CFDA has issued 2 new guidelines from June 17rd to June 20th. Even though they are called guidelines, once they are released, you are expected to comply with them whether your products are in the review or new submission phase. Find out how these guidelines impact your devices in China, please contact us atinfo@ChinaMedDevice.com.
1. On June 20th, CFDA issued a technical review guideline on Disposable Infusion Pump (Non-electric Driven) for comments.
It is class III with class code 6866.
The Disposable Infusion Pump (Non-electric Driven) is a medical device used in medical institutions. It injects drugs or biologics into the human body in a controlled pumping mechanism
This guideline does not apply to electric powered or electric-controlled infusion pumps, implanted drug infusion device, enteral nutrition infusion pump, percutaneous infusion devices. The guideline applies to the infusion devices that are controlled and powered by patients direct intervention instead of the devices that are powered and controlled by themselves.
The registration application dossier including:
A. Summary Materials: 1) summary; 2) product description; 3) model specification; 4) packaging; 5) clinical indication and contraindications; 6) comparison with similar or predicate devices.
B. Research Materials: 1) product mechanism; 2) raw-materials control; 3) product performance indicators; 4) biocompatibility evaluation studies; 5) product sterilization; 6) product packaging; 7) product shelf validity period; 8) drug compatibility test
C. Manufacturing information: 1) production process and control; 2) production site
D. Clinical Evaluation Materials: 1) research design and research assumptions; 2) comparison type; 3) clinical indication choice; 4) evaluation criteria; 5) sample size basis; 6) test sample information; 7) quality control of clinical trials; 8) statistical analysis method; 9) patients’ follow-up
E. Product risk analysis materials. 1) list of issues that may affect product safety; 2) list things to identify product hazards.
F. Product technical requirements.
G. Product registration testing
H. Product instruction for use and label
2. On June 20nd, CFDA issued a technical review guideline on Blood and Blood Ingredients Storage Bag for comments.
It is class III with class code 6866.
The blood bag consists of a disposable sterile bag container and its accessories for collecting, storing, processing, transferring, separating and infusing the blood and blood components of the human body. Most of these products have following materials: medical PVC, DEHP, BTHC, and medical polyethylene, etc.
The registration application dossier should include the following parts:
A. Summary Materials: 1) summary; 2) product description; 3) model specification; 4) packaging explanation; 5) clinical indications and contraindications; 6) comparison with similar or predicate devices.
B. Research Materials: 1) the principle of blood ingredients storage; 2) the method, conditions and time of blood components storage; 3) raw-materials control; 4) product performance specification; 5) quality evaluation of stored blood or blood ingredients; 6) the compatibility of blood bags with stored blood ingredients; 7) biocompatibility Evaluation studies; 8) product sterilization; 9) product packaging; 10) product shelf validity period.
C. Manufacturing information: 1) production process and control; 2) production site
D. Product risk analysis materials: 1) list of issues that may affect product safety; 2) list of things to identify hazards
E. Product technical requirements.
F. Product registration testing
G. Product instruction for use and label
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