Snapshot

The Registration of IVDs - China pathway has been developed by the of China.

This pathway can be used where Regulatory Pathways & Jurisdiction: Class I IVDs require a filing application, whereas Class II and Class III IVDs require a formal registration application. Imported IVDs: All filings and registration applications must be submitted directly to the national NMPA. Domestic IVDs: - Class I: Submitted to the municipal (city-level) MPA. - Class II: Submitted to the provincial-level MPA. - Class III: Submitted to the national NMPA.Process Steps Class I (Filing Pathway — Administrative, No Technical Review): Prepare technical files. Submit the filing application to the appropriate MPA authority.Receive the filing notification letter. Class II & Class III (Registration Pathway):Prepare product technical requirements (PTR) and a risk analysis report. Conduct product testing (via self-testing or an accredited third-party laboratory). Complete clinical trials or clinical evaluations (unless exempt). Submit for initial technical review. Undergo a Quality Management System (QMS) audit by the NMPA (mandatory for domestic manufacturers; conducted on rare occasions for overseas manufacturers). Respond to any deficiency letters.Submit for second technical review.Receive the registration certificate.Mandatory Registration FieldsThe following details must be registered:Product name, model, and specificationsManufacturer name and addressManufacturing site addressChina Legal Agent name and address (for imported IVDs)Intended use (including sample type and whether qualitative or quantitative).

This pathway facilitates activities during development.

It is an abridged review (a reliance pathway).

Target time assessment is NMPA IVD Review and Approval Timelines Class I (Administrative Filing):Timeline: Immediate issuance upon verification of dossier completeness.Jurisdiction: Submitted to the national NMPA for imported products, or to the municipal/prefecture-level MPA for domestic products. Class II (Standard Registration — Total: 90 Sequential Working Days): - Technical Review: 60 working days - Administrative Check: 20 working days - Certificate Issuance: 10 working days(Applies to both domestic and imported Class II IVDs.) Class III (Standard Registration — Total: 120 Sequential Working Days): - Technical Review: 90 working days - Administrative Check: 20 working days - Certificate Issuance: 10 working days(Applies to both domestic and imported Class III IVDs.) Supplementary Information Requests: Statutory timelines pause when the NMPA issues a deficiency letter. The applicant is granted a maximum of 1 year to prepare and submit the requested supplemental data. .