China Medical Device
Showing 1–16 of 19 results
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China’s NMPA Decree No. 1 – Annex 3: Guideline on Medical Device Adverse Event Monitoring Scope (Draft)
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China’s NMPA Decree No. 1 – Annex 7: Guideline on Focus Points when Monitoring Medical Device Adverse Events (Draft)
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China’s NMPA Decree No. 101: Regulations for The Administration of Overseas Inspection of Pharmaceutical & Medical Devices
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China’s NMPA Decree No. 131: Announcement on Using Chinese Name for Registrant or File Submitter of Imported Medical Devices
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China’s NMPA Decree No. 6: Guideline on the Design of Clinical Trials for Medical Devices
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China’s NMPA Decree No. 6: Regulation on Instructions for Use and Labels of Medical Devices
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China’s NMPA DECREE NO. 7 : Measures for Supervision and Administration of Medical Device Production
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China’s NMPA Decree No. 83: Innovative Medical Device Special Approval Procedure
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China’s NMPA Guideline No. 101: Registration of Rare Disease Control Medical Devices
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China’s NMPA” Guideline for Technical Review of Medical Device Software Registration
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China’s NMPA: Announcement on Record Filling of Medical Device Master Files
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China’s NMPA: Guideline for Clinical Trials of In Vitro Diagnostic Reagents (Draft)
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Guideline for Comparing the Same Variety of In-Vitro Diagnostic Reagents Exempted from Clinical Trials (Draft)
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Japan’s PMDA: C-Reactive Protein Assay Kit Registration Technical Review Guideline
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NMPA Guideline: Clinical Trial of Orthokeratology Rigid Gas Permeable (RGP) Contact Lenses in China
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NMPA: Guidelines on Registration of Rare Disease Control Medical Devices
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