This year, CFDA has issued 8 technical guidelines, 1 innovation approval and 1 class I recall for blood-related medical devices.
Technical Guideline on Continuous Glucose Monitoring Device;
Technical Guideline on Plasma Concentration System;
Technical Guideline on Whole Blood and Storage Bag of Blood Components;
Technical Guideline on Ultrasonic Cutting and Coagulation System;
Technical Guideline on Automatic Hematology Analyzer;
Technical Guideline on Blood Grouping Reagent (ABO and RhD);
Pre-Clinical Guideline on Coronary Drug-Eluting Stent;
Clinical Guideline on Coronary Drug-Eluting Stent
Approval for Revascularization Device
Class I Recall:
Magellan Med: Blood Lead Analyzer (inaccurate testing results)
About China Med Device, LLC
China Med Device, LLC provides turn-key solutions for western medical device/IVD companies to enter China with regulation and commercialization services. Our CFDA regulatory services cover strategy, premarket submission, clinical evaluation, CRO, QA and post market compliance. We are experienced in handling innovation approval and priority review. Our commercial services cover market assessment research, reimbursement, partnership, distribution qualification and management. We have offices in Beijing, Suzhou and Boston. Our management team has 100+ years of combined experience in medical device and IVD and has been involved with 1,000+ CFDA certificates, 200+ companies’ success.