Key points for NMPA registration of microcatheters
1、 Introduction to microcatheters
Microchannels typically consist of a catheter body, radiopaque markers, connectors, and other structures. The tube body is usually thin and soft, and the surface may have a hydrophilic coating. Used for injecting diagnostic reagents (such as contrast agents), therapeutic reagents (such as drug preparations, embolic materials), and appropriate instruments (such as stents, coils) into the vascular system.
Microcatheter plays an indispensable and vital role in the field of interventional treatment of coronary atherosclerotic heart disease (CHD), especially in dealing with the challenging chronic occlusive disease (CTO). As the global incidence rate of cardiovascular diseases continues to rise, and patients increasingly pursue the safety and effectiveness of minimally invasive surgery, advanced catheter technology has become a key force to promote medical progress.
Microchannels, with their ultra-fine size, excellent flexibility, and precise maneuverability, perfectly meet the needs of complex coronary intervention surgeries. They can easily traverse winding, narrow, and even occluded blood vessel channels, providing doctors with unprecedented treatment pathways and achieving precise navigation and intervention of lesion sites. In the interventional treatment of complex lesions such as CTO, microcatheters not only improve the success rate of surgery, but also significantly reduce surgical risks, alleviate patient pain and recovery time.
At the market level, with the continuous innovation of medical technology and the continuous expansion of clinical application scope, the demand for the global microcatheter market is showing a strong growth trend. It is predicted that this market will experience significant expansion starting from $4.3925 million in 2023, and is expected to reach a market size of nearly $8.2469 million by 2032, with a significant compound annual growth rate, reflecting the broad application prospects and huge market potential of microcatheter technology in the field of cardiovascular intervention therapy (data source from the network).
In summary, as a key tool in the interventional treatment of coronary heart disease, especially in the treatment of CTO lesions, microcatheters are leading the innovation and development of cardiovascular intervention technology, bringing safer and more effective treatment options for cardiovascular disease patients worldwide.
In China, the management category of microcatheters is Class III, with a classification code of 03-13-26 microcatheters. This article provides a brief introduction to the key focus points of domestic registration of microcatheters based on the "Guiding Principles for Registration and Review of Microchannels (No. 4 of 2022)" and combined with the author's previous experience.
2、 Reference standards and guiding principles
YY 0285.1-2017 Intravascular catheters - Disposable sterile catheters - Part 1: General requirements;
GB/T 16886 series standards;
Guiding Principles for Registration and Review of Microchannels (No. 4 of 2022);
2、 Requirements for Writing Overview Materials
1. Product Name
Generally, "microcatheter" is used as the core word, with structural characteristics, material composition, and usage location as characteristic words, such as "coronary microcatheter".
2. Structural composition
Need to provide axial and cross-sectional views of the microcatheter; If the product is designed with a multi-layer structure, the multi-layer structure should be clearly identifiable on the cross-sectional view.
3. Composition materials
For raw materials that come into direct/indirect contact with the human body, supplier information, manufacturer information, proof of purchase documents, quality control standards, and factory inspection reports are required.
For products with coatings, the coating range and method need to be provided; For hydrophilic coatings containing hyaluronic acid, the source of hyaluronic acid should be clearly identified, indicating whether it is extracted from animal tissue or prepared through microbial fermentation.
3、 Non clinical data
1. Product Technical Requirements
The performance indicators in the product technical requirements should refer to Table 1 in the attachment of the Guiding Principles for Registration and Review of Microchannels (No. 4 of 2022). If the project is not applicable, the reasons should be explained.
For coated products, if the coating material causes abnormal chemical performance results, it is recommended to test uncoated products to confirm whether their chemical properties are acceptable. At the same time, a comprehensive evaluation should be conducted based on the clinical application history and biocompatibility data of the coating material. If the coating can be safely used on the human body and the chemical properties of the uncoated product are normal, this chemical property may not be specified in the product technical requirements. (Tips: Chemical performance testing can be conducted only on the parts in contact with the human body. If the test results are qualified, the evaluation is also acceptable. Therefore, the safety of the product should be analyzed from multiple aspects.). ）
2. Product performance research
The performance indicators listed in Appendix Table 1 of the Guiding Principles for Registration and Review of Microchannels (No. 4 of 2022) should provide determination basis and performance research data. If not applicable, reasons should be explained.
The performance research data should clearly specify the sample size and the basis for determining the sample size.
3. Stability study
The shelf life verification project includes two aspects: product performance and packaging system performance, among which the product performance should include all the performance specified in the product technical requirements (especially when registering for import)
4、 Clinical evaluation
Microcatheters are products listed in the "Catalogue of Medical Devices Exempted from Clinical Evaluation". If they exceed the requirements of the clinical exemption catalogue, they can refer to the "Guidelines for Technical Review of Comparative Clinical Evaluation of Intravascular Catheters of the Same Variety" for clinical evaluation or clinical trials of the same variety.
