TX Q&A

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.

The insulin pump body and disposable accessories (insulin needles, tubing) should be treated as separate registration units and declared separately.

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.

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.

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.

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."

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).

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.

Biological evaluation should consider factors such as the materials used in manufacturing the product, expected additives, process impurities and residues, leachables, degradation products, physical characteristics of the final product, interactions between components and their presence in the final product, packaging materials, and the impact of storage media on biocompatibility. Therefore, biocompatibility testing of the product should ideally be conducted using the final product or representative samples taken from the final product. If testing with the final product is not feasible, samples produced using the same manufacturing process as the final product can be considered for testing, but the representativeness of the samples should be thoroughly analyzed and demonstrated. Additionally, when a device has different component materials, consideration should be given to possible chemical reactions between the different components and their combined effects on the human body when selecting test samples. However, if different components of a medical device have varying levels of contact with the body and different contact durations, biological testing should be conducted separately.

1. If the newly added functional parameters are equivalent to products listed in the "Exempt from Clinical Trial Catalog," they can be evaluated according to relevant clinical evaluation requirements. 2. If the patient monitor with the new functional parameters belongs to the same category of medical devices, it can be evaluated through clinical assessment. If overseas data for the new functional parameters comply with the "Guiding Principles for Accepting Overseas Clinical Trial Data for Medical Devices," relevant clinical data can be provided. 3. If the patient monitor with new functional parameters cannot be clinically evaluated through the above methods, consideration should be given to conducting clinical trials to confirm the product's scope of use.