Register for Upcoming Webinar on DEC. 8 @ 11AM

China Green Pathways: Expedite your Market Entry in China

2024 China NMPA Bluebook is here:

Download Your Copy Today

Category: Guideline & Standard

Current China NMPA Clinical Pathways for Medical Device Registration

November 18, 2020

Drug-Medical Device Combination Products in China

September 21, 2020

Guideline on AI-Aided Software

July 3, 2019

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

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

Guideline for Technical Review of Mobile Medical Device Registration

December 29, 2017

Guide to Passive Implantable Medical Device Shelf Life Registration

May 26, 2017

Guideline of Passive Implantable Medical Device Shelf Life Registration Submitted Documents

Technical Review Guideline on Fetal Chromosome Aneuploidy Test Kit

April 1, 2017

Technical Review Guideline on Fetal Chromosome Aneuploidy (T21, T18, T13) Test Kit (High-throughput Sequencing Method)

Industry Standard on C-reactive Protein Testing Kit

March 28, 2017

Search

Get Updated

Receive Updates in Your Inbox

Categories

Archives