FAQ

The administrative counterpart should evaluate the relevant performance of the primary packaging materials based on the effects of the product itself and the sterilization method on the primary packaging materials. It is recommended to consider primary packaging materials, packaging process, packaging methods, and compatibility of primary packaging materials with products as well as other aspects, such as product packaging integrity, packaging seal strength and similar performance evaluation which can affect resistance to bacteria during shelf life, whether there will be biochemical reactions between the packaging materials and the medical device, whether the reaction will affect the barrier properties of the packaging and/or the safety and effectiveness of the product, the challenges of the shape of the medical device to the primary packaging, etc.

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The shelf life of medical devices refers to the time limit during which the normal intended function of the final medical device product can be ensured. For the dental burs and drills supplied as sterile, the shelf life should be established. For the dental burs and drills not supplied as sterile, the shelf life may not be established, but it is recommended to make clear the usage times of the product in the IFU.

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Accelerated stability test refers to the test where a product is placed under external stress to examine the material degradation under the stress conditions, and infer the product degradation under normal storage conditions by using the relationship between the known accelerated factor and the degradation rate, so the storage and transportation conditions have a direct correlation with the shelf life, and it is thus necessary to limit the storage and transportation conditions of the product.

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In addition to the contents mentioned in the “Guidelines for the Registration Application Dossiers of Shelf Life of Non-active Implantable Medical Devices”, the shelf life verification of non­active implantable device products should ensure that the verified packaging materials, packaging methods and sample are consistent or representable with the final products released from the factory. During the design and development of the product, any changes to the above content should lead to re-verification. The shelf life of the product should be determined in consideration of the longest time that the product itself can maintain stable performance and the longest time that the package can maintain stable performance of the sterile barrier and packaging. In the quality system control, the product packaging materials, especially the primary packaging materials, should be controlled for microbial and particulate contamination.

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The administrative counterparts should perform quality control on raw materials and ensure compliance with the requirements of relevant standards for the materials. And they should also conduct studies on the mechanical properties of the main raw materials, and provide data proving that the raw materials selected can meet the needs of now control stability of products. For example, for components that provide mechanical power, study should be conducted on the elastic modulus, hardness, and deformation of the raw materials, and the control criteria and verification reports for the raw materials should be submitted. For the material of the flow-limiting device, it should be stated whether the hardness, elasticity and other characteristics of the material will affect the flow accuracy under the intended use environment (temperature, humidity, atmospheric pressure), and relevant research data should be provided.

For the raw material pellets developed and produced by the administrative counterpart, the administrative counterpart should provide a detailed formulation development report, including a verification report proving compliance with the requirements of relevant standards for the raw materials. If the administrative counterpart of the device is using outsourced pellets, the supplier should be required to submit a verification report proving that the raw materials meet the relevant standards for th

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The data to be provided for the mechanical performance study of orthopedic implants should include at least the following aspects: clearly define the mechanical performance study items that should be carried out to ensure that the performance of the device can meet clinical needs, and provided the reason for selecting the above study items. The study items should fully ensure the performance and use of the device as expected. For each mechanical performance item, a corresponding test method should be specified, which can be selected from test methods in existing standards; if other methods are used, their rationality and equivalence should be explained. The selection of test samples should be representative of the worst conditions for the performance of the product under application, and the basis for determining them as the worst conditions should be provided. The test data and results should be processed and analyzed and the test results should be demonstrated that the product can meet the needs of clinical use.

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Artificial joint products are usually used as a whole to replace human joints. When the product registration contains only a single component, in addition to evaluating the performance of the component, it is also necessary to provide the product information of other components used in conjunction with the component under application, and evaluate through studies the performance of the interaction between the component under application and the cooperating component and the performance of the system as a whole. Take the artificial hip joint system as an example, if the product registration is for femoral stem, performance study data of the femoral head matched with it should be provided at least. If the product registration is for the acetabular liner, performance study data of the acetabular cup and femoral head matched with it should be provided at least; as it is related to the articular surface, the overall wear performance study of the system should be provided.

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It is recommended to define the mechanical loading mode and number of fatigue cycle loads of the fatigue test based on the product structural characteristics and intended use, and provide the basis for determining the rationality of the design. The initial fatigue load should be determined based on the static ultimate strength in the corresponding static test. It may be considered that at 75%, 50%, and 25% of the static ultimate strength and under the specified fatigue loading mode and the number of fatigue cycle loads, the sample is deemed to have passed the test if it passes the test without any failure. When determining the fatigue limits, at least the difference between the fatigue limit value and the load causing the structural failure should be guaranteed to be less than 10% of the static ultimate strength, and the number of samples considered pass under this fatigue limit is greater than 1.

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The finite element analysis tool is usually used to determine the worst cases of a product's performance. Therefore, it is necessary to clarify the purpose of using the finite element analysis and the evaluation indicators for the analysis results. The finite element model should be able to represent all models and specifications of the product under application. At the creation of the finite element model, the rationality of the model creation should be ensured, such as the simplified operation during the model creation process, the parameter settings of each step, etc. The finite element model should be verified to ensure the reliability of the finite element results. During results analysis, it should be considered whether the difference in results of different models and specifications can reflect the difference in performance.

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The final cleaning process of metal orthopedic implants should be designed in accordance with the product structure and characteristics, production process, foreign substances that may be introduced during the process, and the hazards introduced by the cleaning process itself. The acceptance criteria for product cleanliness after final cleaning of products should be determined, and the corresponding basis for such determination should be clarified. The product families that can use the same cleaning process should be specified, and the cleaning process verification should consider using the products most difficult to clean in the product family for verification. The evaluation of product cleanliness can consider appearance, bioburden, bacterial endotoxin, organic contamination, inorganic contamination, cytotoxicity, particulate contamination and other aspects.

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Based on the materials and structure as well as other characteristics of orthopedic implants, it is recommended the following aspects should be considered:

1. The static and dynamic mechanical properties study to be conducted for the whole product system should be determined according to the biomechanical environment where the whole product system is intended to be implanted.
2. The static and dynamic mechanical properties study to be performed between the components should be determined according to the interaction mechanism between the components in the product.
3. The static and dynamic mechanical properties study of each component should be determined according to the characteristics of each component of the product and the role it is intended to play after implantation.
4. Different assembly methods will affect the mechanical distribution and thus the stress and strain of each component, so the performance study of the whole product system cannot fully reflect the performance of the components themselves.

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