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National Commission On The Amendment Of The Foreign Doctors To Practise In The Short-Term Interim Measures Such As The 8 Rules Of Decision

Original Language Title: 国家卫生计生委关于修改《外国医师来华短期行医暂行管理办法》等8件部门规章的决定

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  In order to advance the reform of administrative examination and approval system and transformation of government functions according to law, according to the State Department to cancel, decentralization and adjustment of administrative approval items decision, I clean up the related departmental rules.

After cleaning, the parts of the following regulations be amended.

First, the foreign doctors to practise in the short-term interim measures for the administration of (a) in the way of "Ministry of health" uniform is amended as: "the State health and family planning", the words "administrative departments of public health," unity is amended as: "family planning administrative departments for public health." (B) article 17th is amended as: "foreign medical groups to practise in the short-term, by invitation or districts, where the cooperation of municipal health family planning administrative departments in accordance with the relevant provisions of the measures for approval. "Second, the measures for the administration of blood stations (a) in the way of" Ministry of health "uniform is amended as:" the State health and family planning ", the words" administrative departments of public health, "unity is amended as:" family planning administrative departments for public health. " Investee (b) modified the article 27th to: "blood blood bank staff should be job training and assessment. Blood stations shall meet the job qualifications of the staff regulations, and job training and examinations before they can post. Investee "blood center staff shall receive not less than 75 hours a year post continuing education. Investee "provincial family planning administrative departments for public health shall work out blood bank staff training standards or guidelines, and to blood on the job training, assessment to guide and supervise the work. "The investee (c) modify the 41st to:" for clinical, research, or special needs need to be redeployed from other provinces, autonomous regions and municipalities directly under the blood, by the provincial family planning administrative departments of health under implementation. Investee "for humanitarian and life-saving purposes, you need to provide blood to the medical institutions outside China, and specific blood components shall be in strict accordance with the relevant rules of procedure. "The investee (d) 61st article the 13th amendment as follows:" without authorization, provisioning and other provinces, autonomous regions and municipalities directly under the blood.

"Third, the administrative measures for apheresis plasma (a) in the way of" Ministry of health "uniform is amended as:" the State health and family planning ", the words" administrative departments of public health, "unity is amended as:" family planning administrative departments for public health. " (B) to modify the article 34th to: "the collection of plasma to key staff positions should be training and assessment. Apheresis plasma station key provisions of staff should meet the job qualifications, and job training and examinations before they can post.

Investee "Apheresis plasma station staff should receive not less than 75 hours a year post continuing education. "Provincial family planning administrative departments for public health shall work out single collection of plasma station staff training standards or guidelines, and for apheresis plasma station to carry out job training, assessment to guide and supervise the work.

"And the medical diagnostic management regulations by deleting the 27th second, third and fourth paragraphs. Five, the aesthetic and medical services regulations (a) to modify the article 12th to: "not attending in the conditions stipulated in this article 11th practitioners may be guided by the attending physician in the medical beauty clinic technical services.

"(Ii) by deleting article 14th, 25th.

Six of the implementing rules of the regulations, the public health management (a) the detailed rules for the implementation of the "Ministry of health" uniform is amended as: "the State health and family planning", the words "administrative departments of public health," unity is amended as: "family planning administrative departments for public health."

(B) article 22nd is revised as follows: "States in addition to parks, sports stadiums, public transport public implementation of hygiene license management.

