July

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 […]
July 23, 2017

Shanghai-Israel Fund Lead $9M Round In Rapid Medical

Rapid Medical, an Israeli company focused on the development of neurovascular interventional devices, has completed a US$9 million series B financing to advance the commercialization of the company’s minimally invasive […]
July 22, 2017

China Is Competing With US To Lead AI And That Affects The Medical Device Industry

In this year, there are signs that China is the close second to US and is getting head in some of the key AI areas. AI is now widely considered […]
July 20, 2017

China Is Now World’s Second Largest Market for Orthopedic Medical Devices

China has recently surpassed Japan as the second largest market for orthopedic medical devices in the world. With an aging population and improvement in health insurance policies, the demand for […]
July 20, 2017

CFDA Issued new guidelines on HP Antigen/Antibody Testing Regent and 3 More Medical Device/IVD for Comments

CFDA has issued 4 new guidelines from June 29rd to July 4th. Two of them are for IVD registration and the other two is for medical device. Even though they are called guidelines, once they are released, you are expected to comply with them whether your products are in the review or new submission phase. Find out how these guidelines impact your devices in China, please contact us at info@ChinaMedDevice.com.

  1. The registration technical review guideline for Helicobacter Pylori (HP) Antigen / Antibody Testing Reagent for comments.
  2. The technical review guideline on HCV Genotyping Testing Reagent for comments.
  3. The clinical evaluation technical review guideline on Endometrial Removal Equipment for comments.
  4. Clinical evaluation technical review guideline on Proton/carbon Ion Treatment System
July 20, 2017

CFDA Wants to Ensure Quality of Data In Medical Device Registration

As part of its effort to ensure the quality of data in medical device filings, CFDA has published documents to overhaul the regulation of how medical devices are developed and […]
July 18, 2017

China Determined to Become A Leader In Life Science Innovation

A recent article published by Forbes finds that China’s recent life science policy announcements suggest that the best science and strongest most innovative companies – regardless of country of origin […]