Class II IVD Product Registration

According to the Administrative Measures for the Registration of IVDs, IVD is a product such as reagent, kit, calibrator, and quality control product for in vitro testing of human samples. It can be used alone or in combination with instruments, appliances, equipment or systems.

In accordance with drug management, IVDs used for blood source screening and IVDs labeled with radionuclides do not fall within the management scope of the Administrative Measures for the Registration of IVDs.

➣ Required Documents：

　1.Proof documents

　2.List of basic requirements for the safety and effectiveness of the product

　3.Summary information

　4.Research materials

　5.Manufacturing information

　6.Clinical evaluation data

　7.Product risk analysis data

　8.Product technical requirements

　9.Product registration inspection report

　10.Sample manual and label

　11.Declaration of conformity

➣ NMPA Administrative Fee

Note:

1.IVD product registration fees are calculated and collected in accordance with the Administrative Measures on the Registration of In Vitro Diagnostic Reagents.

2.The registration fees for Hong Kong, Macau, and Taiwan IVDs are the same with the registration fees for imported IVDs.

3.Fees for IVDs expedited registration shall be formulated separately.

➣ Estimated Timeline:

　1)Project Establishment

　　i.Consideration period, budget estimation, proposal and contract setup, about 1 month

　2)Document Preparation before NMPA Acceptance

　　i.Average time cost of product testing: about 6 months.

　　ii.Clinical trials cannot be performed concurrently with product testing. Clinical trial time shall be calculated separately and be expected at least 12 months.

　　iii.For actuarial calculations, please contact us.

　　iv.The preparation of registration application documents can be concurrently prepared with testing or clinical trial.

　3)After NMPA Acceptance

　　i.NMPA reviewing time cost: about 10 months (188 work days, 20 work days per month, excluding holidays)

　　ii.The time limit for document supplement is 0 to 12 months and the average time period is 6 months. It highly depends on the situation of the documents for primary registration application of the product.

　　iii.According to regulations, NMPA going overseas to perform local unannounced inspection is possible.

　4)Total Time Budget

　　i.For the new registration of imported Class II IVDs which do not need to carry out clinical trials, the estimated time cost is around 16 to 24 months.

　　ii.For the new registration of imported Class II IVDs which need to carry out clinical trials, the estimated time cost is around 36 months (including carrying out clinical trial for at least 12 months).