Blogs

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 […]