In Vitro Diagnostic Instruments typically refer to medical devices that detect or process human samples outside the body to obtain clinical diagnostic information, thereby assessing diseases or bodily functions. In Vitro Diagnostic instruments generally need to be used in conjunction with other instruments or reagent kits to achieve the purpose of In Vitro Diagnosis (IVD). With the rapid development of the in vitro diagnostic industry, these instruments have become an important component of modern medical methods. They are not only a hot topic for application but also raise concerns about how to ensure their safety and effectiveness, which are key issues for manufacturers and the industry.
According to the “Medical Device Classification Catalog” standard, In Vitro Diagnostic instruments fall under the category of “22 Clinical Testing Instruments”, which includes equipment, instruments, auxiliary devices, and medical low-temperature storage equipment used in clinical testing laboratories. Currently, the main types of in vitro diagnostic instruments approved both domestically and internationally include: (1) Clinical testing analysis equipment, such as immunoassay analyzers, biochemical analyzers, blood glucose meters, urine analyzers, nucleic acid amplification analyzers, etc.; (2) Sample culture or processing equipment, such as fluorescence staining instruments, nucleic acid extraction instruments, anaerobic incubators, etc.; (3) Testing and other auxiliary equipment, such as microplate washers, sample processing systems, automated sampling systems, etc.
As a broad category, in vitro diagnostic instruments encompass many types of products. Given that the intended use of these instruments is related to clinical testing, there are some differences in product characteristics compared to other medical devices, which require special attention during design and registration processes. Therefore, referencing relevant technical standards from home and abroad, combined with the characteristics of these instruments, the following key technical issues that should be focused on during the registration of such instruments are discussed.
1. Product Performance
One of the requirements distinguishing in vitro diagnostic instruments from other medical devices is that they must conduct clinical project analysis performance studies. Comprehensive consideration of the conditions of the detected substances and the main functions (e.g., quantitative/qualitative analysis, different detection methods/modes, etc.) is required. Representative projects should be selected for research based on different types of analytes and the various functions of the instruments, which should be repeated multiple times and include confirmation and validation processes. Research projects generally include accuracy, repeatability, linearity, stability, contamination carryover, etc.
Safety indicators mainly include electrical safety indicators and electromagnetic compatibility indicators, among others. Applicants may conduct their own research on the above projects or verify them through commissioned testing. If the differences in product design structure do not significantly affect safety and effectiveness, typical models within the same registration unit may be selected for electrical safety performance testing; however, the electromagnetic compatibility performance between different model products often cannot be generalized.
Additionally, the performance of each component module should also be evaluated.
2. Product Validity Period
The conditions and duration of product use should be determined and clearly stated in the instructions.
There are many methods for determining the validity period of such products, which can be based on the product of the single cycle life of key components and the maximum number of replacements allowed, or determined through fatigue testing or accelerated testing methods.
3. Cleaning/Disinfection
Due to the use of human samples, corresponding measures should be taken in product design and usage instructions to reduce the risk of pathogen transmission. Research and validation on cleaning/disinfection should be conducted, specifying validated cleaning/disinfection agents, procedures, and cycles. The cleaning/disinfection methods should achieve the intended effects (e.g., resisting pathogenic microorganisms) and should not affect the main performance of the instruments.
4. Clinical Research
In vitro diagnostic instruments generally require clinical trial research with matching reagent kits, and attention should be paid to whether the claims of the matching reagent kits are consistent with the instructions. Clinical research is generally similar to other medical device methods, and relevant guidelines should be referenced.
5. Product Technical Requirements
These should be compiled according to the “Guidelines for Writing Technical Requirements for Medical Device Products”, including product name, product model/specification and its classification description, performance indicators, inspection methods, and basic safety characteristics appendix, etc. Sometimes specific analytical performance, such as accuracy, precision, sensitivity, compliance rate, etc., must also be included. The appendix should clarify the following four aspects: environmental conditions, type of equipment, power supply, and insulation.
6. Software and Network Security
Specific requirements can refer to the “Guidelines for the Review of Medical Device Software Registration” and the “Guidelines for the Review of Medical Device Network Security Registration”.
7. Others
In the research materials section, it should be noted that if the product already has corresponding industry standards published, it should meet all the requirements of those standards. The above items may not apply to all products, and applicants should conduct relevant research based on the specific circumstances of their products.
The setting of various indicators for the product should have sufficient basis and relevant research and validation materials should be submitted during the application process. If there are technical innovations, they should also be clearly stated in the materials and supported with relevant literature and data.
In vitro diagnostic instruments come in many varieties, with a wide range of applications and intended uses. During the product evaluation process, it is essential to consider the characteristics of the products and reference relevant domestic and international standards, documents, and guidelines to focus on key technical issues, ensuring a more comprehensive and scientific evaluation of the products to guarantee better safety and effectiveness.
References:
[1] Yuan Yinch, Zhao Xiaoqin, Chen Daming, et al. Overview of R&D and Market Development of In Vitro Diagnostic Reagents[J]. Biological Industry Technology, 2017(04): 16-24.
[2] Former State Food and Drug Administration. Announcement on the Release of the Medical Device Classification Catalog (2017 No. 104) [EB/OL]. [2017-09-04].
[3] Dong Jinchun. Basic Points for the Review of Fully Automatic Blood Type Analyzers[J]. Biotechnology Communications, 2016, 27(03): 405-408.
[4] Yang Zheng, Liu Ru. A Brief Discussion on the Testing of In Vitro Diagnostic Medical Devices[J]. China Medical Device Information, 2013, 19(12): 50-51+62.
[5] Shao Xiuwen, Qin Qilu, Zhang Wenzhong. Some Precautions in the Electrical Safety Inspection of In Vitro Diagnostic Equipment[J]. China Medical Device Information, 2017, 23(14): 14-15+18.
[6] Wu Kun. Methods for Determining the Validity Period of In Vitro Diagnostic Medical Devices and Their Significance[J]. Medical Health Equipment, 2017, 38(07): 122-124.
[7] Cui Jia, Wu Liyuan. Risk Analysis and Countermeasures for In Vitro Diagnostic Medical Devices in Use[J]. China Medical Device Information, 2016, 22(21): 29-30+50.
Review by Liu Yi, provided by the Evaluation Division
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