common-faq

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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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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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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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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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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