Sixth, through the same variety of medical devices clinical trials or clinical use of data obtained by analyzing and evaluating the requirements
(a) the same variety of medical devices
1. Definition of the same varieties of medical devices
Same varieties of medical devices refers to the same varieties of medical devices with the declared products in terms of basic principles, structural composition, manufacturing materials (active products for the part in contact with the human body), and the same varieties of medical devices.
The same variety of medical device means a product that has been approved for domestic registration with the declared product in terms of basic principles, structural composition, manufacturing materials (active products for the human body in contact with the part of the manufacturing materials), production process, performance requirements, safety evaluation, compliance with national/industry standards, intended use and other aspects of the product is basically the same.
Differences between the declared product and the same variety of medical devices do not adversely affect the safety and effectiveness of the product can be regarded as basically equivalent.
2. The determination of the same variety of medical devices
Applicants for registration through clinical trials of the same variety of medical devices or clinical use of data obtained by analyzing and evaluating the proof of safety and effectiveness of medical devices, you need to first declare the product and one or more of the same varieties of medical devices to be compared, to prove that the two are basically equivalent.
The items to be compared with each of the same variety of medical devices should include, but not limited to, the items listed in Attachment 2, the comparison includes qualitative and quantitative data, verification and confirmation of the results, should be described in detail the similarity and differences between the two, on the differences of whether the safety and effectiveness of the product has an adverse effect on the product should be verified by the declared product's own data and/or confirmation, such as declaring the product's nonclinical Research data, clinical literature data, clinical experience data, and data from clinical trials conducted in China on the differences. The collection, analysis and evaluation of the corresponding data shall comply with the requirements of items (3) and (4) of this part and the corresponding annexes. Clinical trials shall comply with the relevant requirements of the Code for Quality Management of Clinical Trials.
The applicant for registration shall provide comparative information in the form of a list (see Attachment 3 for format). If there are non-applicable items, the reasons for non-applicability should be stated.
(B) Evaluation path
Specific evaluation path is shown in Attachment 4.
(C) the collection of data obtained from clinical trials or clinical use of the same variety of medical devices
Data obtained from clinical trials or clinical use (hereinafter referred to as clinical data) can be from the publicly available scientific literature in China and/or abroad and legally available corresponding data, including Clinical literature data, clinical experience data. The applicant for registration may choose the appropriate data sources and collection methods according to the specific circumstances of the product.
1. Collection of Clinical Literature Data
Collection of clinical literature data should ensure accurate and complete literature search. The elements of literature search and screening are shown in Attachment 5. A literature search and screening program (see Attachment 6 for content and format) needs to be developed before the literature search is conducted. After the literature search and screening is completed, a literature search and screening report should be prepared (see Appendix 7 for content and format). The search and screening of clinical literature should be reproducible. Literature search and screening personnel should have appropriate professional knowledge and practical experience.
2. Collection of clinical experience data
The collection of clinical experience data should include the collection of data on completed clinical studies, adverse events, and corrective measures related to clinical risks.
(1) Data collection of completed clinical studies
By the type of design of clinical studies, they can be divided into prospective studies, retrospective studies, randomized controlled studies, non-randomized controlled studies, single-group studies, and case reports.
Registration applicants are required to collect and provide ethics committee opinions (if applicable), clinical study protocols and clinical study reports.
(2) Adverse event data collection
The registration applicant shall collect, including the complaint and adverse event database established by the registration applicant, as well as the corresponding adverse event data in the adverse event database issued by the regulatory bodies of various countries, such as the Medical Device Adverse Event Information Bulletin and Medical Device Alert Alert issued by the State Food and Drug Administration (SFDA), and the U.S. Food and Drug Administration (MAUDE), the Medical Device Alert (MDA), and so on.
Applicants for registration are required to provide information on the number of complaints and adverse events for the same type of medical device, the cause of the complaints and adverse events categorized, the number of complaints and adverse events for each category of cause, and whether the complaints and adverse events are related to the product. For serious adverse events, should be provided in the form of a list of event description, cause analysis, treatment and other specific information.
For the declared products, it is also necessary to provide specific information such as when the product was marketed in each country, the cumulative sales volume, and the results of the treatment of serious adverse events.
(3) the collection of data on corrective measures related to clinical risk
Applicants for registration should collect and provide specific information on corrective measures (such as recalls, announcements, warnings, etc.) related to clinical risk of the same variety of medical devices, and information on the risk control measures taken.
(D) the same variety of medical devices clinical data analysis and evaluation
1. Quality evaluation of data
Applicants for registration should be included in the analysis of the data in accordance with recognized standards for evaluating the level of clinical evidence (such as Oxford Center for Evidence-Based Medicine developed by the level of evaluation of the level of clinical evidence standards, etc.) for grading. Some of the clinical data that are not suitable for product effectiveness evaluation may be used for product safety evaluation, if applicable.
2. Establishment of datasets
Depending on the type and quality of the data, the collected clinical data can be grouped into multiple datasets. The applicant for registration may also establish separate datasets for different evaluation purposes. For example, if there are ethnic differences in the clinical performance and/or safety of certain products, a dataset for the Chinese population may be established to evaluate the safety and/or efficacy of the product in the Chinese population.
3. Statistical analysis of data
Selecting appropriate data analysis methods for different data sets is necessary. The analysis methods for data sets consisting of multiple research findings include qualitative and quantitative analysis.
4. Data Evaluation
Combining the analysis results of different data sets, the declared products are evaluated to see whether the products can achieve the expected performance under normal use conditions; and whether the risks of the products are acceptable compared with the expected benefits.
(E) Clinical Evaluation Report
A clinical evaluation report is required to be written after completion of the clinical evaluation (format attached as Appendix 8), and submitted as a clinical evaluation data in the registration application.
VII. Clinical trial requirements
For medical devices undergoing clinical trials in China, the clinical trials should be conducted in qualified clinical trial organizations in accordance with the requirements of the Code for Quality Management of Clinical Trials for Medical Devices. The applicant for registration shall submit the clinical trial program and clinical trial report at the time of registration declaration.
For imported medical devices undergoing clinical trials outside China, if the clinical trial meets the requirements of the relevant Chinese regulations, the corresponding technical requirements in the technical guidelines for registration, such as the sample size, the selection of the control group, the evaluation indexes and principles of evaluation, and efficacy evaluation indexes, the applicant for registration in the registration application can submit the clinical trial information submitted to the competent authority of the foreign medical device when it is listed in the market outside China. The information should at least include the opinion of the Ethics Committee, clinical trial program and clinical trial report, the applicant is also required to submit supporting information to demonstrate that the clinical performance and/or safety of the product is ethnically different.
The medical devices listed in the "Catalog of Class III Medical Devices Requiring Clinical Trial Approval" should be subject to clinical trials in China.
Attachment: 1. Comparison table of declared products with the catalog of medical devices that have been approved for domestic registration
2. Comparison of declared products with medical devices of the same species
3. Comparison table of declared products with medical devices of the same species in the format
4. Analysis of the data obtained through the clinical trials of the medical devices of the same species or the clinical use of the data
Data Evaluation pathway
5. Literature search and screening requirements
6. Literature search and screening program
7. Literature search and screening report
8. Analysis and evaluation of data obtained through clinical trials or clinical use of the same varieties of medical devices
Data evaluation report