医疗器械注册新法规是什么?

如题所述

The China Food and Drug Administration (CFDA) has been actively expanding and updating its regulatory process for medical devices. In 2013, CFDA proposed a special review process intended to streamline medical device approvals for qualified applicants. This proposal of China medical device regulations, the Medical Device Supervision and Regulation, included changes to the supplementary review process designed to lessen the burden of the medical device license re-registration process, and also included plans to improve recalls and adverse event reporting.
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