"Public places after obtaining a business license issued by the Administrative Department for industry and commerce shall also be in accordance with the provisions applied to the family planning administrative departments of local people's Governments at or above the county level health sanitation license, to operate. "The scope of public health surveillance by provinces, autonomous regions and municipalities directly under the family planning administrative departments of health under publication. "Seven, the management of disinfection (a) in the way of" Ministry of health "uniform is amended as:" the State health and family planning ", the words" administrative departments of public health, "unity is amended as:" family planning administrative departments for public health. " Investee (b) modified the 20th to: "disinfectants, disinfection equipment and hygiene products production enterprises after obtaining a business license issued by the Administrative Department for industry and commerce, also issued by the provincial family planning administrative departments for public health shall be obtained health permits, before engaging in the production of disinfection products. "The investee (c) 22nd article is revised as follows:" health licensed production of disinfection products enterprises project into disinfectants, disinfection equipment and health products. "The investee (d) by deleting article 23rd in the" review once a year. "The investee (v) by deleting the 26th and 27th. Investee (vi) modify the 28th to: "production, import new materials, new technology and new sterilization principle of production of disinfectants and disinfection devices (hereinafter referred to as the new product) should be in accordance with the regulations issued by the State Health Commission health permit. Investee "production, import new product of disinfectants and disinfection resistance of equipment and sanitation supplies (bacteriostatic) preparation, production and import enterprises should be in accordance with the relevant provisions of the health and safety assessment, meet the sanitary standards and specifications. Products listed to the hygienic safety evaluation report to the provincial family planning administrative departments for the record, the record shall, in accordance with the requirements to provide information. "The investee (VII) modify the 29th to:" manufacturer to apply for a new product health permit, responsibility in China applied for import of new disinfection product health permit, shall, in accordance with the National Health Commission new health administration regulations require disinfection products, to apply to the State Health Commission. National health family planning Commission shall, in accordance with the relevant laws and regulations, make a decision on whether to approve it. "The investee" approved by the State Health Commission on new product and issue health permit, approval number format: new side effect: unknown Wei Xiao (year) XXXX number. Is not granted, it shall explain the reasons. "The investee (h) by deleting article 30th. Investee (IX) article 31st is amended as: "new product health permit is valid for four years. "The investee (ten) in the 31st after an article shall be added:" the State Sanitary Commission bulletin on a regular basis to obtain an administrative authorization of new disinfection products approved. Date of announcement to include announcements of similar products not on the basis of the new disinfection products for health administration. "The investee (11) will be the 32nd article II be amended as:" (b) the products hygienic safety evaluation report or copy of new product health permit. "The investee (12) article 34th is amended as:" prohibition of the production and operation of sterilization of the following products: (a) no manufacturer approved health permit or new product health permit documents; (b) hygienic safety evaluation of the product is not qualified or do not meet the requirements of hygienic quality of the product. "The investee (13), by deleting the articles 35th and 36th of the fifth. Investee (14) 40th is revised as follows: "any of the following circumstances, National Commission of health of health permit review new product: (a) the product raw materials, principles of sterilization and production challenges, (ii) product safety and efficacy questioned. "The investee (15) 41st is amended as:" new product health permit holder shall from the date of receiving notice from the National Health Commission to re-examine in the 30th, in accordance with the notification of the requirement to submit materials. Time did not submit the relevant materials, as a waiver review, the State Health Commission can write-off the product health permit. "The investee (16) 42nd is amended as:" the State Health Commission from the date it received to review all the materials needed in the 30th, review decision should be made. Any of the following circumstances, cancellation of product health permit: (a) the product raw materials, production process does not meet the principles of sterilization and use of new materials, new technology and new sterilization principle of production of disinfectants and disinfection devices reference; (b) disinfection effect of product safety, does not meet requirements. "The investee (17) 47th is amended as:" disinfection products production and operation in violation of this article 31st, 32nd article, health family planning administrative departments at and above the county level shall be ordered to rectify, can be fined a maximum of 5000 Yuan and cause outbreaks of infectious diseases, may be fined not more than 5000 Yuan more than 20000 Yuan.

"The investee (18) by deleting article 48th. Eight, the human infection of highly pathogenic Microbe laboratories and experimental activities in biosafety regulation on approval (a) in the way of "Ministry of health" uniform is amended as: "the State health and family planning", the words "administrative departments of public health," unity is amended as: "family planning administrative departments for public health." Investee (ii) 18th is amended as: "the lab report or receive research projects associated with highly pathogenic microorganisms shall conform to research and bio-safety requirements, with appropriate biosafety levels. In accordance with the approach set forth in 12th and 13th, should be by the national health research projects involving activities that Commission approval, Undertaker project results should be reported to the State Health Commission; research projects involving experiments should be approved by the provincial family planning administrative departments for public health activities, undertake project results should be reported to the provincial health Administrative Department of planning. Investee "after a scientific research project undertaken by the laboratory activity, shall be in accordance with these measures the 14th, 15th and 16th articles for approval. "The investee (c) by deleting article 19th. Investee (d) deletion of annex 3.

Investee in addition, related Department regulations corresponding adjustments in the order according to the provisions of this decision. This decision shall come into force as of the date of.