China IVD Registration Watch: May 2025

For IVD products entering China, the registration pathway depends on accurate classification, product-specific technical requirements, and a defensible clinical evaluation strategy. This news brief highlights the files that should be kept aligned before submission.

Documentation priorities

• Confirm product classification and intended use before finalising the registration strategy.
• Align analytical performance, clinical performance, reference intervals, and risk controls with the claimed use.
• Keep product technical requirements, test reports, labels, instructions for use, and quality documentation under controlled revision.

Practical impact

Late changes to intended use, specimen type, software, or performance claims can affect the evidence package. A gap review before testing and dossier compilation helps avoid rework during technical review.

Source to monitor

Monitor NMPA announcements and the relevant medical device technical review guidance for the latest China requirements.