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

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　　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 mu

nicipality 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 o

f 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

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