CFDA Updates

January 26, 2018

Weekly CFDA Updates (Jan 14-20)

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 from January 14 to January […]
January 24, 2018

CDFA Released Technical Guidelines for The Registration of Animal-Derived Medical Devices

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 document.   This guideline is […]
January 22, 2018

New Landscape of Medical Device Clinical Trial— CFDA’s Requirements for Accepting International Clinical Data

On January 11, 2017, the CFDA issued a guideline for accepting medical device international clinical trial data. This new guideline could benefit foreign medical device manufacturers by facilitating their clinical […]
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 […]