“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 III||CNY 308,800.00|
Budget, contract, cooling-off period (1 month)
Preparation of Application Dossiers before NMPA Acceptance
Preparation, translation and notarization of application dossiers (2-3 months)
Product test (vary from product to product, 6 months on average)
Clinical trials cannot be carried out in parallel with product tests, and the time needed for clinical trials should be calculated separately. (at least 12 months)
The preparation of registration application dossiers can be carried out in parallel with product tests or clinical trials.
After NMPA Acceptance
The time consumed by NMPA according to law: 10 months (188 working days, 20 working days per month, excluding holidays) (at least 10 months)
Time limit for the preparation of supplementary dossiers: 0~12 months, depending on the completeness of application dossiers submitted. (6 months on average)
Total Time Budget
Initial registration of imported Class III IVD (without clinical trials) (estimated: 26 months on average)
Initial registration of imported Class III IVD (with clinical trials) (estimated: 38 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)