NMPA China have published a list of updated Medical Device Standards including some for IVDs including:
15 – 17α-Hydroxyprogesterone Assay Kit (Labelled Immunoassay)
17 – Information provided by the manufacturer of the medical device
18 – Motor Neuron Survival Gene (SMN) Assay Kit
19 – Aldosterone Assay Kit (Chemiluminescence Immunoassay)
20 – Colorectal Cancer-relate d Gene Methylation Detection Kit (Fluorescent PCR Method)
21- Tacrolimus assay kit
24 – Flow cytometer
25 – Preimplantation chromosomal aneuploidy analysis software
26 – Microalbumin Assay Kit (Immunoturbidimetry)
27 – Lipoprotein-associated phospholipase A2 assay kit (chemiluminescent immunoassay)
You can find the full list here.
