Category: NMPA (CFDA) Updates

After a major overhaul in 2014, the CFDA “Regulations on the Supervision and Administration of Medical Devices” have been focusing on registration quality management system

China Med Device publishes weekly CFDA updates covering medical device regulation, guideline, standard, recall, adverse event alert, recall, registration approval. Below are the CFDA updates

On January 5th, 2018, CFDA released a “Medical Device Clinical Trial Design Guidelines.” Here is a summary of the scope, purpose and coverage of this

As part of an effort to standardize the overseas inspection of drug and medical device manufacturing and ensure the quality of imported products, the CFDA just

Recently, in order to speed up the development of advanced manufacturing industries, promote the deep integration of the Internet, big data, artificial intelligence and real

As planned, CFDA is to enforce its “Medical Devices Online Sales Supervision and Management Measures” on March 1st, 2018 that governs online sales of all

1. Scope This guideline applies to the application registration of class II and III mobile medical devices. 2. Mobile Medical Device (1) Definition of Mobile

As part of CFDA’s implementation of reforms to its approval systems for drugs and devices and to meet the clinical demands of medical devices, CFDA

The CFDA issued 12 new guidelines on December 22nd, 2017. While they are titled guidelines, once they are officially released, you are expected to comply with

CFDA has just approved a prothrombin (DCP, PIVKA-II) and alpha-fetoprotein heterogeneity (AFP-L3) ratio of automatic chemiluminescence detection reagents, with China’s first fully independent owned intellectual