CFDA Updates

August 8, 2017

A China-US Joint Meeting Held For Medical Device Clinical Trial Supervision and Exchange

In this month, a Sino-US medical device clinical trial supervision exchange meeting was jointly held by the CFDA’s department of international cooperation, medical devices management department and the U.S. Food […]
August 7, 2017

China Deepening Its Medical Device Registration and Regulation Reform

On July 19, the 37th Meeting of Comprehensively Deepening Reform Leading Group of the Central Committee of the Communist Party of China was held, which deliberated and approved“The Opinions about […]
July 31, 2017

CFDA’s Approval Of Gilupi’s CellCollector for In-Vivo CTC Isolation Signifies The Importance of Partnership Between International Medical Device Manufacturers and Chinese Local Firms

To enter the Chinese market, partnership forged between international medical device manufacturers and local Chinese firms is on the rise. In such partnership, the medical device companies are working with […]
July 27, 2017

CFDA Updates:CFDA Has Issued 2 Notice on On-site Consultation

CFDA has restricted industry from dropping in or visiting its premarket submission review staff in the 6 departments (medical devices and IVDs) prior to registration or submission of the dossier.  Industry can certainly understand the limited resources that CFDA has.  FDA has the equivalent of 700 staff with a fewer submissions.  CFDA has about 100 staff with more submissions. With so many changes in its updates and regulations, industry certainly needs clarity and onsite consultation prior to registration or submission. The current scheduled onsite consultation by each of the 6 departments certainly is a good step forward to address medtech industry's challenges. Medtech industry in China certainly hopes to see the day when companies can interact with CFDA review staff more openly and freely. 

In addition to the onsite visit, CFDA also released online reservation system for companies to make appointments with the reviewers.

  1. Notice on "On-site Consultation on technical issues before medical devices registration"

  2. Notice on "Enabled CFDA Administration Acceptance Service Hall Online Reservation System

July 25, 2017

Highlights 2017 CFDA Medical Device Registration and Regulation Reform – Illustrated

  CFDA just published a visual illustration of its current reform in medical device registration and regulation.   As highlighted, CFDA are focusing in these FOUR AREAS from this round […]