How to choose a clinical evaluation pathway for medical devices
The "Regulations on the Supervision and Management of Medical Devices" stipulate that clinical evaluations of medical devices can be conducted based on product characteristics, clinical risks, and existing clinical data. These evaluations can be carried out either through clinical trials or by analyzing and evaluating clinical literature and data of similar medical devices to demonstrate their safety and effectiveness. Applicants for registration may refer to the "Technical Guidance on Deciding Whether to Conduct Clinical Trials for Medical Devices" to determine the necessity of conducting clinical trials. Additionally, they should consider the recommended clinical evaluation pathways for products related to the sub-categories in the "Medical Device Classification Catalog" recently released by our center, to choose the appropriate clinical evaluation pathway.
What documentation is required for the application to change the packaging specifications of in vitro diagnostic reagents?
When there is a change in the packaging specifications of in vitro diagnostic reagents, it is necessary to describe in detail the differences in packaging specifications before and after the change. Based on these differences, identify all relevant potential risks and analyze and verify these risk factors. For example, if there are differences in the form of reaction (such as drug detection products) or the size of the reaction strips (such as PCR amplification hybridization products) before and after the change, analytical performance evaluation data of the new packaging specifications should be submitted. If there is a significant change in the packaging capacity or container, leading to increased risks of evaporation or loss, consider whether there are changes in the product's shelf life, usage stability, and calibration frequency.
Should companies evaluate the impact of variants on COVID-19 nucleic acid test kits?
To meet the needs of epidemic prevention and control, companies should continuously monitor virus mutations for all COVID-19 nucleic acid test kits, whether before or after they are marketed. Companies must actively assess the kits' ability to detect virus variants. If the product is in the pre-market stage, evaluation results should be submitted along with the registration materials. If the product is already on the market, companies need to cooperate with the working group assessing the detection capability of coronavirus variants and regularly submit evaluation data.
Can the results of qualitative reagent interference tests be represented solely by positive or negative outcomes?
Interference tests are generally conducted using a paired comparison method, comparing the differences in results between samples containing high concentrations of interfering substances and those containing none or normal concentrations (control). For qualitative reagents that do not provide quantitative data, results of interference tests can be represented simply as positive or negative. However, it is important to include samples at weakly positive levels in the study. For qualitative reagents that make threshold judgments based on quantitative data (such as OD values, Ct values, or count results), it is recommended to perform a differential analysis of the quantitative data, rather than solely using positive or negative to represent the results of the interference tests.
What is the detection system for in vitro diagnostic reagents?
The detection system for in vitro diagnostic reagents refers to a combination that includes products for sample processing, test reagents, calibrators, quality controls, and testing equipment, capable of completing all stages from sample processing to the final result report. The entire detection system undergoes a thorough safety and efficacy evaluation and is approved for use. During the product registration process for in vitro diagnostic reagents, it is possible that not all other products needed to complete the testing are included. In such cases, it is necessary to clearly specify the accompanying products in the instructions manual to ensure that the testing is conducted according to the detection system composed of all supporting products. For example, for nucleic acid test reagents that do not include extraction reagents, the extraction reagents specified in the manual must be used during performance evaluation and clinical evaluation.
What adjustments have been made to the management category of tumor marker-related reagents?
In October 2020, the National Medical Products Administration issued an announcement (2020 No. 112) regarding adjustments to some contents of the "6840 Sub-catalog of In Vitro Diagnostic Reagents Classification (2013 Edition)." The management category for some tumor marker-related reagents used for therapeutic monitoring has been adjusted to Class II. The tumor marker-related reagents used for auxiliary diagnostic purposes in the "6840 Sub-catalog of In Vitro Diagnostic Reagents Classification (2013 Edition)" have not undergone category adjustments and continue to be managed as Class III.
How should the biological evaluation of blood purification products for patients with renal failure be considered?
According to the current GB/T 16886 "Biological Evaluation of Medical Devices" series of standards, the overall biological evaluation should consider the following aspects: (1) materials used in manufacturing; (2) expected additives, process contaminants, and residuals; (3) leachable substances; (4) degradation products (if applicable); (5) other components and their interactions in the final product; (6) performance and characteristics of the final product; (7) physical properties of the final product, including but not limited to porosity, particle size, texture, and surface morphology. Based on the clinical intended use of the product, the biological evaluation should consider the cumulative duration of use, in accordance with the requirements for prolonged contact between the external device and circulating blood. If the product uses new materials, or may contain carcinogenic, mutagenic, and/or reproductive toxic substances, it is also recommended to consider related endpoints in the risk assessment.
What Items Need to Be Verified for the Compatibility of Needle Heads with Disposable Injection Pens?
Applicants for registration must provide verification data related to the functional compatibility of the product with the injection pen. Generally, this includes verification of needle hub assembly, dose accuracy, and needle hub disassembly torque. The needle head is connected to the injection pen by applying a specified torque, and the integrity of the clinically relevant fluid pathway is confirmed through dose accuracy testing. The disassembly torque of the needle hub is also measured and recorded. Additionally, a rationale should be provided for the number of products verified, clarifying parameters such as confidence levels and reliability.
Does polyurethane foam dressing with adhesive backing fall under the category of "Polyurethane Foam Dressing" in the Catalog of Class III Medical Devices Exempt from Clinical Evaluation?
Polyurethane foam dressings with adhesive backing are included in the "Catalog of Medical Devices Exempt from Clinical Evaluation." However, it is important to note that the exemption from clinical evaluation does not apply to the following situations: 1) Products claimed to promote epithelialization, guide tissue regeneration, enhance wound healing, relieve pain, stop bleeding, reduce scarring, prevent adhesion, etc.; 2) Products claimed to be used for internal wounds, third-degree burns, infected wounds, wounds with extensive necrotic tissue, patients with wound sepsis, etc.; 3) Products containing active ingredients such as drugs/pharmaceutical active ingredients, biological products/biological active components, silver, disinfectants, etc.; 4) Other novel products.
How to Assess the Risks of Medical Devices Using Nanomaterials
Risk assessment for medical devices that utilize nanomaterials should be conducted according to GB/T 16886.1 "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process," YY/T 0316 "Application of Risk Management to Medical Devices," and "Medical Device Product Benefit-Risk Assessment Registration Technical Review Guidelines." It is crucial to consider risk factors such as the potential for nanomaterials to be released from the device, exposure dose, routes of exposure, contact sites, and exposure duration. The most critical factor in the risk assessment is the likelihood of nanomaterial release from the medical device. The risk assessment should be conducted in stages and systematically, taking into account exposure assessment (release of nanomaterials), distribution and persistence of nanomaterials, environmental transformation, and hazard identification. Finally, the overall risk of the product should be considered in light of the scope of its use and whether it provides sufficient benefits to the patients.