February

February 28, 2018

CFDA Overseas Inspection: 37 Violations from 8 Foreign Device Manufacturers

CFDA overseas inspection has intensified. On Feb 27, 2018, CFDA announced overseas inspection results from 8 foreign medical device manufacturers with 37 observations. If you need details of these observations, […]
February 27, 2018

Weekly CFDA News Roundup (Feb 18th to Feb 24th)

Weekly CFDA News Roundup covers policies, regulations, QA/recall/AE, and new approvals in medical device and IVD in China.  It is edited by China Med Device, LLC, a consulting firm specializing […]
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 16, 2018

Reimbursement Change Calls for Quality IVD

To control the rising healthcare cost, China has established a prospective payment system (PPS) to reimburse hospitals for the treatment of patients; from diagnosis to full recovery. The PPS is […]
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 •             […]
February 8, 2018

Edwards Lifesciences got innovation approval from China CFDA

China accelerates medical device innovation. In January 2018, four products got approved through fast track pathway in January. United Imaging: medical linear accelerator system Edwards Lifesciences: transcatheter heart valve and […]