illegal income is less than RMB 10,000 Yuan, a fine of not less than RMB 10,000 Yuan
and not more than RMB 30,000 Yuan shall be imposed together; if the matter constitutes a criminal offence, criminal liability shall
be pursued according to law.
Article 41 For violation of provisions of Article 34 of these Regulations with respect to advertising of medical instruments, the
administrative authority for industry and commerce shall deal with it in accordance with relevant state laws and regulations.
Article 42 For medical institution using medical instruments that are without product registration certificate, without certificate
of quality product, expired, loss of effect or washed out, or purchasing medical instruments from enterprise without
or above level shall order rectification, impose warning, confiscate the illegally used products and illegal income, and if the illegal
income exceeds RMB 5,000 Yuan, a fine of not less than 2 times and not more than 5 times the illegal income shall be imposed together;
if there is no illegal income or the illegal income is less than RMB 5,000 Yuan, a fine of not less than RMB 5,000 Yuan and not more
than RMB 20,000 Yuan shall be imposed together; the chief responsible officer and other person with direct liability shall be imposed
disciplinary punishment; if the matter constitutes a criminal offence, criminal liability shall be pursued according to law.
Article 43 For medical institution repeatedly using one-off use medical instruments or failing to destroy the medical instruments
that shall be destroyed, in violation of provisions of these Regulations, the medical supervision and management authority of people’s
government at or above county level shall order rectification and impose warning, and may impose a fine of not less than RMB 5,000
Yuan and not more than RMB 30,000 Yuan shall be imposed; the chief responsible officer and other person with direct liability shall
be imposed disciplinary punishment; if the matter constitutes a criminal offence, criminal liability shall be pursued according to
law.
Article 44 For medical institution in clinical tryout or clinical verification of medical instruments providing false report in violation
of provisions of these Regulations, the medical supervision and management au