Codex News

The collection of the latest CFDA regulations for medical device in English version is in publishing

Updated: 2016/4/28

The collection of the latest CFDA regulations for medical device in English version, soundly translated and prepared by Codex’s medical device translation team, is now officially published. It contains:

1.   Regulations for the Supervision and Administration of Medical Devices

2.   Measures for Unannounced Inspection of Drugs and Medical Devices

3.   Notice on Release of Charging Standards for Drug and Medical Device Product Registration Fees by CFDA

4.   Notice on Issuing Requirements for Application Dossiers and Approval Document Formats for Medical Device Registration by CFDA

5.   Technical Guideline for Clinical Evaluation of Medical Devices by CFDA

6.   Classification Determination and Operation Guide for Class I Device

7.   Notice on Special Review and Approval Procedure for Innovative Medical Devices (Interim) by China Food and Drug Administration

8.   Catalogue of Class III Medical Device Exempt from Clinical Trail (Second Batch)

The collection of CFDA regulations for medical device in French and German version will be coming soon. Meanwhile the collection of CFDA regulations for drugs is in progress.