NMPA Released Six Guidelines for Medical Devices

On September 26, 2020, NMPA released six guidelines for medical devices to strengthen the surveillance and guidance of the registration of medical device products and further improve the quality of registration review. All the new guidelines are:

• Technical Review Guidelines for Balloon Dilatation Catheter Registration
• Technical Review Guidelines for Needle-stick Injury Protective Devices for Infusion Products
• Guidelines on the Evaluation of Biotype Femoral Stem Fatigue Performance
• Guidelines on Virus Inactivation Process Verification for Allogeneic Implanted Medical Devices (Revised 2020)
• Registration Review Guidelines on 3D Printed Patient Matching Mandibular Prosthesis
• Guidelines for Medical Interactive Quality Control and Review of Personalized Matched Bone Implants and Tools

Bradynuoen suggest manufactures to follow the new requirements to do relevant registration.

Link:

http://www.cdr-adr.org.cn/ylqx_1/Medical_zcfg/zcfg_zdyz_m/202009/t20200926_47835.html