When a product already has clinical trial data from overseas, and there are clinical trial guidance principles for corresponding products published domestically, does the overseas clinical trial data need to fully meet the domestic guidance principles?
Clinical trials conducted overseas may meet the technical evaluation requirements of the country (region) where the trial is conducted, but may not necessarily fully comply with the relevant evaluation requirements in China. For example, when designing clinical trials, some countries may only require the trial to conclude that the device's performance reaches a certain observational endpoint. However, in China, it may be necessary for the device's performance to meet multiple observational endpoints to confirm its effectiveness, with appropriate evidence supporting the device's safety. If the National Medical Products Administration issues specific technical evaluation guidance principles for a particular medical device that include requirements for its clinical trials, the overseas clinical trials of that device should consider these requirements. In case of any inconsistencies, sufficient and reasonable justifications and evidence should be provided.
When accepting overseas medical device clinical trial data, is it necessary for the overseas clinical trial data to include data from Chinese subjects?
When accepting overseas medical device clinical trial data, it is not always necessary for the data to include data from Chinese subjects. According to the "Guiding Principles for Accepting Overseas Medical Device Clinical Trial Data," factors that may affect the clinical trial results are not limited to ethnic differences. It is necessary to consider the impact of differences in the tested population and clinical trial conditions based on the product characteristics. Although these factors objectively exist and have a certain impact on clinical trials, the determination of the degree of influence of each factor should also consider the characteristics of the device to be applied for and the objectives of the clinical trial. In situations where it can be determined that the impact of certain factors on the clinical trial data of most medical devices is not clinically significant based on the current status of medical device development, clinical experience, and understanding of relevant diseases and treatment methods, individual verification may not be required. When it can be determined that certain factors have a clinically significant impact on the clinical trial data, or when it is difficult to determine whether certain factors have a clinically significant impact on the clinical trial data, the applicant should clarify the methods used to reduce or eliminate the impact of each difference, such as considering subgroup design for the tested population or conducting subgroup analysis on existing clinical trial data as needed.
Do medical devices listed in the "Catalog of Class III Medical Devices Requiring Clinical Trial Approval" need to conduct clinical trials in China?
According to the "Technical Guidance Principles for Accepting Overseas Medical Device Clinical Trial Data," medical devices listed in the "Catalog of Class III Medical Devices Requiring Clinical Trial Approval" can submit overseas clinical trial data based on this guidance. Following ethical, legal, and scientific principles, if overseas clinical trial data meets China's registration-related technical requirements and is scientifically sound, complete, and sufficient, clinical trials do not need to be conducted in China.
When conducting clinical trials for in vitro diagnostic reagents and using sequencing methods as a comparative method, what clinical data should be provided for the sequencing method?
1. Informational Content: When using sequencing methods, the clinical trial data should include relevant information about the sequencing method. 1.1 Information such as the principles of the sequencing method, the model of the sequencing instrument, and information about sequencing reagents and consumables should be provided. 1.2 Information related to the primers used in the sequencing method, such as gene segment selection, molecular weight, purity, functional experiments, etc., should be provided. The primer design should reasonably cover the target nucleic acid segments, sites for amplification of the test reagent, and all types of mutations. 2. Methodological Validation Information 2.1 Reasonable validation of the analytical performance of the selected sequencing method, especially confirmation of the lowest detection limit, is recommended. It is suggested to appropriately compare the selected sequencing method with the relevant performance of the test reagent. 2.2 A reasonable positive quality control and negative quality control should be established for the sequencing method to control the quality of the detection results of clinical samples. 3. Sequencing Result Information In addition to the sequencing results in the result data table, representative sample sequencing chromatograms and result analysis data should be submitted.
How should the registration units of dental etchants be divided?
Dental etchants are used for intraoral repair or orthodontic treatment, where the corrosive nature of the etchant is used to treat the surfaces of teeth, metals, ceramics, and other restorative materials to remove contamination layers, rough surfaces, and improve their surface performance. Products with different main chemical components should be divided into different registration units, for example, phosphoric acid etchants and citric acid etchants should be separate registration units.
Do medical optical endoscopes and laser fibers need electromagnetic compatibility testing?
If medical optical endoscopes and laser fibers do not contain electronic components inside, only optical components, then they do not need electromagnetic compatibility testing. If they contain electronic components inside (such as RFID recognition devices), then electromagnetic compatibility testing is required.
When conducting microbial invasion tests on needleless connector products, how should the test microbes be selected?
Microbial invasion tests should simulate repeated clinical use. The types and quantities of microbes used in the test should be similar to the potential infecting microbes at the entry site of medical devices used clinically. It is recommended to use 2 types of Gram-negative bacteria and 2 types of Gram-positive bacteria, with at least 1 type of each. The selected microbes for the test should be common microbes that cause infusion-related infections in clinical settings. Reference can be made to the "Guidelines for the Prevention and Treatment of Catheter-Related Infections" (issued by the Chinese Society of Critical Care Medicine) for selection.
Are pyrogens and bacterial endotoxins the same?
Pyrogens refer to substances that can cause fever in the body, including information on materials causing fever and bacterial endotoxin-induced fever, which are part of biological evaluation projects. Bacterial endotoxins are lipid polysaccharide components released from the cell wall of Gram-negative bacteria after death and autolysis, typically originating from biological contamination introduced during production, and are not part of biological evaluation projects. Generally, bacterial endotoxins are pyrogens, but not all pyrogens are bacterial endotoxins.
When conducting electromagnetic compatibility testing on active products, is it necessary to test together with the passive accessories in the product composition?
Typically, all accessories in the equipment, cable layout, and typical configurations used in electromagnetic compatibility testing should be consistent with normal use. If it is determined through analysis that the passive accessories are not relevant to electromagnetic compatibility testing, then there is no need to test them along with the passive accessories. However, if testing with the passive accessories is necessary to achieve its basic performance, then the testing should be done with those passive accessories.
Do the reagent batches used in clinical trials of in vitro diagnostic reagents need to be inspection batches, and do they need to be from the same batch?
After the reagents intended for registration have passed inspection, they can be used for clinical trials with either inspection batches or non-inspection batches. The reagent batch numbers used by each institution should be clearly stated in the clinical trial report. If the clinical trial duration is long, multiple batches can be used based on actual circumstances. However, it is important to note that the reagents used in clinical trials, registration inspections, and preclinical studies of in vitro diagnostic reagents should be produced under conditions that comply with the medical device quality management system, and the production quantity of the batch should be sufficient. For domestic products, if the batches used in clinical trials, registration inspections, and preclinical studies are different, the reasons and specific details of the production batches should be explained.