CFDA Updates

January 17, 2018

CFDA Issued Guideline for Clinical Evaluation of Proton/Carbon Ion Therapy System

This guideline is to inform the applicants on the Clinical Evaluation of Proton and Carbon Ion Therapy System. This document does not fully cover the clinical evaluation data that may […]
January 15, 2018

CFDA Published Drug And Medical Device Overseas Inspection Regulations

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 published the Draft for Comments […]
January 11, 2018

China’s “Three-Year Action Plan for Enhancing the Core Competence of Medical Device Manufacturing Industry (2018 – 2020)”

  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 economy, and break through […]
January 11, 2018

Key Takeaways from CFDA’s “Medical Devices Online Sales Supervision and Management Measures”

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 medical devices in China.   […]
January 10, 2018

CFDA Issued Registration Technical Review Guidelines for Mobile Medical Devices

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 Medical Device A “mobile medical […]