Exhaustive Extractions

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China FDA Launches New Guidelines

Since returning from the country’s New Year Celebration in early February, the China FDA (CFDA) has released a minimum of six new technical review guidelines.  These new guidelines include: 

Device:  Bone Filling Materials

Class III, Release Date:  February 10, 2017

This technical review guideline addresses bone filling materials (i.e. silicone/calcium phosphorous) are utilized to repair bones following surgery or trauma. 


Device:  Central Venous Catheter

Class III, Release Date:  February 10, 2017

This technical review guideline addresses intravenous catheters used for a variety of applications including blood sampling, blood purification, measurement of central venous pressure and liquid infusions.  It does not address catheters with venous transfusion ports, nor does it address Peripherally Inserted Central Catheters (PICC lines).


Device:  Medical Compression Stockings

Class II, Release Date:  February 10, 2017

This technical review guideline addresses medical compression stockings that are utilized to prevent venous congestion of the lower extremities.


Device:  Cervical Disc Prosthesis

Class III, Release Date:  February 16, 2017

This technical review guideline addresses cervical disc prosthesis replacements made from ultra-high molecular weight polyethylene (UHMWPE), metal and metal alloys, ceramics and coating materials used during the manufacturing of these devices.


Device:  Artificial Hip Prosthesis

Class III, Release Date:  February 16, 2017

This technical review guideline includes centralized artificial hip prosthesis, acetabular and femoral components as well as bone cement plugs.


Device:  Drug Resistant Mutant Gene Mycobacterium Tuberculosis Complex Detection Reagent

Class III, Release Date:  February 16, 2017

This technical review guideline addresses the reagents used in the Mycobacterium Tuberculosis Drug Resistance Mutant Gene detection assay.   This review discusses reagents used to test both clinical and cultured tuberculosis samples.


Importantly, compliance with these technical guidelines is now required for both new regulatory submissions to CFDA and submission currently under review by the Agency.

 

 

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Tuesday, 17 September 2019
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