CFDA Updates

February 23, 2018

CFDA Quality Notice: 5 Foreign and 52 Domestic are impacted

CFDA issued a Quality Notice and identified 8 types of medical devices with quality issues: RF ablation system, X-ray imaging system, oxygen concentrator, biomedical freezer, surgical blade, etc. 5 foreign […]
February 21, 2018

Shanghai CFDA: 17 Foreign Devices Recalled

Shanghai CFDA office announced Medical Device Recall Notices to 17 foreign device manufacturers from Feb 11th to Feb 17th: •          Konica Minolta: diagnostic ultrasound system •          Edwards Lifesciences: disposable blood […]
February 20, 2018

Weekly CFDA News Roundup (Feb 11 to Feb 17)

CFDA is celebrating Chinese New Year, the year of the dog. There were limited updates for last week. Weekly CFDA News Roundup covers policies, regulations, QA/recall/AE, and new approvals in […]
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 […]