TX Q&A

Vaseline must comply with the standards of the "Pharmacopoeia of the People's Republic of China." For imported products, reference can be made to the United States Pharmacopeia or the European Pharmacopoeia. For degreased cotton gauze or degreased cotton viscose blended gauze, it is recommended to refer to YY0331 "Performance Requirements and Test Methods for Degreased Cotton Gauze and Degreased Cotton Viscose Blended Gauze."

For products that provide decision support in triaging and referring patients based on whether they have a target disease, without specifying the exact lesion conditions, and where a professional physician must review the patient's images regardless of the triage outcome (whether negative or positive), a single-group target value design can be considered. The main evaluation metrics should focus on the diagnostic accuracy of the product's assistance in triaging, such as sensitivity and specificity, typically at the patient level. For products that assist in detecting specific lesions of a target disease, such as lung nodule detection aids or bone fracture CT image detection aids, a controlled trial design is recommended. In this setup, the experimental group consists of physicians using the product in conjunction with traditional diagnostic methods (like clinical review or comprehensive diagnosis). The main evaluation metrics should consider diagnostic accuracy indicators such as sensitivity, specificity, AFROC curves, and detection rates, with sensitivity generally assessed at the lesion level and specificity at the patient level. The type of clinical trial comparison should reflect the acceptable risk-benefit ratio of the product, and an effectiveness design is suggested. For example, for software assisting in detecting lung nodules larger than 4mm on CT images, consider superiority in specificity at the patient level and non-inferiority in sensitivity at the lesion level.

For high-frequency ultrasound integrated surgical equipment that can output high-frequency or ultrasound energy separately or simultaneously, the testing modes for electromagnetic compatibility should be considered as follows: According to the requirements in Chapter 36 of the GB 9706.4-2009 standard, "When the power is on but the high-frequency output is not excited, it should meet the limit requirements of Group 1." Therefore, for the emission test, the most unfavorable mode (which should at least include the maximum ultrasound output mode) should be selected for testing, and the test should be conducted according to Group 1 Class A. For the immunity test, the standby mode, ultrasound output mode, high-frequency output mode, and dual output mode should be selected separately, and the tests should be conducted under the most unfavorable conditions.

According to Article 3 of the "Guidance Principles for the Division of Medical Device Registration Units," products should be classified into different registration units if differences in their structural composition or processing methods lead to different performance indicators. For facial injectable fillers, they should be classified into different registration units if there are differences in chemical composition, ratio (concentration), cross-linking method, degree of cross-linking, gel particle size distribution, designed average molecular weight, and its distribution. However, for the same product intended for different parts of the face, such as for altering the contours of the mid-face or for rhinoplasty, it can be classified into the same registration unit.

In order to evaluate the analytical performance of in vitro diagnostic reagents, it is usually required to select samples from the applicable population at different times, different locations, and with different representativeness (such as age, gender, ethnicity, and other situations) to assess the detection capability, that is, to select samples from "different sources" for evaluation. The selection of representative samples should be determined based on factors such as the characteristics of the product itself and its intended clinical use.

If a new model of a high-voltage generator is added and the overall performance is substantially equivalent, it can, in principle, be declared as the same registration unit. This approach can also be applied to the addition of new models of X-ray combination heads for dental cone beam CT devices.

According to the requirements for dividing registration units, products with significant differences in technical principles, structural composition, performance indicators, and scope of application should be classified into different registration units. Following these principles: 1. High-speed air turbines and dental contra-angle handpieces/dental straight handpieces should be classified into different registration units. 2. Within dental contra-angle handpieces/dental straight handpieces, devices that hold root canal files for enlarging tooth root canals, devices used for oral implant treatments, and devices used for drilling and grinding teeth should each be classified into different registration units. 3. Handpieces with lighting devices and those without should be classified into different registration units; however, those with light guides and those without lighting can be placed in the same registration unit.

According to the "Regulations on the Registration and Filing Management of Medical Devices" and the "Regulations on the Registration and Filing Management of In Vitro Diagnostic Reagents," the medical device product inspection report submitted for registration or filing can be a self-inspection report by the applicant or filer, or an inspection report issued by a qualified medical device inspection institution. The inspection can be categorized into three types: full self-inspection, partial self-inspection combined with partial commissioned inspection, and full commissioned inspection. For full self-inspection and partial self-inspection combined with partial commissioned inspection, the inspection should be conducted according to the "Regulations on Self-Inspection Management of Medical Device Registration." When applying for registration or filing, the submission should comply with the "Documentation Requirements" section of the "Regulations on Self-Inspection Management of Medical Device Registration." For full commissioned inspections, the inspection process should refer to the "Commissioned Inspection Requirements" section of the "Regulations on Self-Inspection Management of Medical Device Registration." When applying for registration or filing, the following documents must be submitted: 1. An inspection report issued by a qualified medical device inspection institution; 2. If a foreign registration applicant delegates the inspection to a Chinese agent, the power of attorney in China should clearly state that the agent is "authorized to commission a qualified medical device inspection institution in China to inspect the product intended for registration based on the product's technical requirements," and the agent's commitment letter should include corresponding content; 3. All the above documents must be signed by the registration applicant or agent, and the format of the documents should meet the requirements of Annex 4 of the "Announcement on the Requirements for Medical Device Registration Application Documents and Format of Approval Certificates" (No. 121 of 2021) and Annex 3 of the "Announcement on the Requirements for Registration Application Documents and Format of Approval Certificates for In Vitro Diagnostic Reagents" (No. 122 of 2021).

Test reports in research materials serve as a form of evidence for design verification. There are no specific regulatory requirements regarding the qualifications or the issuing bodies for these test reports. Therefore, there are no mandatory qualifications required for testing institutions conducting tests like fatigue and other dynamic tests, virology tests, and immunology tests.

Bland-Altman analysis is commonly used to evaluate the consistency of paired quantitative detection results. In the Bland-Altman analysis of quantitative detection results for in vitro diagnostic reagents, it is important not only to calculate the limits of agreement based on the deviation of the test results but also to set appropriate acceptable standards based on clinical requirements. The evaluation should determine whether the limits of agreement fall within the acceptable standards. The setting of clinically acceptable standards should have a reasonable basis.