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 a manufacturer intends to add more sterilization methods in a change of permission items, the corresponding sterilization verification data and test the sterility performance should be submitted. Any other performance changes caused by the addition of sterilization methods should be tested. For example, if ethylene oxide sterilization method is newly added, sterility test and ethylene oxide residue test must be added.

In the clinical trials of in vitro diagnostic reagents, all tests shall be completed by the institution undertaking the clinical trials. However, a third-party testing institution may be entrusted if all the following conditions are met:

The reference methods for laboratory testing are adopted for the comparison methods,These methods are not routine clinical testing technologies,Require special equipment, instruments and test conditions, andClinical trial institution do not have relevant testing conditions

The test results of the third party shall be recognized by the clinical trial institution. For example,tests for nucleic acid sequencing and GC-MS / MS test could meet the above conditions. However, if the comparison method is a routine clinical test method, such as general pathogen isolation and culture, micro broth dilution method (for in vitro antibiotic susceptibility test), although the test operation is complex and requires special laboratory conditions and testing technology, the test should still be completed by the clinical institution instead of a third-party laboratory. In order to ensure the quality of clinical trials, clinical institutions capable of undertaking relevant trials should be selected to carry out clinical trials. In the process of clinical trials, relevant trials should be strictly standardized, and the consistency eval

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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.

 if you plan to use your own clinical study data, you do not need to demonstrate equivalency.

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.