July

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 31, 2017

Impact of China’s Cybersecurity Law on Connected Medical Devices

China’s first cybersecurity law came into effect in this year, bringing with it new requirements and protections. The medtech industry should take note of its impact on connected devices. Importance […]
July 29, 2017

Johnson & Johnson Medical Device Division: Materializing China’s Future Prospects and Growth Potential

In the second quarter of 2017, Johnson & Johnson (JNJ)’s US medical device sales grew 6.1%. Although JNJ faces stiff competition in China, its medical device sales in this emergent […]
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 26, 2017

In-Vitro Diagnostics (IVD) Market in China Will Triple In Size Through Next 5 Years

According to recent market study published by Renub Research, China’s In-Vitro Diagnostics (IVD) is likely to grow at a CAGR of 19% and become three times as large by the […]