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.
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.
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
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.
For the therapeutic products, when selecting the positive control, it is preferred to choose approved similar devices that have clinically recognized efficacy and safety. If there are reasonable grounds that cannot select an approved similar device, then firstly, an approved device which is as similar to the device in question as possible can be chose as a positive control. Secondly, the standard treatment methods can be considered, which include multiple situations, such as medications. When the test device does not have the same or similar marketed products or corresponding standard treatment methods, the trial design needs to consider the comfort control if there is a comfort effect in the efficacy of the test device. At this time, ethical factors need to be considered comprehensively. If the efficacy of the marketed product has not been clinically recognized, the trial design can consider standard treatment methods or comfort control according to the specific situation, and the administrative counterparts should fully justify the selection of the control.
The technical guide describes the layout format including the font size, such as the font size is not less than four characters, the form text is not less than five characters, etc., which is only as a recommendation. The administrative counterpart should ensure that the electronic information submitted is clear and readable. If the format requirements for some materials are specified in the relevant guidelines, the corresponding requirements shall be complied with in the preparation of such materials.
The aim of the clinical trial approval for class HI of high- risk medical device is to make a decision on whether to agree to conduct a clinical trial based on the application. The purpose is to protect the rights and interests of the subjects. The review focuses on preclinical research, clinical benefit and risk analysis of the product. The design of clinical schemes may affect the risks and benefits of clinical trials to subjects. Therefore, clinical trial plans are one of the review contents of clinical trial approval applications. However, the clinical trial approval process does not finalize the clinical trial plan submitted by the administrative counterpart. The administrative counterpart can refer to the communication with the review and approval personnel during the clinical device approval and registration process of the medical device, and modify and improve the clinical trial plan in accordance with the requirements of the GCP. The technical review agency will give a comprehensive evaluation of the safety and effectiveness of the product in the subsequent review and approval process.
The page number of a single PDF file should have the correct and unique identification, to ensure that relevant information can be located through the page number. Each PDF file should be paged. The page number is recommended to reflect the directory number information where it is located. It should be clear and legible, and it is recommended to be in the middle of the bottom of the file. PDF files created after scanning can be paged by marking page numbers on paper.
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.
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.
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.
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.