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L airport line 1

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Beijing launched medical devices regulation look back

2015年04月22日

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Beijing launched medical devices regulation "look back" 
 
 
Source: xinhua health 

 

 

    On April 21 xinhua health messages (YanShan) on April 16, to consolidate the city's medical devices "five regulation" special operation work, the Beijing municipal food and drug administration to start the medical equipment throughout the city "look back", to the city's medical equipment the risk of hidden dangers, unqualified products and related enterprises to carry out rectification, verification complaints to report a case, investigate the violation behavior, to establish a perfect system of mechanism.
 
    It is reported, "look back" work will focus on implementing 7 working content, view the risk hidden dangers rectification implementation. Including in medical equipment production risk hidden danger "look back" : increase the intensity of flight check of the medical device manufacturing enterprise, carry out the key link, key varieties, supervision and examination of the key enterprises. Second, to carry out the use of medical devices, in vitro diagnostic reagents production management link, condoms and experiential marketing management link, plant (dielectric) into the high-risk products business risks, such as inspection work.
 
    , also will check the condom production situation, check the unqualified products and related enterprise reformed, verification complaints to report, investigate violation behavior, build system of perfect mechanism, social and medical device regulatory work.
 
    In addition, the Beijing municipal food drug administration combined with the characteristics of Beijing, on the national food administration of drug safety plan, check list three key contents: one is built against the illegal sales of medical equipment comprehensive management coordination mechanism, to jurisdiction glasses mall, store, residential areas, station, street, overpasses, underground passage, night markets, shopping malls, schools around the jewelry store, condom distribution market, small commodity wholesale market, the villages and towns of rural market as the key areas, such as a trawl screening, regular inspections and other dynamic supervision, to unlicensed operation and beyond operation and unlicensed products such as illegal act in accordance with the law, serious processing.
 
    2 it is to work closely with area of industry and commerce, health, family planning department, in accordance with the responsibility to carry out joint management work. Found the experience shop to issue without the examination and approval of medical apparatus and instruments product publicity materials, diagnosis and treatment of illegal conduct will be clues timely notification of the ministry of commerce and industry and family planning department of public health; Found the experience shop business activities, to trace the legitimacy of its operation behavior and the legitimacy of the products. Continuously carry out contact lenses, condoms and other products terminal market management responsibility, admission requirement market managers review operator qualification is legal, regular inspection on entry operator's management behavior; Found that the market has not obtained the license or registration certificate for the sale of medical devices shall timely stop, and immediately report the local food and drug regulatory authorities.
 
    Three is to the illegal business behavior of decorative color flat contact lenses, especially the illegal business behavior of merchants vendors, investigate the relevant cases, destroyed to produce black sites, illegal enterprise production and business operation license revoked, exposure of typical cases and punish the illegal molecules, to establish a long-term supervision mechanism, form a normative and orderly management order.
 
 
 
The original link: http://www.jkb.com.cn/news/industryNews/2015/0421/367198.html