is an international industry organization composed of the world's major medical device manufacturers and exporters. according to reports, the secretary general of the agency pointed out at an industry international conference held not long ago that a large global circulation market for medical devices has been formed. in order to strengthen the integration of international medical device supervision, it is necessary to establish a unified international standard for medical devices (including their outer packaging materials). at present, the primary task is to revise the international industry formulated many years ago standards. the performance requirements of aseptic barrier and waterproof, high temperature resistance and other special requirements of the old version of iso13485 are out of date now, so it is urgent to improve the standard.
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