China proposes simpler medical-device re-registration rules

04/8/2013 | Clinica (subscription required)

The China Food and Drug Administration has proposed reducing the amount of information companies must submit to re-register medical products when no changes exist that would affect safety or efficacy. Certain applications would require no technical review, but applications involving significant changes that might affect product safety and efficacy would require a new product registration. The agency has also proposed a system to expedite approval of certain innovative medical devices, but it would apply only for devices made by companies licensed in China.

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