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医疗器械监督管理条例 Regulations on Supervision and Management to Medical Instruments

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(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)
颁布日期:20000104  实施日期:20000401  颁布单位:国务院

  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 (License for Enterprise Manufacturing Medical Instruments ). In the absence of the (License for Enterprise Manufacturing Medical Instruments ), the administrative authority for industry and commerce shall not issue business license.

  The validity period of the (License for Enterprise Manufacturing Medical Instruments ) is 5 years, and upon the expiration thereof such license shall be re-examined and issued. The detailed regulations shall be shall 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 (License for Enterprise Dealing with Medical Instruments ). In the absence of the (License for Enterprise Dealing with Medical Instruments ), the administrative authority for industry and commerce shall not issue business license.

  The validity period of the (License for Enterprise Dealing with Medical Instruments ) is 5 years, and upon the expiration thereof such license shall be re-examined and issued. The detailed regulations shall be shall 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 (License for Enterprise Manufacturing Medical Instruments) or (License for Enterprise Dealing with Medical Instruments); if license isn't granted, written reasons shall be given.

  Article 26 The enterprise dealing with medical instruments and the medical institution shall purchase certified medical instrument from productive or commercial enterprise with (License for Enterprise Manufacturing Medical Instruments) or (License for Enterprise Dealing with Medical Instruments ) and inspect certificate of quality product.

  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 (License for Enterprise Manufacturing Medical Instruments); if the matter constitutes a criminal offence, criminal liability shall be pursued according to law.

  Article 36 For the enterprise manufacturing the second or the third category medical instruments without (License for Enterprise Manufacturing 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 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 (License for Enterprise Dealing with 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 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 (License for Enterprise Manufacturing Medical Instruments) or (License for Enterprise Dealing with Medical Instruments) in violation of provisions of this Regulations, the medical supervision and management authority of people's government at county 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 (License for Enterprise Dealing with Medical Instruments); if the matter constitutes a criminal offence, criminal liability shall be pursued according to law.

  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 (License for Enterprise Manufacturing Medical Instruments) or (License for Enterprise Dealing with Medical Instruments) in violation of provisions of this Regulations, the medical supervision and management authority of people's government at county 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 authority of the people's governments at or above provinces shall order rectification and impose warning, and may impose a fine of not less than RMB 10,000 Yuan and not more than RMB 30,000 Yuan shall be imposed; if the circumstances are serious, the qualification in clinical tryout or clinical verification of medical instruments shall be cancelled, and 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 45 For inspection institution of medical instruments and its staff engaged or participating in the development, manufacture, business operation or technical consulting of medical instruments in connection with the inspection or issuing false inspection report, in violation of provisions of these Regulations, the medical supervision and management authority of provincial or above people's government shall order rectification, impose warning and a fine of not less than RMB 10,000 Yuan and not more than RMB 30,000 Yuan shall be imposed; if the circumstances are serious, the medical supervision and management authority under the State Council shall cancel the inspection qualification of such inspection institution, and 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 46 If the supervisory and management personnel abusing authority, practicing grafts or derelict in duties, in violation of provisions of these Regulations; if it constitutes a criminal offence, criminal liability shall be pursued according to law; if not constitutes a criminal offence, administrative punishment shall be imposed according to law.

  Chapter VI Supplementary Provisions

  Article 47 The regulations on management of non-profit conception medical instruments shall be formulated separately by the medical supervision and management authority of the State Council in conjunction with relevant departments of the State Council.

  Article 48 These Regulations shall take effect as from April 1, 2000.

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