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Home » Hainan urgent device program underway, but complications await unwary device makers
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Hainan urgent device program underway, but complications await unwary device makers

Sep. 14, 2020
By Mark McCarty
China’s provincial government for Hainan Province has two sets of medical devices going through the urgent medical device needs program, but leveraging this program for regulatory approval in China is still no small undertaking. One complication is that any real-world evidence gathered in Hainan might not suffice for nationwide regulatory approval, but patient recruitment is also difficult.
BioWorld MedTech Regulatory Asia-Pacific China NMPA

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