Medical Devices

Illegal and non-compliant medical device online sales for up to 6 cases were reported in China by the NMPA on June 30, 2023.

A registration review guideline for clinical evaluation of spinal fusion devices issued by the Center for Medical Device Evaluation (CMDE).

20 new industry standards for medical devices have been approved recently by the National Medical Products Administration (NMPA).

Coronavirus product manual changes are required by the NMPA in China. Notice No. 349 (2023) outlines important modifications for Coronavirus nucleic acids, antigens, and antibodies detection reagents.

China medical device standards update plan 2023 has been announced by the National Medical Products Administration (NMPA).

IVD Reagent Registration Change Review Draft Guidelines have been issued by CMDE in draft format for industry comment by June 30, 2023.

China suspends bone graft material from HansBiomedCorp (South Korea) following a remote off-site inspection by the NMPA.

Physicochemical characterization of nanomaterials used in medical devices encompasses the evaluation of various properties

Registration of disposable light-proof infusion sets in China shall refer to the technical review guidelines revised by the CMDE in April 2023

Registration of disposable blood separation devices in China shall refer to the technical review guidelines revised by the CMDE in April 2023.

Registration of disposable infusion devices in China shall refer to the technical review guidelines revised by the CMDE on April 28, 2023.

Registration of blood dialyzers in China shall refer to the technical review guidelines revised by the CMDE on April 28, 2023.