Should stability verification be conducted for all models and fill volumes of dialysis concentrates?
For all models and fill volumes, real-time stability verification data should be submitted. The assessment should consider the impact of actual storage and transportation conditions, temperature, humidity, time, etc. It should include requirements specified in the technical specifications and take into account the product's characteristics. Reference can be made to relevant requirements in the "Chinese Pharmacopoeia" and the guidelines for stability testing of active pharmaceutical ingredients and drug formulations, as well as the testing index items in YY 0572 "Water for Hemodialysis and Related Therapies."
When declaring active products such as monitors, if Company A's main unit is used together with Company B's consumables, can the main unit and consumables be declared under Company A's name?
1. If the consumables act on the human body invasively, it is recommended to register them separately. 2. If Company B's consumables have obtained a registration certificate and are indicated as compatible with Company A's main unit in the certificate or are generic accessories, they do not need to be declared together with Company A's main unit. 3. If Company B's consumables have not obtained a registration certificate and do not act invasively on the human body, they can be declared under Company A's name along with the main unit. Company A should list all information about the consumables used in conjunction with the main unit in the accompanying documents, including brand, name, model, specifications, and medical device registration number (if applicable).
After the release and updates of national reference standards, issues related to the implementation of reagent testing in different registration stages
According to Article 25 of the "Regulations on the Registration and Management of In Vitro Diagnostic Reagents" (Decree No. 5), products with national standard substances and reference materials should undergo registration testing using these national standards and reference materials. Annex 4 of the "Announcement of the State Food and Drug Administration on the Requirements for Submission of Registration Data and Approval Document Format for In Vitro Diagnostic Reagent Registration" (No. 44 of 2014) requires: "If there are national standard substances or reference materials released or updated, inspection reports demonstrating that the products meet the requirements of these national standard substances and reference materials should be provided. These inspection reports can be self-inspection reports, commissioned inspection reports, or inspection reports that comply with the relevant notification requirements." Based on the above requirements, when applying for registration or renewal of in vitro diagnostic reagent products, if applicable national standard substances or reference materials have been released or updated (based on the publicly available instructions of the national standard substances and reference materials to assess their suitability for the product), they should comply with the requirements of the national reference materials. For product registration applications, if the national standard substances or reference materials have been released or updated before the date of sample collection for inspection, registration testing should be conducted using these national standards and reference materials or through commissioned inspection and meeting their requirements. For renewal applications, if the national standard substances or reference materials have been released or updated before the date of acceptance of the renewal application, self-inspection or commissioned inspection should be conducted using these national standards and reference materials and meeting their requirements. If the product has already obtained a medical device registration certificate, changes to the conformity requirements of the new national standard substances or reference materials can also be made through an application for permit changes, by revising the technical requirements of the product to comply with the newly released national standard substances or reference materials and submitting self-inspection reports or commissioned inspection reports demonstrating compliance.
How should the registration units of dental burs be divided?
Dental burs are a type of dental rotary instrument consisting of a handle and a working end head used to cut dental tissue to remove diseased tissue, treat cavities, or prepare teeth. Products made of different materials should be classified into different registration units, such as tungsten steel burs and diamond burs being separate registration units. Products manufactured using different production processes should be divided into different registration units, such as burs processed through mechanical machining, powder metallurgy, or chemical vapor deposition (CVD) techniques should be considered separate registration units. Products with different levels of coarseness of abrasives can be considered under the same registration unit.
Do consumables for assisted reproductive technology (excluding liquids for assisted reproductive technology) need to undergo mouse embryo testing after biological evaluation according to GB16886.1?
Consumables for assisted reproductive technology (excluding liquids for assisted reproductive technology) target gametes, zygotes, and embryos at different developmental stages. In addition to routine biological evaluation, in vitro mouse embryo testing should also be conducted in accordance with YY/T1434-2016.
When registering in China, are biocompatibility test reports issued by foreign labs recognized?
Biological test reports from foreign labs must be accompanied by quality assurance documents from the lab indicating compliance with GLP lab requirements. If they meet relevant technical requirements (such as GB/T 16886/ISO 10993 series standards), they can be submitted as biological test data to support medical device biological evaluations.
How should the registration units for rib plates be divided?
Rib plates are used for internal fixation of rib fractures or deformity correction. Rib plates and limb fixation plates are classified as different registration units. If the materials used in the products are different (including material grades), they should be categorized into separate registration units. Based on the commonly used metal materials for rib plates, they can be divided into registration units such as TA3 pure titanium, Ti6Al7Nb titanium alloy, nickel-titanium alloy, etc.
Determining the shelf life of in vitro diagnostic reagents
The shelf life of in vitro diagnostic reagent products should be determined based on real-time stability study data. Real-time stability study experiments should be completed before registration application, and the product's shelf life should be determined based on the test results. Real-time stability studies should include data from at least three batches of samples stored under actual storage conditions until the end of the product's shelf life. At the same time, adverse conditions during storage, transportation, and use of the product should be thoroughly considered, and corresponding stability studies should be conducted. If real-time stability studies are ongoing at the time of registration application, the shelf life can be determined based on completed experiments during the application, and after completing the relevant stability studies later, the shelf life can be extended through a change application.
Can high-frequency electrodes with coated tips be classified in the same registration unit as those without coating?
According to the "Guiding Principles for the Division of Medical Device Registration Units" (Notice No. 187 of 2017) and with reference to the principles of registration unit division in the "Guiding Principles for the Registration Review of Surgical Electrodes" (Revised in 2017), high-frequency electrodes with coated tips can be considered the same registration unit as those without coating.
Can calibration and quality control materials be added to the reagent registration unit through a change application?
If an applicant wishes to add calibration and/or quality control materials to an in vitro diagnostic reagent registration unit that originally did not include them, they can apply for this through a change in licensing under the following conditions: they must provide evidence demonstrating that the added calibration and/or quality control materials were indeed intended for use with the reagent at the time of registration, these added materials match the original product's reaction system and testing processes, adding calibration and/or quality control materials does not alter the product's traceability and quality control methods, and the quality system at the time of registration should cover the intended additional calibration and quality control materials. Supporting evidence may include, but is not limited to: proof of using the intended calibration and quality control materials during product registration testing, evidence of quality system coverage, and documentation from the original registration that supports the above points. Otherwise, calibration and/or quality control materials cannot be added to the original registration unit through a change in licensing.