March 24, 2017

Clinical Evaluation Reports or Clinical Trials?

China’s new requirements for CERs (Clinical Evaluation Reports) and CTs (Clinical Trials) have now been in place for more than two years.  Understanding the difference and their appropriate use can […]
March 16, 2017

14th Annual Medical Device Quality Congress

March 28-30, 2017 • Bethesda North Marriott • North Bethesda, MD The Annual Medical Device Quality Congress is going strong on their 14thyear. The conference will be located at the […]
March 6, 2017

CFDA Updates 2017.02.10-2017.02.16

China is back from its >10 days national new year celebration.  CFDA is busy releasing more guidelines now.  Since February 10th, 2017, six have been released. Even though they are […]
February 20, 2017

China Targets Sterile Devices, Implants, and IVDs for Inspection

In the previous column, we discussed China’s fast track approval process for innovative medical devices and how products can qualify under a new guideline issued in December 2016. Here we […]
February 8, 2017

China’s Fast Track for Innovative Medical Device Approvals

CFDA issued a new guideline for document preparation of innovative medical device special approval process on Dec. 15, 2016. The initial general decree that governs the general requirements of innovation […]
January 24, 2017

Register for the Webinar! China Medical Device Regulatory Changes

With international trade and trade relations becoming a hot topic in the news as a new president takes his seat in the White House, those manufacturers who currently do business […]
November 10, 2016

Life Sustaining Ventilators Clinical Evaluation Guidelines for Feedback Draft

If you need to provide feedback to CFDA, please let us know and we will consolidate and send it for you.  Please email to . If you want to email […]
October 3, 2016

CFDA QMS Draft Guideline for Feedback: Incoming inspection, manufacturing process and finished goods

I am sharing a response I posted to a question by a manufacturer RA. The Guideline was issued on Sept 21 for further feedback and asked all feedback be emailed […]
September 29, 2016

Reflections on China National Day Gold Week Holiday Oct 1 to 7, 2016

Next week is a long national holiday in China, celebrating the founding of People’s Republic of China in 1949. My inbox will slow down but I know a lot of […]
September 23, 2016

What does the sweeping changes of CFDA regulations mean to your medical devices in China?

Since 2015, more than 100 regulations and laws have passed from the central government mandates to CFDA requirements biggest shakeup since 2000. The changes impact not only premarket submission but […]
July 27, 2016

Companies in non-healthcare industry in China are eager to get into healthcare sector

Companies in non-healthcare industry in China are eager to get into healthcare sector from both supply and demand side. Pharmaceutical companies in China are eager to diversity and transform its […]
July 26, 2016

U.S. Medtech Market Down, China Up

The Investment Trends Report of The 17 Segment Diseases In Recent 20 Years USAThe slowdown in 20 years of US medtech investment in 17 diseases has become the windfall to […]