FAQ

The analytical performance of in vitro diagnostic reagents includes multiple contents such as accuracy, precision, limit of detection and specificity. It is necessary to include the samples from different sources, types, concentrations and other characteristics according to the specific requirements for various performances, so as to fully evaluate various performances of product. Therefore, the re-use of samples shall be avoided as far as possible in the evaluation process of analytical performances.

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In clinical trials, when clinical samples of the type specified in the instructions for use (IFU) are tested, attention shall be paid to the conformity of technical contents such as sample collection, sample storage conditions, sample storage time, sample processing methods, etc. The claims in the test reagent IFU shall be supported by preclinical studies, and attention shall be paid to the requirements in the IFU of test reagent, reference reagent and recheck reagent.

For example, clinical trials of nucleic acid detection reagents should note that:

• Sample collection methods shall meet the requirements in the IFU;
• Sample storage time shall be within the claimed shelf life of samples;
• Clinical trials shall be performed using original samples, and extracted DNA or RNA nucleic acid shall not be regarded as original samples;
• The supporting nucleic acid extraction/purification reagent and sample storage solution (if applicable) shall be claimed in the IFU of the test reagent and reference reagent respectively;
• If the IFU of the product has requirements for the purity and concentration of extracted nucleic acid, they should meet the relevant requirements in the IFU of the product.

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Definitely not. Changes in clinical functions shall be major updates of software. If the naming rules for software version number specified by the manufacturer cannot clearly distinguish major and minor software updates, software release version number shall follow its higher risk. The software release version in China shall reflect such changes.

For example, the naming rule of software version number developed by the manufacturer is X.Y.Z, of which X represents major update, Y represents minor update and Z represents correction. If the change of clinical function is reflected in the Y field, the software release version number shall be determined as X.Y.

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Detection limit (LOD) is an important performance index of in vitro diagnostic reagents. Generally, three batches of reagents are used for LOD research. If the LOD results differ from batch to batch (generally there should be no significant difference), the maximum value or higher value shall be taken as the claimed LOD of the reagent to ensure that all batches of reagents meet the claim.

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The technical review of clinical evaluation of medical devices is carried out based on the clinical evaluation dossiers submitted by the manufacturer. If CER or clinical trial pathway is adopted for the clinical evaluation of the medical devices under review, for example, after the applicant submits the registration application dossiers, the declared products are listed in the officially released catalogue of medical devices exempted from clinical trials, and the applicant can complete the clinical evaluation through the catalogue of medical devices exempted from clinical trials according to its needs when supplementing the dossiers. In this case, considering the significant changes in the clinical evaluation dossiers in the supplementary dossiers compared to the initial submission, the applicant can communicate with the reviewers through communication channels including post supplementary consultation and preliminary review.

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Some liquid products for in vitro assisted reproduction have entered the Catalogue of Medical Devices Exempted from Clinical Trials. For the products that are not in the catalogue, it is recommended to select appropriate clinical evaluation paths, including clinical trials and CER pathway, based on the actual characteristics of the declared products and the available supporting dossiers.

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If the packaging specification of in vitro diagnostic reagent changes, the difference of packaging specification before and after the change shall be described in detail. All relevant potential risks shall be identified according to the specific differences, and these risk factors shall be analyzed and verified. Some examples are as below:

if there are differences in the reaction form (such as poison detection products) and reaction film size (such as PCR amplification and hybridization products) of the packaging specification before and after the change, the analysis performance evaluation dossiers of the changed packaging specification shall be submitted.Before and after the change, the amount of packaging specifications and containers will change significantly, which will lead to the increase of evaporation loss and other risks. Therefore, it is necessary to consider whether the shelf life, stability and calibration frequency of the product will change.

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Accessories for radiation protection, such as radiation protection clothing, radiation protection cap, radiation protection skirt, radiation protection collar, medical radiation protection glasses, etc., are used for the protection of human body during radiation diagnosis. Such protective accessories usually are connected with active equipment by no power connection or other physical connection. They are managed separately as medical devices in the classification catalogue and are recommended to be declared separately. Except for non-removable accessories.

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In the clinical trial dossiers of in vitro diagnostic reagents, the implementation plan of the clinical trial and the corresponding written comments of the ethics committee agreeing to carry out the clinical trial shall be submitted. Due to the change of clinical trial protocol, there may be multiple versions. The following principles should be noted when submitting application dossiers:

If the the clinical trial protocol changes before the formal implementation of the clinical trial, the clinical trial protocol of the final version shall be submitted, together with the written comments of the ethics committee corresponding to the version.If the clinical trial has started and the protocol is changed in the process, the clinical protocol before and after the change and its ethics documents shall be submitted together, and the reasons for the protocol change and its impact on the conducted clinical trial shall be clearly explained.It should be noted that before the clinical trial, the scientificity, rationality, feasibility and compliance of the protocol should be fully studied, the protocol should be formulated and strictly implemented. During the clinical trial, the protocol shall not be changed at will for unnecessary reasons.

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The endoscopes mentioned in the clinical trial exemption list are limited to conventional-designed products. Endoscopes like disposable electronic endoscopes (including combined endoscopes that are disposable as a whole and only the insertion part is disposable), three-dimensional endoscopes and capsule endoscopes are not included in the clinical trial exemption list.

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Risks vary in different animal sources, production processes and applicable products. For some common virus inactivation processes, such as organic matter, radiation, strong acid, etc., the processes and methods are relatively mature which have many references. Therefore, it is not necessary to carry out laboratory verification one by one. Instead, it can be considered to refer to biological evaluation, immune prototype evaluation, clinical evaluation and other methods, and replace them with literature and historical data. Regarding qualification, there are no relevant provisions in the current medical device regulations.

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