Blog

August 14, 2017

Review of the Rapid Growing China’s Cardiovascular Device Market

China med Device, LLC provides market access research for Western medical device companies.  Recently MinSheng Pharma published an in-depth analysis on China CVD market. CVD is not only the top […]
August 11, 2017
innovation

Interpretation to the Relevant Issues about the Fast Approval Track for Innovative Medical Devices

China Food and Drug Administration (CFDA) pays high attention to the innovation and development of medical device industry. In order to better implement the “Fast Review and Approval Track for the […]
August 10, 2017

June 2017 CFDA Medical Device Registration and Review Report

CFDA Application Acceptance According to Insight-China Pharma Data, a total of 304 medical devices registration were accepted in June 2017 (counted by numbers of acceptance), which stayed at the lowest […]
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 […]
August 2, 2017

Market Snapshot: C-Bridge Raises $400 Million For Second China Healthcare Fund

C-Bridge Capital, a China private equity firm with a life science focus, closed its second fund, C-Bridge Healthcare Fund II, at its $400 million cap. C-Bridge plans to invest in […]
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 […]
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 of medical […]
July 24, 2017

Trend in 2017: Impact of China’s Two-Invoices Policy on Medical Device Industry

In 2017 the Two-Invoice System policy will evolve from last year’s pilot to full implementation, large enterprises will descend the channel while small and medium-sized agents will be eliminated, some […]