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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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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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Whether Overseas Clinical Trial Data Only Can Be Accepted When Chinese Subjects Were Enrolled?
Data from Chinese subjects is not compulsory when considering if the overseas clinical trial data of a medical device is acceptable. But the administrative counterpart should confirm that the population data studied can be extrapolated to the Chinese population. According to the “Guidelines for the Acceptance of Data from Overseas Clinical Trials of Medical Devices", the factors that may affect the results of clinical trials are not limited to ethnic differences. The factors of differences in the population and the conditions of clinical trials need to be comprehensively considered based on product characteristics. Although it is already known that such factors exist objectively and may have some influence on the clinical trial, the influence degree of such factors shall be judged in combination with the characteristics of the medical device under application and the purpose of the clinical trial. When it is determined that such factors have no actual clinically significant influence on the clinical trial data of most medical devices according to the development status, the experience in clinical application as well as the cognition of related diseases and diagnosis and treatment methods, it is not required to prove them one by one. When it is determined that or it is hard to determine whether some factors have clinically significant influence on the clinical trial data, the applicant shall explain the methods taken to reduce or eliminate the influence of each difference. For
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Whether Medical Devices Listed In “The Catalog Of Class III Medical Devices That Needs Approval For Clinical Trial Conduction” Must Conduct Clinical Trials In China?
Medical devices listed in the “The Catalog of Class III Medical Devices that Needs Approval for Clinical Trial Conduction" also can submit overseas clinical trial data in accordance with the requirements in “Guidelines for the Acceptance of Data from Overseas Clinical Trials of Medical Devices". If the overseas clinical trial data is scientific, complete, sufficient and conforms to the requirements of Chinese regulatory based on ethical principles, legal principles, and scientific principles, no more clinical trials will require to conduct in China.
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Whether The Overseas Clinical Trial Data Must Meet The Requirements Of The Chinese Guidelines Of Specific Products?
There maybe differences for requirements of medical device clinical trial data in different countries. For example, for the design of a clinical trial, the requirement in some countries is that the clinical trial can reach the conclusion that the performance of a medical device achieves one observation endpoint. But the requirement for registration application in our country is that the effectiveness can only be verified until the performance of a medical device achieves multiple observation endpoints and there is appropriate evidence supporting the safety of the medical device. Therefore, the overseas clinical trial data may not fully meet the relevant review requirements in China. If the “guidelines for technical review of a specific medical device” issued by NMPA specified relevant requirements for the clinical trial of the medical device, such requirements shall be considered for the overseas clinical trial of the medical device. In case of any inconsistency, sufficient and reasonable grounds and basis shall be provided.
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Whether All The Comparing Items Listed In The “Guidelines For Clinical Evaluation Of Medical Devices” Need To Be Done When Conducting Clinical Evaluation By The Method Of Using Comparable Device(s)?
The “Guidelines for the Clinical Evaluation of Medical Devices” mentions that "the items to be compared with each comparable medical device shall include but not be limited to the items listed in Appendix 2." It’s also mentioned that “the reasons need to be state clearly if not applicable”. Appendix 2 lists items including basic principles, safety standards, national/industry standards, and intended use. The design characteristics of the products, key technologies, intended use, and extent of the risks need to be fully considered, and choose applicable items and explain its reasons when administrative counterpart conducting comparation. For example, an ultrasonic physiotherapy equipment should take the items including device structures, basic principles, main performance indicators, key components (mainly refers to probes or treatment heads), intended use, etc., into consideration. For the items such as manufacturing technique, use methods, etc., the impact of manufacturing technique on the safety and effectiveness of the product can be evaluated by comparison with other items. The use methods are basically same between similar products, so comparison of these two items is not required.
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What Clinical Data Sources Can Be Used Except The Source From Literature Of Comparable Medical Devices?
Other than clinical data from literature, the clinical data of comparable devices also include the data source from clinical experience and clinical trials. The clinical experience data includes completed clinical research data sets, adverse event data sets, and clinical risk-related corrective action data sets. The adverse event data set can be acquired from post-market complaints and adverse events published by regulatory agencies. The collection, analysis and evaluation of clinical data of comparable medical devices should include: Confirming whether the safety and effectiveness of the chosen comparable medical devices have been clinically recognized and whether its risks and benefits are acceptable; Fully identify the risks of clinical use of the comparable medical device(s), which can provide information for the risk-benefit analysis of the device in question; Confirm the residual risks of non-clinical research through clinical data; Provide clinical data for the evaluation of the test results of some non-clinical research (such as bench tests). In addition, the administrative counterpart also needs to confirm whether the safety and effectiveness of chosen comparable medical device(s) is widely used and recognized. And whether the literature search strategy is appropriate, as well as it can ensure the comprehensiveness of the search.
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Whether A Medical Device Can Use Its Own Clinical Data As The Clinical Data Of Comparable Devices When This Device Is Re-classified?
Yes. Its relevant pre-market and post-market clinical data should be fully collected when it was approved as previous class, and all data need to be summarized and analyzed scientifically. The main concerns are whether the device in question can achieve the expected performance under normal conditions of use; Whether the risks of the device are acceptable compared to its expected benefits; Whether the clinical performance and safety of the device are supported by appropriate evidence.
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