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The Regulatory Landscapes for Medical Device Approval in China and Hong Kong

This article was originally published in SRA

Executive Summary

The regulatory landscape for medical devices in China is shifting constantly as the country presses on with efforts to reform its rules for healthcare products. China’s original medical device regulations were issued in 2000, but have been deemed insufficient for current needs.

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The Regulatory Landscapes for Medical Device Approval in China and Hong Kong

The regulatory landscape for medical devices in China is shifting constantly as the country presses on with efforts to reform its rules for healthcare products. China’s original medical device regulations were issued in 2000, but have been deemed insufficient for current needs.

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