Class II MD Registration

Class II medical device is with moderate risk and requires strict control and management to ensure its safety and effectiveness. Foreign medical device manufacturers need to entrust a domestic agent to do the registration with NMPA.

➣Required Documents:   

　1.Proof documents

　2.List of basic requirements for the safety and effectiveness of the medical device

　3.Summary information

　4.Research materials

　5.Manufacturing information

　6.Clinical evaluation report

　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.Medical device product registration fees are calculated and collected in accordance with the Administrative Measures on Medical Device Registration.

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:

　1)Project Establishment 

　　i.Period of internal discussion, 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 medical devices 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 medical devices 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).