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Common FAQ

After The ERPS System Is Launched, How Can I Submit Supplementary Materials For Registration And Declaration Through Online Channels?
The registration application submitted through the online channel still needs to be supplemented by the administrative counterpart through the online route. After viewing the electronic documents online, it can be added on the system webpage or client after the previous declaration. However, an item for a data verification code can only be submitted once for acceptance and has a new data verification code. The operation of linking the previous declaration on the system webpage is to click “Regenerate” under the original project. The new project containing the previous declaration information can be automatically generated on the top. The administrative counterpart can modify the application form, upload the application form attachment, delete the declaration information or add additional supplementary information. The operation of the system client to associate the previous declaration is to click “copy” on the client interface, enter the verification code for the previous declaration and click "query", and a new item containing the information of the previous declaration can be automatically generated. The administrative counterpart can modify the application form, upload the application form attachment, delete the declaration information or add additional supplementary information. For specific operation procedures and screenshots, please log in to the applicant's window and download the “Corporate Electronic Application Acceptance Correction Operation Guide” for operation.
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After The ERPS System Is Launched, How Can I Submit Supplementary Materials For Review And Registration Through Online Channels?
The registration application submitted through the online channels requires the administrative counterpart to supplement the review stage online. After reviewing the correction information online, the supplementary information can be provided through the system webpage or the client within the time required by regulations. The operation of submitting supplementary information on the system webpage is to click "review and make corrections” under the original project, and upload the supplementary information description, the word file submitted synchronously, and the supplementary information corresponding to each supplementary opinion in the corresponding positions. The operation of the system client to submit supplementary information is to click “Get Data” in the client interface, enter the project acceptance number, and click “Query”. The system can automatically generate the synchronization information of the supplementary project. After confirming, click “Synchronize” and click explanation of supplementary materials, word documents submitted concurrently, and supplementary materials corresponding to supplementary opinions one by one. For specific operating procedures and screenshots, please log in to the applicant’s window and download the “Operation Guide for Enterprise Electronic Filing Review and Correction” for operation.
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After The ERPS System Is Launched, How Can I Submit Supplementary Materials For Review And Registration Through Offline Channels?
After the eRPS system is launched, the administrative counterparts will still need to complete the review stage after receiving the supplementary materials through the offline channels. The supplementary information shall include paper information and electronic information. The paper materials shall be bound into a book, followed by a copy of the notice of correction data, a description of correction data, a list of correction data, and specific correction contents. The description of the revised information should clearly state the questions that need to be answered. The order of the corrections should be consistent with the order of questions raised in the notification of corrections, and should be corrected one by one without omission. Separate sheets of each correction material with separate sheets, and compile the page numbers in the order required by the notification of correction materials, in duplicate, with the official seal. The electronic version of the data should be stored in a USB flash drive, followed by the supplementary data folder, the supplementary data folder in a ZIP format, no password compression package, and a declaration of conformity. The supplementary materials folder should include a supplementary RPS information directory for specific supplementary content, supplementary information descriptions, and word documents submitted concurrently. The declaration of conformity shall be a scanned copy of the declaration of conformity of the printed and ele
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What Is The Definition And Construction Principle Of The Target Value In The Design Of Single-group Target Value Clinical Trials?
The target value is the recognized minimum criteria of the effectiveness/safety evaluation indexes for certain types of medical devices, including objective performance criteria (OPC) and performance goal (PG). The target value is usually a two-category (such as valid/invalid) indicator or a quantitative indicator, including the target value and the one-sided confidence interval limit (usually 97.5%). In a single-group clinical trial, the effectiveness/safety of the device in question is evaluated by examining whether the results of the main evaluation indicators are within the range of target value. Thus, a clinically meaningful target values needs to specify in advance. Because there is no control group, a single-group target value design clinical trial cannot confirm the superiority, equivalent, or non-inferiority of the device in question. It can only confirm that the effectiveness/safety of the device in question meets the recognized minimum criteria. The construction of target values usually requires comprehensive collection of clinical research data with a certain level of quality and a considerable number of cases, and scientific analysis (such as Meta analysis). With the improvement of device technology and clinical skills, OPC may change, and clinical data needs to be re-analyzed to confirm. When considering statistical analysis, the point estimates and the one-sided confidence interval limits for the primary evaluation indicators need to be calculated and compared
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What Should I Pay Attention To When Uploading PDF Files?
