TX Q&A

Ordinary ultrasonic blades (excluding the transducer) only conduct sound energy, not electrical energy, and theoretically do not affect electromagnetic compatibility. Some ultrasonic blades have chips inside for functions such as identifying single-use and collecting blade working parameters, which require power and may affect electromagnetic compatibility. For ultrasonic blades that do not have chips and do not conduct electrical signals or energy, one model of blade can be chosen for testing.

Some liquid products used for assisted reproduction have already been included in the "Catalogue of Medical Devices Exempt from Clinical Trials." For those not included in the catalogue, it is recommended to select an appropriate clinical evaluation pathway based on the actual characteristics of the product being registered and the supporting data available. This includes clinical trials and the same kind clinical evaluation pathway. If a company plans to register through the same kind clinical evaluation pathway, consider the following for a comprehensive evaluation: 1. Given the diverse components of liquid products used for assisted reproduction, if the selected single same-kind product's components do not cover all components of the product being registered, consider adding more same-kind devices to support the components not covered by the single same-kind product. 2. For common basic components like saline, energy substrates, acid-base buffering systems, amino acids, human serum albumin, antibiotics, etc., if it is not possible to obtain the concentration of each component of the same kind, and if the concentration differences do not affect safety and effectiveness as demonstrated by performance indicators such as pH, osmolarity, impurity limits, usability performance indicators, and mouse embryo assays, concentration comparison information need not be provided. Concentration comparison information must be provided for special functional components related to the intended use, and the impact of any differences on safety and effectiveness should be evaluated. 3. When conducting a same kind clinical evaluation, use clinical literature data and clinical experience data, ensuring that the evaluation indicators reflect the clinical use of the product and relevant clinical outcomes, including applicable indicators such as fertilization rates, cleavage rates, blastocyst rates, implantation rates, and pregnancy rates.

The technical review of medical device clinical evaluations is conducted based on the clinical evaluation data submitted by the company. If, after the applicant submits the registration materials, the product is included in the officially published "Catalogue of Medical Devices Exempt from Clinical Trials," the applicant can complete the clinical evaluation via the pathway outlined in the Catalogue when providing supplemental data. In such cases, considering that the clinical evaluation data in the supplemental materials may significantly differ from what was originally submitted, the applicant should fully utilize post-submission consultations and pre-review communication channels to engage thoroughly with the reviewers.

Referring to the PET/CT guidelines, if the number of detector rings in the PET component differs, it is recommended to classify them as separate registration units.

The Limit of Detection (LoD) is a crucial performance indicator for in vitro diagnostic reagents. Typically, LoD studies are conducted using reagents from three different batches. If the LoD results from these batches differ (there generally should not be significant differences), the highest value or an even higher value should be taken as the claimed LoD for the reagent. This ensures that all batches of the reagent meet the claimed standard.

(1) The applicant needs to confirm that the tested similar product in the test report is completely consistent with the product being registered in terms of material chemical composition, proportion of each component material, product physical structure, surface characteristics, production process, sterilization method, raw material suppliers and technical specifications, internal packaging materials (if applicable, mainly involving liquid products and products preserved in a wet state), and any other factors that may affect the biocompatibility risk, and provide a relevant declaration. (2) If there are inconsistencies between the test sample and the product being registered in the above-mentioned factors that may affect the biocompatibility risk, sufficient reasons and evidence need to be provided to support that the submitted test report is applicable to the product being registered. When necessary, supplementary biological evaluation materials should be provided, such as leachable analysis and toxicological risk assessment materials, supplementary tests for relevant biological test items, etc. (3) The biological test report of a similar product is only used to replace the test report of the product being registered as part of the biological evaluation, and not to replace the overall biological evaluation report of the product being registered.

At this point, it should be analyzed whether the change involves the product's technical requirements and other contents specified in the registration certificate. If it does, an application for a change in the registration of the licensed items should be filed.

Feasibility trials can preliminarily assess the safety and performance of a product, providing information for the design of confirmatory trials. The purpose of feasibility trials differs from that of confirmatory clinical trials. The statistical analysis of trial results should follow a pre-specified statistical analysis plan; it is not recommended to combine the results of feasibility trials and confirmatory clinical trials for statistical analysis after the trials have concluded.

Joint-related products, whether declared as a system or as components (such as product registration, or changes in licensing matters), require research on the overall performance of the declared product (when declared as a system) and the performance of components within the system, or the declared product (when declared as components) and the performance related to its adjacent components. Relevant research materials must be submitted to demonstrate the safety and effectiveness of the product.

1) For contrast catheter products injected using a high-pressure injection device, the maximum burst pressure information must be marked in the technical requirements and instructions (label), and the requirements for power injection should be specified in accordance with YY0285.1-2017. 2) For contrast catheter products injected using a loop handle syringe, there is no need to establish power injection requirements. The following warning should be clearly stated in the instructions: Do not use a high-pressure injection device to inject contrast agents. For other catheters that include vascular imaging functionality, refer to the above requirements.