Medical Devices
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Brazil’s Anvisa : Good Manufacturing Practice Certification for Medical Devices in Brazil
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China’s NMPA Guideline No. 101: Registration of Rare Disease Control Medical Devices
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Guidance for Eval of (AI) Assisted Systems
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Marketing Application – Home use MD for Diagnostic
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Mexico Good Manufacturing Practices (GMP) for Medical Devices
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Ministerial Ordinance 179: Good Manufacturing Practices for Drugs
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Ministerial Ordinance on Good Clinical Practice for Drugs
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PFSB No. 1121-15: Applications for Marketing Approval of In Vitro Diagnostics
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PMDA Guidelines: Clinical Study Data on Medical Devices from Foreign Clinical Studies in Japan
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