FAQ

The fatigue test and study of the intravascular stent should evaluate the ability of the stent to maintain long-term structural integrity under the worst simulated physiological load conditions, and should evaluate the stent durability under all relevant fatigue load modes of the stent, which should be determined based on the intended clinical use (e.g., implantation site) and conditions (e.g., expansion ratio and stent overlap).

When applying for the registration of dialysate concentrate for hemodialysis, the following should be concerned in the product test report:

1. As long as one of the following four factors is different, a full performance test report which comply with product technology requirement should be provided respectively: the final ion concentration of the dialysate, the composition and proportions of chemical raw materials of single agent of AB agents, the supply status of the dialysate concentrate, and the concentration ratio of the concentrate and the water for dialysis.
2. If the product is supplied as a concentrated liquid, a full performance test report of the dialysis water used in production which comply with (the Industry Standard) YY 0572 should be provided.
3. In the application for the online use of dry powder B, test report should be provided according to the applicable dialysis machine models specified in the IFU, different packaging forms provided as well as the clinical use. The reports should include the test reports for relevant indicators of the dialysate prepared by mixing with A agent at least four time points (at the beginning of dialysis, the two time points for three equal division of the clinical use duration, at the end of dialysis).

...

READ MORE >

It is preferred to select products that have been approved for registration in China and that are basically equivalent to the product under application in terms of basic principle, structural composition, manufacturing materials, manufacturing process, performance requirements, safety evaluation, complied national/ industry standards, intended use, etc. If there is no such basically equivalent product, a product that is as similar as possible should be selected. If it is not possible to use marketed similar products for reasonable reasons, it is allowed to choose products that have been widely used clinically and have proven and recognized efficacy for the corresponding indications.

For marketed animal-derived dental biomaterials, if there are changes in the geographical origins of animals, it is suggested to analyze whether the changes in geographical origins substantially affect the safety and effectiveness of the product, for example, the performance equivalence analysis and verification may be conducted for the materials obtained from different origins after treatment. If no effect is generated, the change process may be independently controlled through the change management process under the quality management system of administrative counterpart.

The cutting performance of the dental drill for implant can be divided into end cutting and side cutting. The administrative counterpart may select the applicable cutting performance test according to the functional characteristics of the dental drill. Except for the disposable sterile dental drill, the cutting test should be conducted after high temperature and high pressure steam sterilization, and consider the thermal effect of sterilization. The cutting test can be conducted with reference to the method specified in the annex of “Guidelines for Technical Review of the Registration of Drill for Dental Implantation Surgery". The average time for the dental drill to cut five holes in the end cutting test as well as the time for the dental drill to cut a distance five times of head diameter in the side cutting test may be independently specified by the administrative counterpart, but it is necessary to demonstrate that it can meet the needs for clinical use.

The administrative counterpart should submit the technical or supporting data that can effectively prove or explain the principle of hemostasis of the product under application, including but not limited to:

1. The administrative counterpart should elaborate the hemostatic mechanism of the product under application, describe how the product affects the hemostasis process and the advantages of the product in the hemostasis process, and confirm whether the application of the hemostatic mechanism combined with the product under application is scientific and reasonable.
2. The administrative counterpart should conduct a study on whether the product under application may cause adverse reactions related to its use, such as thrombosis and coagulopathy.
3. The administrative counterpart should submit a review of the domestic and foreign research literature supporting the principle of hemostasis, as well as the original and Chinese translations of relevant scientific literature specifically supporting the principle of hemostasis.
4. The administrative counterpart should indicate whether products with the same principle of hemostasis have been marketed at home and abroad.

During the in vitro degradation study of absorbable hemostatic products, it is recommended to simulate the in vivo conditions (e.g., 37°C environment, proteolysis, etc.) to study the time required for the product to be completely degraded and absorbed and all degradation products. And establish a reasonable in vitro degradation study method based on product characteristics and clinical application. And refer to existing standard methods and compare with similar marketed products. The recommended observation indicators for in vitro degradation study include: product solubility, degradation period, conditions required for degradation, and the relationship between degradation rate and degradation conditions, the main degradation products and their content, and morphological changes (disintegration process, whether there are fragments falling, swelling of fragments, etc.).

During clinical treatment, part of the purified blood will return to the inlet of the extracorporeal circuit, that is, blood will flow reversely from the venous end to the arterial end, and this part of the purified reverse blood flow constitutes access recirculation. Such vascular access recirculation not only affects dialysis efficacy but also interferes with the assessment of sufficiency of dialysis. The measurement, evaluation, and application of vascular access recirculation can guide clinicians to individualize the prescriptions for different dialysis patients. It also has important significance for guiding the measurement of vascular dysfunction and enhanced dialysis efficacy.

The administrative counterpart may develop the requirements for the hardness of components and cutting knives according to the clinical needs that the performance of the product should meet, and provide the basis for determining the hardness requirements as well as corresponding verification data. The requirements in the “Guidelines for the Technical Review of the Registration of Stapler Products”can be adopted, i.e., the components made of 20Cr13 material should be heat treated, with a hardness of 40HRC- 48HRC. The hardness of the cutting knives should not be less than 377HV0.2.

The success of restoration with implant denture largely depends on the shape, height, taper and material, appropriate number, reasonable distribution of abutments as well as the achievement of a common path of insertion. The basal part of abutment is connected to the implant by internal and external connections, and the upper end of abutment carries the upper restoration and provides it with retention and support. The personalise abutment is designed according to the specific circumstances of patients, which matches better with the anatomical shape and correction angle of patients. For this type of abutments, it is necessary to clarify the information on the shape, height, and taper that the abutment can be processed into. In addition, the implant-abutment connection surface determines the strength and stability during the application of the implant system. The irregularities and small gaps in implant-abutment connection may cause the loosening and breakage of screw as well as accumulation of bacteria at the implant-abutment connection, resulting in complications including peri-implantitis and bone resorption at implant neck. In order to control the interface accuracy, it is required to have CNC processing equipment and quality control capability. The contents for verification should at least include the Gt of internal connection taper, fit clearance, thread deviation, torsional resistance, tightening torque, edge clearance measurement study and fatig

...

When abnormal results are present in the study on chemical performance of non-active medical device products, it is recommended to evaluate the cause of the abnormal results and comprehensively evaluate the safety of the medical device. For example, for the coated catheter products, if the coating material causes abnormal test results of reducing substances, it is recommended to test the intermediate products of the product before coating to confirm whether the chemical performance test result is interfered by the coating. Meanwhile, the clinical application history and biocompatibility data of the coating material should be combined to comprehensive evaluate product safety.