Snapshot

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

This pathway can be used where The filing application is required for class I IVDs, whereas the registration application is required for class II and class III IVD. For imported IVDs, the registration or filing application shall be submitted to the national NMPA. For domestic IVDs, the filing application for class Is shall be submitted to the city-level MPA; the registration application for class IIs shall be submitted to the province-level MPA; and the registration application for class IIIs shall be submitted to the national NMPA. The filing application for class I IVDs shall be done in the following steps without technical review: Prepare technical files; Filing application to the NMPA; Receive notification letter of filing number. The registration processes for class II and Class III IVDs are: Prepare technical requirement and risk analysis report; Perform product testing (could be self-testing report, or third-party accredited testing lab); Clinical trial or clinical evaluation if not exempt from clinical evaluation; Submission for first technical review; QMS audit by the NMPA for domestic manufacturers. Rarely overseas audit for imported manufacturers; Reply to the deficiency letter; Submission for the second technical review; Receive certificate. The following must be registered: Product name, model, specifications; Manufacturer name and address; Manufacturing address; China agent name and address for imported IVDs; Intended use (including sample type, and qualitative or quantitative). .

This pathway facilitates activities during development.

It is an abridged review (a reliance pathway).

Target time assessment is The various classes have different review and approval timelines for IVD's marketing authorization: Class I: when sponsor files with the NMPA (for imported products) or prefecture affiliate of NMPA (for domestic products), as long as the dossier meet requirements, NMPA or its provincial affiliate should issue the filing number immediately. Class II: 60 working days for scientific review, 20 working days for administrative check and 10 working days to issue the certificate, these processes are sequential. Timeline is for both imported and domestic products. Class III: 90 working days for scientific review, 20 working days for administrative check and 10 working days to issue the certificate, these processes are sequential. Timeline is for both imported and domestic products. The above timelines do not include the extra time if supplemental information is requested by NMPA (If supplemental information is requested, it should be provided within one year)..