Class III IVD Product Registration
- Time of issue:2021-06-09 15:42:58
Class III IVDs have higher risks and need special measures to strictly control and manage to ensure their safety and effectiveness. Both domestic and overseas IVD manufacturers need to register with the NMPA.
➣ Required Documents：
2.List of basic requirements for the safety and effectiveness of the product
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
Medical device registration fee standard
Initial Registration Fee
Registration Changing Fee
Registration Renewal Fee (once per 5 years)
1.Medical device 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 medical devices are the same with the registration fees for imported medical devices.
3.Fees for medical device expedited registration shall be formulated separately.
➣ Estimated Timeline:
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 III medical devices without doing clinical trials, the estimated time cost is around 16 to 24 months.
ii.For the new registration of imported Class III medical devices with clinical trials, the estimated time cost is around 36 months (including carrying out clinical trial for at least 12 months).
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