Blogs

August 12, 2018

Introduction of CFDA Approved Combination Products

In 2017, CFDA announced the first batch of approved combination products in China In 2017, CFDA announced the first batch of approved combination products since the release of the combination […]
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 […]