FAQ

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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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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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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According to the “Guidance for Clinical Evaluation of Medical Devices” (General Notice No. 14 of 2015), the requirements for conducting clinical evaluation by the method of using comparable device(s) is clear that the relevant data should be acquired legally. The “Notice of NMPA on Issuing Implementation of Provisions for Medical Devices and In Vitro Diagnostic Reagents Registration” (Food and Drug Administration [2015] No. 247) mentions that, if a device which belongs to another administrative counterpart is chosen as a comparable device, and the manufacturing technique information, clinical data and other information of comparable device(s) are used, the administrative counterpart need to submit an authorization when conducting clinical evaluation accordance with Article 6 of the “Guidance for Clinical Evaluation of Medical Device”. The “Interpretation Provisions for Medical Devices Registration No. 5”further interprets the medical device clinical evaluation data authorization requirements, which is, the authorization is required to ensure the legality of the data source when non-public data of comparable medical device(s) is used; The use of public publication data, such as published literature, public data and information, etc., authorization is not required. Therefore, when conducting clinical evaluation by the method of using comparable device(s), if the device(s) of other administrative counterpart is chosen as comparable medical device, and the data sources from publi

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The eRPS system introduces a digital certificate login method to ensure the uniqueness of user authentication for registered electronic filing and the security of data transmission. The login method of user name + password can realize the submission of electronic filing matters offline and the declaration of electronic filing matters that have not been opened yet (renewal of registration certificate and change documents, correction, self^cancellation, self-revocation, designated inspection of medical device registration). The digital certificate + password login method can realize the online submission and electronic document inspection of electronic declaration matters.

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On the basis of the existing progress inquiry method, the e-declaration matters are carried out through the eRPS system. The contact person filled in the application form of the matter can receive SMS and email status update reminders. In addition, corporate users can also log in to the eRPS system to see if the status of the item has been updated.

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According to Article 16 of the “Regulations on the Supervision and Administration of Medical Devices”,: For newly developed medical devices that have not been included in the catalogue, the administrative counterpart can directly apply for product registration in accordance with the provisions of these regulations regarding the registration of III medical device products. Alternatively, after judging the product category according to the classification rules and applying to the drug regulatory department for category confirmation, the administrative counterpart can apply for registration or filing in accordance with the provisions of these regulations.

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It is recommended to use PDF files formed from source files (such as WORDAVPS files) as much as possible. For example, WORD files can be converted to PDF format. If the registration application materials contain documents that cannot be accessed from electronic sources or require a third-party signature, this part of the materials can be submitted as PDF files created by scanning paper documents.

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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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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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If the applicant can prove that the different individual test items do not interact with each other in the joint detection reagent and the intended use does not exceed the scope of the exemption catalogue, it can be considered the multi-analyte joint detection reagent is just a simple joint of several exempted reagents, and the performance of each test item can be evaluated separately in accordance with the clinical evaluation requirements as the product of the Catalogue. It is worth noting that the applicant should confirm that these test items have a clear significance of joint testing and the additional risks produced by the combination should be evaluated. At the same time, if it has a new clinical significance, the multi-analyte joint detection reagent should not be considered a product that complies with the Catalogue.

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