Enterprises to increase the supervision of medical devices, recently, Luoyang City, Henan Province,digital thermometer Food and Drug Administration to take four measures to strengthen the administrative licensing of medical equipment enterprises and regulatory inspection.
First, strictly control market access. Accordance with the "medical equipment enterprises in Henan site inspection and acceptance standards" inspection and acceptance by one of the enterprises,clinical thermometer organizations focus on the responsible persons closed book test, rejected item has failed or has scored an average score of less than 80% items, determined not to pass.
Second is to strengthen the routine supervision and inspection. Improve the regulation of its daily supervision of the file,clinical thermometer so that "a business a file." Variety of high-risk enterprises and provincial regulatory product management business, the implementation of spot checks from time to time. Since 2010, 289 enterprises were checked, digital blood pressure monitor coverage of 95%. Key provincial regulators raided 83 times enterprise product management, coverage of 100%.
Third, in special campaigns. Has carried out special inspections of contact lenses, disposable sterile medical equipment enterprises special inspection, the third special inspection of medical equipment enterprises and so on. Check the soundness of business regulations and be carried out, the legality of purchasing and marketing channels, purchase and sale records sound, whether over the scope of operation or reduce operating and storage conditions, the availability of unauthorized changes to the management, storage spaces, quality managers, etc., severely punished without a "Medical Device Distribution Enterprise License" or illegal business over the extent permitted medical device behavior.
Fourth, explore the establishment of medical equipment enterprises delisting mechanism, the 11 no longer meets the operating conditions of enterprises, according to cancel the license.