TX Q&A

The "CMDE" WeChat public account article from July 2019, "How should the supplier of the main raw materials in the appendix of the technical requirements for in vitro diagnostic reagent products be filled out?" emphasized that the supplier should be the manufacturer of the raw materials, not a distributor or agent. Accordingly, changes in the registration situation involving the supplier of the main raw materials refer to cases where the manufacturer of the raw materials changes. It should be noted that not all changes in the manufacturer of the main raw materials can be declared as a registration change. For example, changes in the manufacturer that lead to substantial changes in antigens and antibodies, changes in primer probe sequences, etc., are considered major changes in product design and should be declared as a new registration.

The posterior spinal elastic fusion fixation system, used for posterior spinal fusion fixation and different from the posterior spinal rigid internal fixation system used for fusion, should be divided into different registration units. Products with different structural designs and mechanical properties should be classified into different registration units. Products that mainly function due to different materials should be divided into different registration units. If the materials of the product components are different, but the product is used as a whole assembly or combination, it can be declared under the same registration unit.

When in vitro diagnostic reagent testing samples involve different anticoagulants, research on different anticoagulants should be conducted during the preclinical research stage to verify the applicability of the anticoagulants and their impact on testing. Generally, if preliminary research suggests that the anticoagulants claimed to be usable in the instructions do not have a differential impact on sample testing, it is not necessary to group and include samples using different anticoagulants during the clinical trial process; all applicable anticoagulants can be used in the clinical trial samples. In special cases, when different anticoagulants significantly affect the test results, leading to different reference values for clinical test result determination, sample collection and research should be conducted separately in the clinical trials. The clinical trial protocol and report should clearly specify the sample types and the anticoagulants used in the samples.

When naming active medical devices, refer to the examples of product names in the "Medical Device Classification Catalog", applicable industry standards, national standards, and other documents for naming. When a product only meets the requirements of the GB 9706.1-2007 standard, it is not recommended to include the word "system" in the product name. The word "system" can be used in the product name when the product meets both the GB 9706.1-2007 and GB 9706.15-2008 standards.

The stent part and the delivery system should be evaluated for cytotoxicity separately. If the drug-containing part of the stent shows high cytotoxicity, a cause analysis should be conducted, followed by a comprehensive evaluation. For example, when cytotoxicity is considered to be caused by the drug, cytotoxicity tests for both the bare stent and the drug-containing stent should be carried out separately, and a risk analysis of the cytotoxicity of the drug-containing stent should be performed, along with a comprehensive evaluation of the impact of the included drug.

The "Catalog of Medical Devices Exempt from Clinical Trials (Revised)" (referred to as the exemption catalog) describes the structure of electronic nasopharyngolaryngoscope products as "generally consisting of a head end, a bending part, an insertion part, an operating part, and parts connected to electrical and light sources. The photoelectric converter at the head end converts the received optical signals into electrical signals, which are observed on a monitor through a camera system. The video monitor provides images for observation, diagnosis, and photography of the nasopharynx and larynx." The products in the exemption catalog refer to common electronic nasopharyngolaryngoscopes that connect to traditional external endoscope cold light sources and image processing devices (i.e., camera systems), where the light source is connected through an endoscope illumination fiber optic cable to the cold light source. An electronic nasopharyngolaryngoscope with a built-in light source already includes a light source and does not require an external cold light source, differing from the structural composition of products in the exemption catalog, and therefore, it is not considered an exempt product.

1. The medical device registration certificate already includes sodium bicarbonate B powder models. 2. The proposed new online-use sodium bicarbonate B dry powder model has the same formula as the original, only replacing the original sodium bicarbonate B powder and agent A for preparation, with no change in the types and concentrations of ions in the resulting dialysis concentrate. When both of the above conditions are met, it is not necessary to provide clinical evaluation documents.

For products in the exemption from clinical trials catalog, such as interleukin test reagents, where the catalog describes the use as "for detecting interleukins in human samples, mainly used for monitoring the body's immune status, inflammatory responses, etc.", there are many types of interleukins. Products claiming to fit the above uses for various interleukin detection items can be declared as exempt from clinical trials. If the product has a new intended use, such as for the auxiliary diagnosis of specific pathogen infections, then it does not qualify for clinical trial exemption. For blood gas test reagents, the catalog describes the use as "used in conjunction with blood gas analysis systems to determine pH value, carbon dioxide partial pressure (pCO2), oxygen partial pressure (pO2), hematocrit, concentrations of sodium, potassium, and calcium ions, and other electrolyte analyses in human samples. Clinically, it is mainly used to monitor imbalances in acid-base balance, hypoxia, and carbon dioxide retention, etc." Products being declared that include testing items beyond the described content, such as chloride ions, oxyhemoglobin, blood oxygen saturation, and other routine blood gas testing items, can also be declared as exempt from clinical trials.

For medical devices in contact with circulating blood, according to the "Guidelines for Writing Technical Requirements for Medical Device Products," bacterial endotoxins need to be specified in the technical requirements. Pyrogen items can be provided in the biocompatibility study data. When registering the product, both bacterial endotoxins and pyrogens need to be studied.

During the product design and development process, the manufacturer should fully consider the impact of processing aids on product performance. This includes clarifying the usage and selection basis of processing aids, specifying the cleaning methods for processing aids, and providing corresponding cleaning validation documents. For the residues of processing aids after cleaning, clear acceptable standards should be established, along with the basis for determining these standards, ensuring they do not affect the safety and effectiveness of the final product.