CFDA Updates 2017.02.10-2017.02.16

China Targets Sterile Devices, Implants, and IVDs for Inspection
February 20, 2017
Clinical Evaluation Reports or Clinical Trials?
March 24, 2017

CFDA Updates 2017.02.10-2017.02.16

China is back from its >10 days national new year celebration.  CFDA is busy releasing more guidelines now.  Since February 10th, 2017, six have been released. Even though they are called guidelines, once they are released, you are expected to comply with them whether your products are in the review phase or new submissions. If you need any detailed information regarding these guidelines and how they impact your devices in China, please contact us at .

  1. On February 10, CFDA issued a technical review guideline on Medical Compression Stockings.

It is class II with class code 6824.

Medical compression stockings mainly used for preventing venous thrombosis of lower limbs, or relieving the symptoms of varicose veins of lower limbs. This kind of product has gradient pressure which decline gradually up from ankle. Medical compression stockings give pressure to vessel lumen which help venous blood flow to the heart. This prevent venous congestion, ensure good venous blood circulation and alleviate leg swelling and other symptoms for patients.

  1. On February 10, CFDA issued a technical review guideline on Central Venous Catheter.

It is class III with class code 6877.

Central Venous Catheter is intravascular catheter which used for blood purification, liquid infusion, blood sampling and measurement of central venous pressure. The catheter can be inserted into central venous system via the internal jugular vein, femoral vein or subclavian vein. According to the structure, central venous catheter can be divided into Single lumen catheter double lumen catheter and three lumen catheter. Central Venous Catheter in this guideline do not include PICC and Catheter with Embedded Venous Transfusion Port.

  1. On February 10, CFDA issued a technical review guideline on Bone Filling Material (Calcium phosphorus / silicon).

It is class III with class code 6846.

Bone filling material (Calcium phosphorus / silicon) including synthetic calcium phosphate bioceramics, calcium silicate bioactive glass and calcium phosphate cement. Bone filling material is used for repair bone defects caused by trauma and surgery.

  1. On February 16, CFDA issued a technical review guideline on Artificial Hip Prosthesis.

Artificial Hip Prosthesis is class III with class code 6846.
The product is intended for artificial hip prosthesis replacement, including acetabular components, femoral component, centralizer, Bone cement plug.

  1. On February 16, CFDA issued a technical review guideline on Cervical Disc Prosthesis.

It is class III with class code 6846.

This product is used for cervical disc prosthesis replacement, including the upper end plate, Prosthetic Disc Nucleus and the lower end plate. It is made by metal and its alloy, coating material, ultra-high molecular weight polyethylene or ceramics.

  1. On February 16, CFDA issued a technical review guideline on Drug Resistant Mutant Gene of Mycobacterium Tuberculosis Complex Detection Reagent.

It is class III with class code 6834.

Drug Resistant Mutant Gene of Mycobacterium Tuberculosis Complex Detection Reagent refers to reagents which use molecular biology techniques to detect Mycobacterium Tuberculosis Drug Resistance Mutant Gene in cultivation or clinical samples of TB patients.

 

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