CFDA

January 17, 2019

CFDA Monthly Roundup (December)

Monthly CFDA News Roundup covers government announcement, policies, standards, guidelines, QA/recall/AE, and new approvals in medical device and IVD in China. It is edited by ChinaMed Device, LLC (www.ChinaMedDevice.com), a […]
January 11, 2019

CFDA Must Read: Acceptance of Overseas Clinical Data

NMPA (CFDA) issued Guideline for Acceptance of Overseas Clinical Trial Data of Medical Devices on January 11th, 2018. A year later, we revisit this important guideline to remind foreign medical […]
December 21, 2018

ChinaMed Device, with Goldman Sachs and Other Industry Leaders, Interviewed by Bloomberg on European Effects of U.S-China Trade War

On Dec 18, ChinaMed Device, LLC is interviewed by Bloomberg on European effects of U.S-China Trade War. Other interviewees include Goldman Sachs, BS Global Wealth Management, and European Union Chamber […]
December 18, 2018

What are the CFDA interpretation of the combination products attributes?

In order to guide the applicant to make proper application, NMPA(CFDA) has published the summary of the attribute definition results of drug-device combination products starting from 2009 to the present. […]
December 14, 2018

NMPA (CFDA): Be Prepared to Have Company Name in Chinese on Your Device Label and IFU

From January 1st, 2019, China requires foreign company names to be provided in Chinese. The Chinese company name must meet following requirements: Use simplified Chinese. Chinese company name should be […]