Guideline & Standard

Medical Device Cybersecurity Registration Review Guidelines (Revised, 2022)

Guidelines For Technical Review Of Virus Inactivation Process Verification For Allograft Implanted Medical Devices (2011 Revision) (Ineffective)

Guidelines For Technical Review Of Virus Inactivation Process Verification For Allograft Implanted Medical Devices (2019 Draft For Comments)(Final)

Guidelines For Technical Review Of Registration Of Animal-Derived Medical Devices (2017)(Final)

Guidelines For Technical Review Of Registration Of Medical Devices For Human In Vitro Assisted Reproductive Technology(Final)

NMPA Interpretation On Review Guideline Of Animal Studies For Medical Device Registration (Final)

YYT 1535-2017 Medical Devices For Human In Vitro Assisted Reproductive Technology Biological Evaluation—Human Sperm Survival Assay

YYT 1513-2017 Industry Standard On C-reactive Protein Testing Kit

YYT 1434-2016 Medical Devices For Human In Vitro Assisted Reproductive Technology—In Vitro Mouse Embryo Assay

Technical Review Guidelines For Hydrogel Dressing Registration

Technical Review Guideline On Fetal Chromosome Aneuploidy Test Kit (High-throughput Sequencing Method)

Technical Review Guideline Of Pulse Oximeter Registration 2017