Chinese medical device regulatory affairs, clinical affairs, and medical market research resources

NMPA Regulations

Regulation of Medical Device by State Council

Regulation of Medical Device

Requirement for Registration

Regulation on IFU and Labels

Classification Rules

CFDA Recall Policy

Requirements for IVF Reagent Registration

Regulation for Registration of IVD Reagent

General Materials

NMPA Submission Dossier – Class II & III Imported Products

Guidance on Drafting Product Technical Requirements

Software Description Document

Guidance on Clinical Evaluation

Guidance on Clinical Trial of IVD Reagent

Guidelines for IFU of IVD Reagent