March 24, 2017
March 24, 2017
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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
March 16, 2017
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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
March 6, 2017
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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
February 20, 2017
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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
February 8, 2017
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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
January 24, 2017
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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
November 10, 2016
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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
October 3, 2016
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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
September 29, 2016
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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
September 23, 2016
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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
July 27, 2016
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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
July 26, 2016
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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 […]