How should the applicant of infusion products verify the claimed special performance of the products?
In addition to establishing corresponding physical and chemical requirements based on the product characteristics in the technical requirements, the applicant should simulate the actual clinical use conditions to verify the special performance of the product. The verification tests should consider aspects such as product design, intended use, methods of use, and duration of use, and suitable test methods should be developed based on the product characteristics. When developing the test plan, the following should be considered at least: 1) The test steps should be consistent with actual clinical operations; 2) The selection of test conditions should cover possible clinical scenarios; 3) The sample size for testing should reflect scientific rigor; 4) The number of verifications should not be less than the claimed number of uses of the product; 5) Other relevant guidance documents, etc.
How should the shelf life of dialysis concentrate products be determined? How should stability verification studies be conducted for dialysis concentrate products?
The stability verification of concentrates is recommended to reference the "Guiding Principles for Stability Testing of Raw Materials and Preparations" in the Chinese Pharmacopoeia. Submit verification data for long-term testing of drug formulations and determine the product's shelf life based on the results. Observe the stability of concentrates for all models and package sizes at different assessment time points under the selected storage conditions of temperature and humidity corresponding to southern or northern regions during actual storage and transportation. Observation parameters should include clauses in the technical requirements and analysis of chemical contaminants. As per the technical requirements, provide inspection results for solute concentration, insoluble particles, microbial limits (or sterility), endotoxins, etc., at different assessment time points for concentrates. For dry powder, include comparative results for dissolution time. For online use of B-type dry powder products, provide test results for ion concentration and pH values of at least four time points (at the start of dialysis, at three equal intervals during clinical use, and at the end of dialysis). Chemical contaminant analysis at different assessment time points should refer to the detection indicators in YY 0572 "Water for Hemodialysis and Related Therapies," and chemical ions already present in the raw materials of the formulation do not need to be tested.
Can the radiotherapy planning system be declared as the same registration unit as the radiotherapy equipment?
If the radiotherapy planning system is a general planning system that can be used with multiple radiotherapy devices, it should be declared separately. However, if it is a dedicated planning system for a specific radiotherapy device, it can be declared together with that radiotherapy equipment.
Do all changes to the instructions for in vitro diagnostic reagents require application for permission to change?
Changes to the content of the instructions for in vitro diagnostic reagent products fall into two categories: textual changes to informational content and other content changes. 1. Textual Changes to Informational Content: According to the "Notice on Textual Changes to Instructions for In Vitro Diagnostic Reagents" (SFDA Medical Device Office [2016] No. 117), applicants can make textual changes to informational content on their own. Specifically, changes may include: - Changes in basic information such as contact details of the registrant or manufacturer of in vitro diagnostic reagents, the name and contact details of the after-sales service unit, changes in the production license number or production filing certificate number, and changes in the contact details of the agent for imported in vitro diagnostic reagents. Changes to the production license number or production filing certificate number should be made after the corresponding provincial food and drug supervision department has issued the production license or production filing certificate. - Changes in the Medical Device Registration Certificate number/Product Technical Requirements number should be made by the registrant after the corresponding food and drug supervision department has issued the medical device registration certificate. - Changes in the interpretation of labels should be made by the registrant if it enhances the explanation of corresponding labels in the instructions according to the YY/T 0466 series standards, without involving other changes that require permission. 2. Other Content Changes: The content of the instructions for in vitro diagnostic reagents should be considered as part of the registration certificate. Apart from the aforementioned informational content changes, other content changes should be modified through an application for permission to change. Notification of changes to the instructions does not apply to in vitro diagnostic reagents.
Does the injectable sodium hyaluronate gel for plastic surgery require an in vitro degradation test, and what are the specific requirements?
Referring to YY/T 0962-2014 "Cross-linked Sodium Hyaluronate Gel for Plastic Surgery," for injectable sodium hyaluronate gel used in plastic surgery, it is recommended to establish requirements for in vitro degradation testing in the product technical requirements. This serves as a quality control measure for the degradation performance of sodium hyaluronate gel. It is suggested to set multiple observation time points, observe until the complete degradation of the sodium hyaluronate gel, and specify upper and lower limit requirements for the degree of degradation at different time points. In vitro testing can accelerate degradation by adjusting experimental conditions such as the concentration of degrading enzymes.
The factors to consider besides regulatory requirements when choosing a clinical trial institution for in vitro diagnostic reagents
When selecting a clinical trial institution for in vitro diagnostic reagents, in addition to regulatory qualifications, attention should also be paid to whether the institution has the conditions and capabilities to conduct clinical trials. Firstly, the institution should have the capability to conduct the relevant testing projects, be familiar with the testing projects for the products to be evaluated, and routinely carry out the corresponding tests. If it involves new products or markers, institutions should also choose those familiar with the relevant methods or similar tests and regularly conduct related disease diagnosis and treatment work to conduct the trials. Evaluation of the institution's testing capabilities should include laboratory conditions and personnel. Secondly, the selected institution should be able to recruit a sufficient number of eligible participants for the trial and choose institutions with specific disciplinary advantages for the product's specific indications. Additionally, the clinical trial institution should be able to ensure cooperation in the registration declaration process, including conducting necessary supplementary tests, and assisting with clinical trial audit.
If the shelf life of the product is shortened, is it unnecessary to submit technical documents again in the application for permit changes?
Although the risk of quality changes during the storage period decreases when the shelf life of the product is shortened, it is advisable for the registrant to provide a reasonable explanation and necessary supportive materials when applying for permit changes. For instance, if it is discovered after conducting real-time stability testing that the shelf life of the product should be shortened, it is recommended to provide verification data from this real-time stability testing.
Accelerated stability tests for the final product were conducted at 60°C. Can we avoid specifying the storage conditions for the product?
Accelerated stability testing involves subjecting a product to external stress to assess material degradation under stress conditions. By using known acceleration factors and degradation rates, the test infers the material degradation under normal storage conditions. Therefore, storage conditions are directly related to shelf life, and it is necessary to specify the product's storage conditions.
What is a software core algorithm? Can it be considered a non-core algorithm if there are no post-processing algorithms for medical images and data?
A core algorithm refers to the algorithms necessary to implement the core functions of software (functions necessary for the software to achieve its intended purpose in the expected usage environment), including but not limited to imaging algorithms, post-processing algorithms, and artificial intelligence algorithms.
When applying for permit changes to add models for active products, is testing mandatory? Can the testing report of the original model cover this?
First, it should be confirmed whether the additional model applied for can be considered as the same registration unit as the original model. If they can be considered as the same registration unit, you can apply for permit changes to add models. In cases not involving new standards, the determination should follow the principle of typical model representation. If the original model can represent the new model, there is no need to repeat the testing. If new standards are involved, a testing report for the new model against the new standards should be provided. If some items in the testing report of the original model can represent the testing of the new model, there is no need to repeat testing for those specific items.