China

Showing 17–29 of 29 results

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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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  China’s NMPA: List of the First Batch of Rare Diseases

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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 Order No.82, 2020: the Issuance of Working Procedures for Review of Breakthrough Therapies in China

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  NMPA Technical Guidelines: Application of Phase I Clinical Trials of New Drugs in China

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  NMPA: Guidance for Clinical Evaluation of Proton/Carbon Ion Therapy System

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  NMPA: Guidelines on Registration of Rare Disease Control Medical Devices

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  Operation Specification for Record Filing of Medical Device Master Files

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  Order No. 15 of the State Food and Drug Administration: Classification Rules for Medical Devices

  $200.00 Add to cart
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  Record Filing Requirement of Medical Device Master Files

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