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China's proposed regulatory scheme sets 45-day turnaround time for product decisions.

This article was originally published in The Gray Sheet

Executive Summary

CHINA'S PROPOSED MEDICAL DEVICE REGULATORY FRAMEWORK would provide for approval decisions within 45 days of processing registration applications from Chinese or offshore manufacturers, according to a "Guide to Product Registration and Advertisement Examination of Medical Devices" issued by the State Pharmaceutical Administration of China (SPAC). The regulatory plan must be approved by China's State Council before implementation can occur.
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