The national health and family planning commission for the third class medical technology clinical application access about the work of examination and approval 
 
 
The 2015-07-02 national health and population and family planning commission of the People's Republic of China
 
 
The medical hair [2015] no. 71 

Provinces, autonomous regions and municipalities directly under the central government health and family planning commission, the xinjiang production and construction corps health bureau:
 
    To implement the reform of the system of administrative examination and approval of the state council, according to the state council for the decision of the non-executive licensing examination and approval matters "(guo fa [2015] 27), by commission decided to cancel the third class medical technology admittance of clinical application of examination and approval. By commission is in accordance with the "new, decentralization, as well as the combination of the pipes, optimize service" and the principle of "open, transparent and supervise" the policy of revision of "medical technology clinical practice management method". Join smoothly in order to ensure the medical technology clinical practice management, an orderly transition to guarantee medical quality and safety, in "medical technology clinical practice management method" revision completed before, now medical technology clinical practice management related work order is as follows:
 
    One, according to the state council "about the cancellation of non-executive permit the decision of the examination and approval matters", cancel the third class medical technology admittance of clinical application of examination and approval.
 
    Second, ban on clinical application of medical institutions, security, effectiveness of major problems medical technology (such as the pituitary gland alcohol for the treatment of damaged intractable pain), or major ethical problems (such as cloning technology, surrogacy technology), or the family planning administrative department of public health's ban on clinical application of medical technology, such as body YanChangShu except medical purposes), was eliminated and the clinical medical technology (such as corneal radial incision operation).
 
    Involves the use of drugs, medical devices and related products with similar attributes, such as preparation of medical technology, in medicine, medical apparatus and instruments or related products with similar properties, preparation and so on without the approval of the food and drug administration listed before, medical institutions may not engage in clinical application.
 
    Three, to the safety, efficacy precise, but the technology is difficult, high risk and the service ability of medical institutions, personnel level have higher requirements, need qualification; Or there are significant ethical risk, need strict management of medical technology, a medical institution shall limit the clinical application. The limit of clinical application of medical technology (2015 edition) "see attachment.
 
    Four, to carry out the limit of clinical application of medical technology (2015 edition) "in the column of medical technology, and through the third class medical technology clinical application for examination and approval of the ministry of health medical institutions, issued by the" practice license of medical institution "of the family planning administrative department of public health in the" practice license of medical institution "copy" remarks "column, and to the family planning administrative department of public health at the provincial level for the record.
 
    Intends to develop the new restrictions on clinical application of medical technology (2015 edition) "among the clinical application of medical technology, medical institutions shall, in accordance with the related medical technology clinical practice management by commission had issued by specification, assessed by the self control in conformity with the conditions stipulated, in accordance with the procedures for the record.
 
    Five, cancel the third class medical technology clinical application access after the examination and approval, medical technology clinical application and management of medical institutions shall bear the main responsibility. All kinds of medical institutions at all levels shall, in accordance with the "medical technology clinical practice management method" (who d ZhengFa [2009] no. 18) requirements, enhance the consciousness of the main body responsibility, establish and improve medical technology clinical practice management system, according to the grading management requirements for physicians in surgery authorization and dynamic management, establish and perfect the system of health technology assessment and management of archives.
 
    Six, according to the responsibility to strengthen the family planning administrative department of public health at all levels of medical institutions within their respective jurisdictions medical technology clinical supervision. Provincial family planning administrative departments for public health shall from the date of this notice issued, comprehensive clean up of the clinical application of medical technology within their respective jurisdictions; To establish the limit the clinical application of medical technology (2015 edition) "among the medical technology clinical application for record and publicity system, accept social supervision; Study to establish medical technology quality control and evaluation system as well as the clinical application of clinical application of standardization training system of medical treatment, medical treatment of medical institutions and the source of clinical application of credit rating; Make full use of information technology to strengthen supervision.
 
    Not according to requirements of this circular, the medical institution for the record, or to carry out the clinical application of medical technology, by the family planning administrative departments of public health in accordance with the "regulations on the administration of medical institutions" article 47 and "medical technology clinical practice management method" the provisions of article 50 to give punishment.
 
    Eight, laws and regulations have been set up administrative licensing medical technology, in accordance with the relevant provisions. Develop new technology of medical clinical research, according to the clinical research management of the relevant provisions.
 
    Nine, provincial family planning administrative department of public health under the state council shall, in accordance with the spirit of reform of administrative examination and approval and the related work deployment, the cancellation of the second category of medical technology non-executive permit approval measures to strengthen the supervision of matter later after work, to ensure the medical quality and patient safety.
 
    Ten, all the family planning administrative department of public health at the provincial level may, in accordance with this notice requirement to develop specific management measures, and on December 31, 2015 will cancel the third class medical technology admittance of clinical application of strengthen the regulation of matter later after examination and approval of relevant work situation reported by medical hospital authority.
 
    Eleven, released on May 22, 2009, the first batch of "allows the clinical application of the third class medical technology catalogue shall be repealed simultaneously.
 
    Touch: medical hospital authority jean-marclacape, xu-dong ma
 
    Contact phone: 010-68792793
 
    Fax: 010-68792067
 
    Attachment: limit the clinical application of medical technology (2015 edition). Doc 

The national health and family planning commission
On June 29, 2015