1. Basic principles

Clinical evaluation based on clinical data of the same type of medical device should be comprehensive and objective, and the collected clinical performance and safety data, as well as favorable and unfavorable data, should be included in the analysis. The depth and breadth of clinical evaluation, the type and amount of data required, should be appropriate to the product design, key technologies, expected use, and risk level, as well as to the level and degree of non clinical research. The evidence strength of clinical data for the same type of medical device should not be lower than that obtained from clinical trials.

Clinical evaluation should confirm the scope of application of the product (such as applicable population, applicable site, contact with the human body, indications, degree and stage of disease, usage environment, etc.), usage methods, contraindications, preventive measures, warnings, and other clinical usage information. The applicant for registration should draw the following conclusion through clinical evaluation: under normal usage conditions, the product can achieve the expected performance; Compared to the expected benefits, the risk of the product is acceptable; The performance and safety of the product can be supported by appropriate evidence.

When the safety and efficacy evaluation of the product cannot be conducted based on existing clinical data, the registration applicant needs to conduct clinical trials within China in accordance with relevant regulations.

2. Comparison and judgment of medical devices of the same variety

2.1 Definition of medical devices of the same variety

Medical devices of the same variety (excluding in vitro diagnostic medical devices) refer to products that have been listed in China and are equivalent to the declared product in terms of basic principles, structural composition, manufacturing materials (active products are manufacturing materials that come into contact with the human body), production processes, performance requirements, safety evaluation, compliance with standards, and expected use.

In vitro diagnostic medical devices of the same variety refer to products that have been launched in China and have similarities in terms of method principles, product design, structural functions, performance characteristics, and scope of application.

2.2 Comparison and judgment of medical devices of the same variety

When the applicant for registration conducts clinical evaluation of the declared product based on clinical data of the same type of medical device, they need to demonstrate the equivalence between the declared product and the same type of product. Compare the declared products with products of the same variety, and elaborate on the similarities and differences between the two. The comparison items should include but are not limited to the items listed in Annex 2, and the comparison content includes qualitative and quantitative data, validation and confirmation results. Suggest providing comparative information in the form of a list (see Attachment 3 for format). For specific products, if there are items that are not applicable, the reasons for their non applicability should be explained. When the differences between the declared product and products of the same variety have no impact on the safety and effectiveness of the declared product, it is considered that the two are equivalent. The differences between declared products and products of the same variety can be verified and/or confirmed through non clinical studies and/or clinical trials conducted within China to determine their safety and effectiveness.

3. Evaluation path

Different evaluation paths are set based on whether the equivalence between the declared product and the same variety of product needs to be verified and/or confirmed through non clinical studies and/or clinical trials, and whether clinical evaluation based on existing clinical data is sufficient. The specific evaluation path can be found in Attachment 4.

4. Collection of clinical data for medical devices of the same variety

Registration applicants can conduct clinical evaluations using clinical data of the same type of medical device legally obtained within and outside China. Clinical data can come from publicly available scientific literature and clinical experience data. This clause provides suggestions for the collection of clinical data on medical devices of the same variety. The registration applicant may choose appropriate data sources and collection methods based on the specific situation of the product. The collected clinical data should fully meet the needs of product safety and efficacy evaluation.

4.1 Collection of clinical literature data

When using literature data for clinical evaluation, the accuracy and completeness of literature are closely related to the reliability and comprehensiveness of clinical data. Suggested literature search and screening elements to consider can be found in Attachment 5. Before conducting literature search, it is necessary to develop a literature search and screening plan (see Annex 6 for content and format). After the literature search and screening are completed, a literature search and screening report (see Annex 7 for content and format) needs to be prepared. The retrieval and screening of clinical literature should have reproducibility. Literature search and screening personnel should have corresponding professional knowledge and practical experience.

4.2 Collection of clinical experience data

4.2.1 Completed clinical studies

According to the design type of clinical research, it can be divided into prospective studies, retrospective studies, randomized controlled studies, non randomized controlled studies, single group studies, case reports, etc. The applicant for registration needs to provide an ethics committee opinion (if applicable), clinical research protocol, and clinical research report.