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Category: NMPA (CFDA) Regulations

2021 China NMPA (CFDA) Bluebook

February 25, 2021

Current China NMPA Clinical Pathways for Medical Device Registration

November 18, 2020

Overview of ART Products in China

September 21, 2020

Drug-Medical Device Combination Products in China

September 21, 2020

NMPA Medical Device Registration & Clinical Trial Process

July 8, 2020

Guideline on AI-Aided Software

July 3, 2019

Operation Specification for Record Filing of Medical Device Master Files

January 3, 2019

Record Filing Requirement of Medical Device Master Files

January 3, 2019

Guideline for Record Filing of Medical Device Master Files (Draft)

January 3, 2019

Announcement on Record Filling of Medical Device Master Files

January 3, 2019

Regulations for Overseas Inspection of Pharmaceutical & Medical Devices

December 26, 2018

Regulations for the Administration of Overseas Inspection of Pharmaceutical & Medical Devices

Tech Guide for Comparing the Same Variety of IVD Exempted from Trials (Draft)

November 22, 2018

Technical Guideline for Comparing the Same Variety of In-vitro Diagnostic Reagents Exempted from Clinical Trials (Draft)

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