Common FAQ

The applicant may refer to the EO residual limit index for a single piece / set of devices in relevant standards. If reference is made to the allowable limit in GB / T 16886.7-2015, the applicant shall consider the combined use of multiple devices during the actual use of the product, and formulate the ethylene oxide residue limit for a single product / set in combination with the actual control level of EO residue of the product, and provide relevant basis.

If you are using for own device as equivalent device, you definitely have the access to the clinical report. If you use competitor’s device, you will need to find their publicly available resources. In the new technical guidance, the requirement of comparing manufacturing processes is gone and this is good news for us.

For the overseas clinical data, let us say, if you have done a pivotal study in the US or in other markets, you wanted to use the collected data to seek NMPA approval, you definitely can use these data. However, always keep in mind, one of the key requirements to make this strategy successful to write a report proving that your data collected from overseas can be extrapolated to Chinese patients. This is the key to submit the overseas clinical data.

 I would say this is one section required to be included in the CER; you don’t need to create a stand-alone report. You still need the state of the art.

This refers to the advantage of your product. This should be based on existing evidence. Basically, you claim that your device is better than the competitors’ devices or alternative treatment modalities in some ways.

Yes.

They belong to the same category. The benefit of your device generally refers to the effectiveness data or clinical performance data. And on the other hand, the risk of your device generally is related to the safety side.

 I would encourage you to use the decision-making process flowchart, then you will be super clear where you are. You can make your own decision.

They are different from EU CEP. CEP (clinical evaluation plan) is just a planning document which contains the scoping and methodology of clinical evaluation. However, during the design development phase, you have to do the actual clinical evaluation. This is the process you use to determine whether you have sufficient amount of clinical evidence. How should it be documented? This should be documented internally. I don’t think you need to submit this document to the agency.

Please refer to the clinical evaluation exemption catalog. From the excel table, you can find the class II or III devices exempted from clinical evaluation.

This question is not very clear. As we mentioned in the presentation, the clinical data can be generated from subject device, equivalent device or comparable device. If you want to use a comparable device as well, you must summarize the clinical data for all devices to compose your CER.