“IVD reagent” as mentioned in the Provisions on Registration of IVD Reagents refers to any IVD reagent product that is regulated as a medical device, which is a reagent, kit, calibrator or control material, whether used alone or in combination with an instrument, apparatus, device or system, intended by the manufacturer to be used in vitro for the examination of specimens derived from the human body, for the purpose of providing information in the process of prediction, prevention, diagnosis, treatment monitoring or prognosis observation of a disease, or health status evaluation.
IVD reagents used for blood screening and those labeled with radionuclides that are regulated as drugs do not fall under the Provisions on Registration of IVD Reagents.
IVD reagents are divided into Class I, II and III, taking into account their risk levels, ranging from low to high.
Official Administrative Charges
|Imported Class II||CNY 210,900.00|
Clinical trials cannot be carried out in parallel with product tests, and the time needed for clinical trials should be calculated separately. (at least 9 months)
The time consumed by NMPA according to law: 8 months (158 working days, 20 working days per month, excluding holidays) (at least 8 months)
Total Time Budget
Initial registration of imported Class II IVD (without clinical trials) (estimated: 24 months on average)
Initial registration of imported Class II IVD (with clinical trials) (estimated: 33 months)
Initial Registration of Imported Class III IVD
Registration Renewal of Imported Class III IVD
Initial Registration of Imported Class II IVD
Registration Renewal of Imported Class II IVD
Application for Innovative Medical Device (Imported)