Can a new model of a high-voltage generator for a registered CT device be declared as the same registration unit?
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.
What are the requirements for the medical device product inspection report submitted for registration or filing?
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).
Do test reports in research materials, such as fatigue and other dynamic tests, virology tests, and immunology tests, have to be issued by a qualified testing institution?
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.
Precautions for Bland-Altman Analysis of Quantitative Detection Results in In Vitro Diagnostic Reagents
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.
Understanding the Circumstances Under Which Infusion Products Are Not Exempt from Clinical Evaluation in the Exemption Catalog
The catalog specifies that exemptions do not include products with new materials, new mechanisms of action, or new functions. Here, "new" refers to materials, mechanisms of action, and functions that have not been used in similar infusion devices already marketed domestically. Regarding new materials: For instance, if the TOTM plasticizer used in PVC materials for infusion tubing has already been used in similar marketed products, an infusion device made with PVC materials containing TOTM plasticizer is not considered to use new materials and can be exempt from clinical evaluation. Regarding new mechanisms of action: If an infusion device uses a float-type or membrane-type stop fluid component, and the same component has been used in similar marketed products, this mechanism of action is not considered new. Thus, the product can be exempt from clinical evaluation during the registration process. Regarding new functions: For example, if an infusion needle offers anti-needlestick functionality, and this function has already been used in similar marketed products, it is not considered a new function. Therefore, the product can be exempt from clinical evaluation during the registration process.
What information should be included in the "Product Performance Indicators" section of the instructions for in vitro diagnostic reagents?
The "Product Performance Indicators" section of the instructions for in vitro diagnostic reagents should include all the analytical performance assessments and clinical trial results of the product. For in vitro diagnostic reagents exempt from clinical trials, the results of their clinical evaluations must be stated.
What to Consider When Using Reversed Typing Red Blood Cell Reagents with Microcolumn Gel Cards
When conducting clinical trial registrations and applications for reversed typing red blood cell reagents and microcolumn gel card products, it is essential to consider the compatibility of the products. It is also important to ensure that both the in vitro diagnostic reagents and the comparative methods used in the clinical trials are performed with the corresponding reversed typing red blood cell reagents and microcolumn gel cards. Generally, the instructions for reversed typing red blood cells do not specify the microcolumn gel cards to be used in conjunction. However, the instructions for the microcolumn gel cards will specify the compatible reversed typing red blood cells. Special attention should be paid to the microcolumn gel card product instructions regarding the specified reversed typing red blood cells.
How to Select the Worst-Case Samples for Mechanical Performance of Intervertebral Fusion Devices
When selecting the worst-case samples for the mechanical performance of intervertebral fusion devices, it is important to consider factors such as the size of the graft area, the size of the side holes, the angle of inclination, length, width, and height of different models and specifications of the fusion devices. These factors can affect the mechanical performance of the product. Additionally, since mechanical performance indicators vary (such as compression, compressive shear, torsion, etc.), the model and specifications of the worst-case samples may also differ. By integrating the methods and loading modes of the dynamic and static mechanical performance tests for cervical and thoracolumbar intervertebral fusion devices, a comprehensive consideration should be given to the selection of the worst-case samples for both cervical and thoracolumbar intervertebral fusion devices.
Ultrasound Imaging Equipment Used for Positioning on High-Intensity Focused Ultrasound (HIFU) Treatment Devices
It is recommended that ultrasound imaging equipment used for positioning not be considered part of the structural composition of HIFU products, but rather as accompanying equipment. If ultrasound imaging equipment is to be included as part of the product structure, documentation must be provided that meets all the requirements for imaging ultrasound equipment, including relevant standards and inspections, biocompatibility, sterilization, and acoustic output safety. If it is not part of the product composition and is used in conjunction with the product, it is advised to specify the specifications, model number, and software version of the accompanying product. Additionally, it should be demonstrated that it meets the requirements of section 5.4 related to positioning devices in YY 0592-2016.
When registering a dental mobile phone, do you need to reference the GB 9706.1 and YY 0505 standards?
Considering the lighting and power supply methods of dental mobile phones and connectors (if any), there are three types: with lighting devices, light-guiding, and without lighting. Structures with lighting devices include a light source; light-guiding structures do not contain a light source, only a bundle of optical fibers; structures without lighting neither contain a light source nor a light-guiding device. Structures with lighting devices should reference the GB 9706.1 and YY 0505 standards, while light-guiding and non-lighting types do not need to reference the GB 9706.1 and YY 0505 standards.