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Category: NMPA (CFDA) Regulations

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

Guideline for Technical Review of Mobile Medical Device Registration

December 29, 2017

Supervision and Administration of Medical Device Production

November 21, 2017

Number 650 Regulations on Supervisory Management of Medical Devices

November 13, 2017

Requirements for Clinical Evaluation of IVD Exempted from Trial (Draft)

November 8, 2017

Basic Requirements for Clinical Evaluation Materials of IVD Exempted from Clinical Trial (Draft)

Using Chinese Name for Registrant or File Submitter of Imported Medical Devices

November 2, 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

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