Blogs

August 10, 2018

Monthly CFDA News Roundup (July)

Monthly CFDA News Roundup covers government reports, policies, standards, guidelines, QA/recall/AE, and new approvals in medical device and IVD in China. It is edited by China Med Device, LLC (www.ChinaMedDevice.com), […]
August 7, 2018

China Counters U.S. Tariff – Time for More Manufacturing Setup in China

The China State Council issued tariff plan worth $60 billion on the 2nd batch of goods imported from U.S. on August 3. It will impose duties of 25%, 20%, 10% […]
August 1, 2018

CFDA New Medical Device Classification Catalogue Effective August 1st, 2018

CFDA Medical Device Classification Catalog draft was published August 31, 2017.  A year later, it became effective on August 1, 2018. New registration application after August 1, should follow the […]
July 31, 2018

Overseas Inspection: There are Defects CFDA Chasing

Following the 13th Five Year Plan (2016-2020), CFDA has conducted overseas inspection covering all imported high-risk medical devices. Since November 2017 when CFDA began to publish overseas inspection results, 24 […]
July 25, 2018

Weekly CFDA News Roundup (July 16th to July 22nd)

Weekly CFDA News Roundup covers government reports, policies, standards, guidelines, QA/recall/AE, and new approvals in medical device and IVD in China. It is edited by China Med Device, LLC (www.ChinaMedDevice.com) […]