“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 40,800.00|
Preparation of Application Dossiers before NMPA Acceptance
Translation and notarization of application dossiers (1-2 months)
Information collection (the customer providing relevant information; searching for new standards, guidance documents and literatures; judgment of changes) (1-2 months)
Revision of Product Technical Requirements (PTR): It is estimated that the preparation of PTR will take at least 20 working days, and the first draft must be translated and confirmed with the overseas applicant. (2 months)
* Product test (if needed) (* about 6 months)
After NMPA Acceptance
Preparation of application dossiers for registration renewal (2-3 months)
The time consumed by NMPA according to law: 5 months (98 working days, 20 working days per month, excluding holidays) (at least 5 months)
* Supplementation and correction (if applicable): 1. Time limit for the preparation of supplementary dossiers: 0~12 months, depending on the completeness of application dossiers submitted. * 6 months on average
* Supplementation and correction (if applicable): 2. It is estimated that the technical review of supplementary dossiers will take 3 months (60 working days) (* 3 months)
Total Time Budget
Supplementation and correction is not required (estimated: 14 months on average)
Supplementation and correction is required (estimated: 23 months on average)
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)