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Category: Resources

Reporting Individual Cases of Medical Device Adverse Event

September 20, 2018

Guide for License Holder on Collecting and Reporting Individual Cases of Medical Device Adverse Event

Guidance on Medical Device Adverse Event Monitoring Scope

September 20, 2018

Guidance on Medical Device Adverse Event Monitoring

September 20, 2018

Medical Device Adverse Event Monitoring and Re-evaluation

August 31, 2018

Measures for the Administration of Medical Device Adverse Event Monitoring and Re-evaluation

Unique Device Identification (UDI) Implementation Plan (Draft)

August 22, 2018

Guideline on High-throughput Sequencing Method Performance Evaluation

August 14, 2018

Guideline for Clinical Trial of Soft Contact Lenses

July 5, 2018

Guideline for Orthokeratology Rigid Gas Permeable (RGP) Contact Lenses

July 5, 2018

Guideline for Clinical Trial of Orthokeratology Rigid Gas Permeable (RGP) Contact Lenses

Amended Regulation on Supervision and Management of Medical Devices (Draft)

June 25, 2018

Tech Guide on Customized Additive Manufactured (3D Printing) Medical Device (Draft)

February 26, 2018

Technical Review Guideline on Customized Additive Manufactured (3D Printing) Medical Device (Draft)

Guidance for Clinical Evaluation of Proton/Carbon Ion Therapy System

January 8, 2018

Medical Device Clinical Trial Design Guideline

January 8, 2018

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