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

(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 T

he 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

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