As far as possible, the applicant should control the PDF file of a single electronic registration report within 100MB, and multiple PDF files can be uploaded under the same directory title. It is recommended that the reading order of the materials under this title be reflected by the file name. For online submission, PDF files need to be signed by the CA signature of the company and successfully verified by the eRPS system before uploading automatically.
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What Are The Principles For Selecting Devices For Control Group In Parallel Controlled Clinical Trials?
For the therapeutic products, when selecting the positive control, it is preferred to choose approved similar devices that have clinically recognized efficacy and safety. If there are reasonable grounds that cannot select an approved similar device, then firstly, an approved device which is as similar to the device in question as possible can be chose as a positive control. Secondly, the standard treatment methods can be considered, which include multiple situations, such as medications. When the test device does not have the same or similar marketed products or corresponding standard treatment methods, the trial design needs to consider the comfort control if there is a comfort effect in the efficacy of the test device. At this time, ethical factors need to be considered comprehensively. If the efficacy of the marketed product has not been clinically recognized, the trial design can consider standard treatment methods or comfort control according to the specific situation, and the administrative counterparts should fully justify the selection of the control.
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How To Understand The Suggestions About Font Size In The Materials In The “Technical Guide For Electronic Submission Of Medical Device Registration Applications (Trial)”?
The technical guide describes the layout format including the font size, such as the font size is not less than four characters, the form text is not less than five characters, etc., which is only as a recommendation. The administrative counterpart should ensure that the electronic information submitted is clear and readable. If the format requirements for some materials are specified in the relevant guidelines, the corresponding requirements shall be complied with in the preparation of such materials.
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Does The Approval Of The Clinical Trial Application Also Approve The Clinical Trial Plan?
The aim of the clinical trial approval for class HI of high- risk medical device is to make a decision on whether to agree to conduct a clinical trial based on the application. The purpose is to protect the rights and interests of the subjects. The review focuses on preclinical research, clinical benefit and risk analysis of the product. The design of clinical schemes may affect the risks and benefits of clinical trials to subjects. Therefore, clinical trial plans are one of the review contents of clinical trial approval applications. However, the clinical trial approval process does not finalize the clinical trial plan submitted by the administrative counterpart. The administrative counterpart can refer to the communication with the review and approval personnel during the clinical device approval and registration process of the medical device, and modify and improve the clinical trial plan in accordance with the requirements of the GCP. The technical review agency will give a comprehensive evaluation of the safety and effectiveness of the product in the subsequent review and approval process.
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How To Add Page Numbers To Documents In ERPS System?
The page number of a single PDF file should have the correct and unique identification, to ensure that relevant information can be located through the page number. Each PDF file should be paged. The page number is recommended to reflect the directory number information where it is located. It should be clear and legible, and it is recommended to be in the middle of the bottom of the file. PDF files created after scanning can be paged by marking page numbers on paper.
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Whether A Similar Device Can Be Chosen As A Control Product In A Parallel Controlled Clinical Trial?
When conducting parallel controlled clinical trials, if a similar product already on the market cannot be used as a control product for reasonable reasons, product design characteristics, preclinical trial research results, risk and benefit analysis, clinical trial objectives, clinical trial evaluation indicators, and follow-up time may be considered in a comprehensive manner to select similar products that have been recognized for their efficacy and safety, the same scope of application as test equipment, and similar clinical evaluation indicators with test equipment as control products.
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When Calculating The Sample Size Of Diagnostic Devices In Clinical Trials, Can We Refer To “Guidelines For Design Of Clinical Trials Of Medical Devices”?
Yes, the scope of the “Guidelines for Design of Clinical Trials of Medical Devices” is clearly state that this guideline applies to medical devices that have been finalized in product composition, design, and performance, including therapeutic products, diagnostic products, excluding in vitro diagnostic reagents (IVDs). Therefore, diagnostic devices can refer to the relevant requirements in this guideline when calculating the sample size for clinical trial design.
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Can The Applicant Choose A Typical Model Of Devices To Conduct A Clinical Trial If There Are Multiple Models In One Registry Unit?
The typical model(s) can be selected to conduct clinical trials. For other models without clinical trials, the identities and differences between other models and typical models should be detailed, and the evidence of clinical safety and effectiveness of the selected typical model products can be extrapolated to all models of products in question.
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