Do manufacturing companies need to use clinical samples for reference materials?
Enterprise reference materials are an important tool for product design, development, and quality control. It is recommended that when preparing enterprise reference materials, clinical samples should be used as a priority. For very rare samples, alternative samples such as pathogen cultures or cell lines may be considered. The specific choice should comply with the guidelines relevant to the product in question.
What are the storage condition requirements for the stability study of in vitro diagnostic reagents?
The stability of in vitro diagnostic reagents refers to the ability to maintain their performance characteristics within the limits specified by the manufacturer. When conducting stability studies for reagents, it is important to consider variables that might affect the performance or efficacy of the reagents, including changes in environmental factors and the worst-case scenario. During the study, reagents should be stored under conditions specified by the manufacturer, which are set based on the capabilities of the testing equipment or the expected storage conditions of the product. These conditions should adequately validate the product's stability under the most adverse conditions. The results of the study should demonstrate that the product meets the stability requirements within the claimed storage conditions and duration. It is recommended that applicants clearly specify the range of storage conditions in their research documentation and stability claims, such as "store at 2~8°C," and avoid using ambiguous terms like "refrigerated," "frozen," or "room temperature" to describe storage temperatures.
Is it necessary to conduct biological tests if the primary packaging of infusion products changes?
Changes in primary packaging require revalidation of sterilization and expiration dating, but generally, biological testing is not necessary.
How to conduct clinical evaluation of all-suture anchors through comparison with similar products
All-suture anchors can be clinically evaluated by comparing them with similar types of devices that have already been approved for market in the same region and have the same scope of application. The comparison with similar medical devices should include design principles, structural composition, size specifications, operational performance, and mechanical properties. The comparison of structural dimensions should include both the dimensions in the natural state and after the soft anchor contracts, identifying differences such as the weaving method and the thickness of the individual strands. For any differences in structural dimensions, it is necessary to explain why this design was chosen for the product being registered and to demonstrate that these differences do not adversely affect the product's safety and effectiveness. Operational performance comparisons should include insertion force and whether the soft anchor is prone to knotting. For non-quantitative operational performance indicators, if product design validation data demonstrate that it meets clinical needs, there may be no need to compare with similar products. Mechanical performance comparisons should include both dynamic and static fixation performance, and the mechanical performance of the product being registered should not be inferior to that of similar products. When comparing mechanical performance with similar devices, attention should be paid to the appropriateness of test parameters (such as load size and cycle count) and the selection of mechanical test fixtures. If using artificial bone, it is recommended to determine the composition, thickness, and density of the simulation blocks (such as cortical/trabecular bone composite blocks) based on the bone quality conditions in clinical use, and ensure that the test drilling diameter is consistent with the diameter used clinically. When providing mechanical test reports, it is important to clearly define the failure modes of each sample. For anchors expected to be used in anatomical sites with significantly different biomechanical requirements, comparisons should be made separately with anchors that have the same range of applicability.
Should performance specifications be considered for outsourced syringe components in sodium hyaluronate products for injection?
Outsourced syringe components used in sodium hyaluronate products for injection, as part of the product, should have relevant performance specifications established and tested.
Do fiber posts made from fiber fillers and resin composites need to have a product shelf life?
Fiber posts, made from fiber fillers and resin composites, are devices implanted into root canals and carry a high risk. Their performance is greatly affected by environmental temperature, so it is recommended to establish a shelf life and provide relevant shelf life study data.
Is it necessary to include "stability" as a performance indicator in the technical requirements for in vitro diagnostic reagent products?
According to the "Guidelines for the Preparation of Technical Requirements for Medical Devices" (National Medical Products Administration Notice No. 8 of 2022) under "Section IV: Performance Indicator Requirements," the "shelf life of medical devices" is considered "research and evaluative content that is not recommended to be specified in the performance indicators of technical requirements." This recommendation also applies to the technical requirements for in vitro diagnostic reagents, meaning "stability" does not need to be included as a performance indicator in the technical requirements for these products.
What should be considered when establishing peak tensile strength testing methods for intravascular catheters and guidewire devices in product technical requirements?
1. The testing method for the peak tensile strength of intravascular catheters should comply with YY0285.1-2017. However, due to different segmented structures of various products, the segments that need to be tested vary. To further clarify whether the tested body and connections meet the standard requirements, applicants should refine the testing methods based on the specific structure of the product, such as specifying the exact locations of each test segment and their minimum outer diameter. 2. For intravascular guidewire devices, the testing methods should be based on the YY0450.1-2020 standard, taking into account the requirements mentioned above. 3. It is recommended that components used in the delivery systems for intravascular devices also refer to the above requirements.
Do passive vascular implantable medical devices with a delivery system or accessories require separate biological evaluations for the implant components and the delivery system or accessories?
For passive vascular implantable medical devices that include a delivery system or accessories, such as stents and occluders preloaded onto a delivery system, it is advisable to conduct separate biological evaluations for the components intended to remain in the body long-term and for the delivery system or accessories during the registration process. This is because there is a significant difference in the nature and/or duration of contact with the body between the parts expected to be permanently implanted and their delivery systems or accessories.
How to choose the clinical evaluation pathway for dental implants
Dental implants are generally made of titanium or titanium alloys and are implanted into the upper and lower jawbones of edentulous areas through surgical procedures to provide fixation or support for restorations such as dentures, thereby restoring the patient's chewing function. To clarify the clinical evaluation requirements for implants of the same type, unify evaluation standards, and combine the current development status of the dental implant (system) industry and current technical review requirements, targeted proposals and standards for the clinical evaluation of such products were developed after researching the product review requirements in the United States, Japan, and the European Union. The Medical Device Technical Review Center organized the drafting of the "Guidelines for Clinical Evaluation Registration Review of Dental Implant Systems of the Same Type," and a draft for comments was released on November 23, 2021. The draft summarizes the current technical review requirements for the clinical evaluation of dental implants, clearly stating that applicants can conduct clinical evaluations of dental implant systems by comparing them with one or more medical devices of the same type. The comparison focuses on, but is not limited to, the product's scope of application, structural composition, raw materials, mechanical properties, surface treatment, etc. (mechanical properties, etc., can include measured data comparison of the declared product with the same type of product), proving their fundamental equivalence. Then, data obtained from clinical trials or clinical use of the same type of products (such as clinical literature data, clinical experience data, etc.) can be analyzed and evaluated to prove the safety and effectiveness of the declared product. Regarding differences between the declared product and products of the same type, supporting materials can be submitted showing that these differences do not adversely affect the safety and effectiveness of the declared product. For example, if there is a significant difference in surface modification between the declared product and products of the same type, animal experiments can be conducted to observe whether the surface modification adversely affects the bone integration and initial stability of the implant. Combining the intended clinical use of the declared product, the level of similar products on the market, clinical data of the declared product (if any), and clinical treatment requirements, a comprehensive analysis of the clinical acceptability of the declared product is performed to demonstrate its safety and effectiveness. Currently, several domestic dental implant companies have submitted clinical evaluation materials through the same type comparison clinical evaluation pathway and have obtained registration certificates.