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New 3D printed medical device draft guideline will propel China to be the leader in innovation & market acceptance in orthopedic and dental applications. CFDA
Introduction CFDA developed this document to provide guidance to industry and CFDA staff about current technical review for customize-designed additive manufactured (3D-printed) medical device. I.
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
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,
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,
Shanghai CFDA office announced Medical Device Recall Notices to 17 foreign device manufacturers from Feb 11th to Feb 17th: • Konica Minolta: diagnostic ultrasound system
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,
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
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
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
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
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