When registering for blood dialysis concentrates, what are the key points of focus in the product testing report?
1. Pay attention to the final ion concentration of the dialysate, the components and proportions of the chemical raw materials in the AB agent, the status of the dialysis concentrate provision, and the ratio of concentrate to dialysis water. If there is any difference in the above four aspects, a comprehensive registration testing report should be provided for each. 2. If the product is provided in concentrated liquid form, provide a full-item registration test report that complies with the YY 0572 standard for dialysis water used in production. 3. When applying for online use of B powder according to the instructions for use on applicable machine types, provide registration test reports in different packaging forms based on clinical usage. This should include at least four time points (at the start of dialysis, at three equally spaced clinical usage time points, and at the end of dialysis) and registration test reports related to the dialysate formation with the A agent.
What issues should be considered in electromagnetic compatibility testing-Typicality of Multiple Models and Accessories
All products within the declared registration unit (including all models and components) should be submitted as samples. These samples can either all undergo testing or be analyzed by the inspecting engineers at the testing center, who will select representative samples for testing. The electromagnetic compatibility test report should clearly state the information of the submitted and tested products. The conclusion of the electromagnetic compatibility test report should specify whether the submitted products meet the electromagnetic compatibility requirements and standards. For certain accessories included with the samples, if they are deemed irrelevant to the electromagnetic compatibility test by the inspecting engineers, the report should clearly mention these accessories and the analysis conclusion. The information of these accessories does not need to be included in the sample composition table.
What issues should be considered in electromagnetic compatibility testing-Relevance of Inspection Reports
The electromagnetic compatibility test report should be correlated with the electrical safety inspection report to ensure the consistency of the samples being tested.
What aspects should be noted for the registration unit of metal cable, cable system products?
Metal cables and cable systems are used for internal fixation of limb fractures, with the structure detailed in YY/T 0812. Products with different constituent materials (including material grades) are categorized into separate registration units. Based on the commonly used metal materials for the main components of cables and cable systems, registration units can include TC4 titanium alloy, TC4ELI titanium alloy, TC20 titanium alloy, 00Cr18Ni14Mo3 stainless steel, cobalt-chromium-tungsten-nickel alloy, and others. Metal components used in conjunction with metal cables and cable systems, such as locks, can be categorized under the same registration unit if the constituent materials differ but are used as an integrated assembly or combination. Metal cables, cable systems, and flexible metal wires fall under different registration units.
Can the endoscope camera system be in the same registration unit as the endoscope?
Whether it's a specialized or a general-purpose endoscope camera system, they should be classified into separate registration units from the endoscope.
In how many registration units are intramedullary nail products divided?
1. Based on the fixation mechanism, they can be divided into two registration units: intramedullary nails with locks and intramedullary nails without locks, with structures detailed in YY/T 0727.1 and YY/T 0019.1. Intramedullary nail products have a different structure from intramedullary needle products and belong to different registration units. 2. With different constituent materials (including material grades), they are categorized into separate registration units. Based on the commonly used metal materials for intramedullary nails, they can be divided into TC4 titanium alloy, TC4ELI titanium alloy, TC20 titanium alloy, 00Cr18Ni14Mo3 stainless steel, and other registration units. If the constituent materials of the products differ but are used as an integrated assembly or combination, they can be declared under the same registration unit.
What issues should be considered in electromagnetic compatibility testing-Selection of Sample Operating Modes
The sample operating mode should identify the maximum emission operating mode. It should comprehensively and thoroughly identify the "functions" as defined in YY 0505-2012, conduct robustness testing for each identified function, and perform robustness testing in the least favorable manner for patient impact.
What issues should be considered in electromagnetic compatibility testing-Determination of Basic Performance
"Basic performance" refers to essential performance to achieve no unacceptable risks, considering whether its loss or reduction would lead to unacceptable risks. When determining the product's basic performance, the manufacturer should consider, but not limited to, the following aspects: analyzing clinical safety risks, considering performance related to diagnosis/treatment/monitoring, whether various sensors, cables, application parts, control devices, display units, moving parts, etc., are affected by electromagnetic interference. The basic performance identified in the relevant documents should be tested for robustness. If basic performance is not identified in the documents, all functions should be considered for robustness testing.
When a product is undergoing chemical performance research and an abnormality in a certain chemical property (such as reducing substances) is observed, how should it be evaluated?
When abnormal results are found in chemical performance studies, it is recommended that the applicant assess the reasons for the anomaly and evaluate the safety of the medical device comprehensively. For example, for catheter products with a coating, if the coating material causes abnormal results in the reducing substances test, it is suggested to test products without the coating to confirm if their chemical performance is acceptable. At the same time, consider the clinical application history of the coating material and biocompatibility data for a comprehensive evaluation.
For newly developed medical devices not yet included in the classification catalog, do they have to be classified before applying for registration?
According to Article 16 of the "Regulations on the Supervision and Management of Medical Devices": For newly developed medical devices not yet included in the classification catalog, applicants can directly apply for product registration in accordance with the provisions of this regulation on the registration of Class III medical device products. Alternatively, they can determine the product category based on the classification rules and apply to the State Food and Drug Administration department for category confirmation, and then apply for registration or product filing in accordance with the provisions of this regulation.