How to determine if multiple analytes for joint testing can be considered as the same registration unit
When conducting joint testing for multiple analytes, the first consideration should be whether these analytes have synergistic diagnostic significance. The joint testing products should be able to target the same applicable population and indications, taking into account the clinical application's joint testing requirements and necessity. It is not recommended to design joint testing reagents for multiple analytes that do not have synergistic diagnostic significance. Different combinations of multiple analyte test kits can be considered as the same registration unit. Different combinations are limited to cases where the detection reaction systems for each individual test are relatively independent and not mixed. For example, drug testing paper strips, five individual test paper strips, and three or four-item joint test cards. Whether it is joint testing or individual testing, the detection of each item is relatively independent and does not interfere with others. If submitted as the same registration unit, providing all technical data for all five items should cover all products. For different combinations of joint testing reagent kits, the product names can be unified based on the relevant indications, such as combining a three-item joint testing reagent with a five-item joint testing reagent as the same registration unit, named as a multi-drug joint detection reagent kit (colloidal gold method). However, individual test reagent kits cannot be unified with multi-analyte test kits due to differences in product names and usage. For example, multi-analyte test reagents using chip hybridization methods or PCR methods for each analyte in separate reactions. Cases where the reaction systems for each analyte are mixed do not fall under the above situations, such as PCR reagents where multiple analytes are mixed in one reaction system. If the product registration unit includes different combinations of multiple joint tests, registration inspection/outsourced inspection and clinical evaluation should use specifications for the most comprehensive item combinations, and product performance research data should cover all analytes being tested.
If a component in the product's structural composition is not a medical device, can this component be reflected in the product registration certificate? Is testing required for this component?
For product components that are not regulated as medical devices, they cannot be individually registered, but they can be considered as part of the medical device. If this component is declared as part of the medical device, it should be evaluated as part of the whole, and corresponding testing and verification should be conducted along with the entire device. If the applicant does not declare this component or does not test and verify it along with the whole device, it cannot be approved as part of the product. For example, printers, cables, endoscope illumination cables, neutral electrode connection cables, and similar components fall into this category.
After the approval of the clinical trial application for Class III medical devices, can we assume that the clinical trial protocol has also been approved?
The positioning of the approval for clinical trials of Class III high-risk medical devices is to decide whether to agree to conduct the clinical trial based on the application, with the aim of safeguarding the rights of participants. The focus of the review is on the preclinical research of the product, clinical benefits, and risk analysis. The design of the clinical protocol may impact the risks and benefits that the clinical trial brings to the participants, so the clinical trial protocol is one of the review contents of the clinical trial approval application. However, the clinical trial approval process does not provide final confirmation of the clinical trial protocol submitted by the applicant. Applicants can revise and improve the clinical trial protocol according to the requirements of the "Regulations for the Quality Management of Medical Device Clinical Trials," based on the communication with the review and approval personnel during the medical device clinical trial approval and registration declaration process. The technical review agency will comprehensively evaluate the safety and effectiveness of the product in the subsequent review and approval process.
Can the insulin pump body and disposable accessories be declared as the same registration unit?
The insulin pump body and disposable accessories (insulin needles, tubing) should be treated as separate registration units and declared separately.
If a product falls within various scopes of the "Catalog of Medical Devices Exempt from Clinical Trials," how should clinical evaluation data be provided during product registration?
1. With the premise of ensuring substantial equivalence to the scopes described in the "Catalog," slight adjustments can be made to the textual description of the declared product's scope. 2. For products with multiple scopes, applicants should compare the declared product's scope with the content of the "Catalog" and products already approved for domestic registration with corresponding scopes in the "Catalog." They should provide supportive data to prove that any differences do not adversely affect the product's safety and effectiveness.
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.
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.
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).
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."
How should the registration units of dental tray polymer products be divided?
Dental tray polymer materials are polymer base materials used for making denture trays and orthodontic trays. Products with different main chemical compositions should be divided into different registration units. Products that only differ in color or have added fiber components for aesthetic and performance modifications can be considered as one registration unit. Products with different polymerization mechanisms should be divided into different registration units, such as products with multiple polymerization methods for one material being considered as one registration unit. Products with different key performance indicators should be divided into different registration units. Products that must be used together inseparably to achieve the intended purpose can be considered as one registration unit.