Blogs

February 16, 2018
innovation

Molecular Diagnostics in China: A Growth Industry

Molecular diagnostics plays an important role in Reprogenetics and Oncology, which has attracted more attention from the public than ever before. In China, there are about 16 million new births […]
February 13, 2018

New CFDA Technical Review Guideline for CT

On February 9th, 2018, CFDA issued a new technical review guideline on Computed Tomography X-Ray Systems (CT). CT is categorized as Class III device by CFDA in China. The guideline covers […]
February 8, 2018

CFDA: Be Prepared to Have Company Name in Chinese on Your Device Label

CFDA has a new requirement that foreign applicants, registrants and filers shall use Chinese languages for company name in medical device registration. The Chinese company name should meet the following […]
February 8, 2018

Monthly CFDA News Roundup (January 2018)

Monthly Updates Digest from CFDA edited by China Med Device, LLC, a consulting firm specializing in China CFDA regulatory, CRO and market access services. News coverage area: CFDA policies, regulations, […]
February 8, 2018

6 Foreign Devices Recalled Last Week

CFDA issued medical device recall reports to 16 manufactures from Jan 28th to Feb 3rd. There are six foreign manufacturers on the list:   •             Edwards Lifesciences: venous sheath •             […]