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  • The state administration of food and drug administration promulgated the measures for the administration of medical devices standards
  • Release time： 2017-6-21　Clicks：3923　
  • On April 26, the state administration of food and drug administration issued the "standard management measures for medical devices" on its website, which will take effect on July 1, 2017. The methods of the management standardization of medical instrument to guide our country work, specification standard system revision, promote the implementation and promotion, improve the quality of medical apparatus and instruments etc. Play a positive role.
    Method revision background
    In 2002, the former national drug administration (fda) issued the standard management method for medical devices (trial) (original bureau order no. 31). With the continuous development of medical equipment standardization work, the original national drug administration was established in 2010 to form the management of medical instrument standard professional institutions, to further strengthen the standard of organization and management for medical equipment, medical equipment standard management system change.
    In June 2014, the state council promulgated the regulations on the supervision and administration of medical devices (state council order no. 650) (hereinafter referred to as the regulations), cancel the registration product standards and clarify the legal status of product technical requirement, changed the original medical equipment national standards, industry standards and registration of product standards level 3 standard system, medical devices standards system be changed accordingly.
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