software
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China’s NMPA” Guideline for Technical Review of Medical Device Software Registration
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PMDA Guideline: Conditional Early Approval System for Innovative Medical Device Products (Fast-Break Scheme) in Japan
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PMDA Guidline: Applications for Marketing Approval related to the Handling of Medical Device Software in Japan
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PSEHB No.0201: Applications for Marketing Approval related to the Period of Transitional Measures with respect to the Handling of Medical Device Software
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