CFDA:Regulation Updates for Blood-Related Medical Device

Weekly CFDA News Roundup (June 3rd to June 10th)
June 13, 2018
Weekly CFDA News Roundup (June 11th to June 18th) 
June 23, 2018

CFDA:Regulation Updates for Blood-Related Medical Device

This year, CFDA has issued 8 technical guidelines, 1 innovation approval and 1 class I recall for blood-related medical devices.

Guideline:

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

 

Innovation Approval:

Approval for Revascularization Device

 

Class I Recall:

Magellan Med: Blood Lead Analyzer (inaccurate testing results)

 

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