Investigation And Study In The Current Situation Of Establishment Of Medical Devices GLP In China

There has been a rapid progress made in the development of medical devices in China, especially the high-risk types (i.e. artificial joints, blood vessels and non-vascular interventional treatment products etc.).However, the safety issue of medical devices became increasingly the focus of attention due to the frequent occurrence of adverse events triggered by the misapplication of medical devices, which tragically caused a great harm to human health and tremendous losses in economic and social terms. As a solution, medical devices that have any direct or indirect contact with human bodies must undergo a process of a bio-safety evaluation, also known as apreclinical safety evaluation, prior to the application onto human bodies. Therefore, the preclinical safety studies of medical devices are by all means the very last bulwark of the medical device before applying onto the human bodies the first time, so that the quality of preclinical safety evaluation is a direct determinant of the level of risk of human application. At present, there is an absence of relevant quality management standard for the preclinical studies of medical devices which resulted in ineffective monitoring and assurance of the quality of preclinical safety research of medical devices.An indirect negative influence, nevertheless, will also be imposed on the safety issue in medical devices application during post-marketing stage. In conclusion, there is a great significance attached to the establishment and continuous improvement of the standardization of good laboratory practice of medical devices.The Good Laboratory Practice (GLP) is a quality system concerning the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, implemented, monitored, recorded, reported and archived. International Standard Organization (ISO) has promulgated and revised the "Biological evaluation of medical devices"(ISO 10993.1-20) in succession. Based on it, China has continued converting the existing standard into a national version "Medical Device Biological Evaluation" (GB/T16886.1-19) since 1992 and set up a National Medical Devices Biological Evaluation of Standardization Technical Committee (SAC/TC248) in 2001. China’s "good laboratory practice" series of national standards have become effective since April 2009, but so far the standard series have not yet applied into the preclinical safety evaluation of medical devices. In contrast, the preclinical safety evaluation of medical devices has been brought into the good laboratory practice study and implemented by mandatory enforcement in many developed countries and regional organizations. Therefore, the establishment of good laboratory practice of medical devices (hereinafter referred as "medical devices GLP") seems an inherent demand in terms of improving the quality of medical equipment management practices and strengthening a sound GLP system in China.The study reviewed the current situation of the preclinical study of medical devices in china by retrieving reference materials and literature and referring to the publication in relation to Biological Evaluation of Medical Devices and Drug GLP on journals and magazines published on the websites Pubmed and CNKI during the last 10 years.The study also browsed domestic and foreign medical device related web sites amounting nearly a hundred through search engines Baidu and Google, and summarized the experience of management and preclinical evaluation of medical device over a number of years as well as issued more than 1,000 questionnaires. By adopting the methodologies above, the study carried out a comprehensive analysis on the evaluation and problems of the medical device preclinical evaluation both domestically and abroad, as well as discussed the necessity, feasibility and influential factors of the application of GLP system and implementation of the pre-clinical evaluation of medical devices. The paper put forward ideas and priorities in development of medical device pre-clinical evaluation in China, proposed 13 systematic measures to regulate the development of medical devices preclinical evaluation in China.The main conclusions of this study are as follows:Firstly, an implementation of GLP standards in preclinical safety evaluation is not only necessary but also feasible. Analysis through investigation and empirical studies have shown that, on the one hand, implementation of the medical device preclinical evaluation requires to be GLP compliant urgently in all aspects of the work, whilst on the other hand, it may ensure the quality of medical devices pre-clinical study.Secondly, there is a strong tendency of demand to establish the medical devices GLP in the current stage of China. Through questionnaires, we found that the stakeholders of medical devices possess a consistent understanding of the defects in non-clinical safety, as well as a strong sense of identity in the improvement of the quality management of non-clinical safety studies of medical devices. These findings revealed an endogenous or inherent demand on the improvement of medical device quality of non-clinical safety studies from the stakeholders. As shown in some further analysis, the inherent demand indirectly reflected in the tendency of the needs in establishing the medical devices GLP in China.Thirdly, there are a variety of factors that affect the establishment of medical devices GLP in the current stage of China. Through the expert scoring and factor analysis methods, we found out the main factors which have impact on the establishment of medical devices GLP.These factors are listed in turn as follows:market, regulatory, cost, motivation for benefits, technology and organization aspects. Moreover, derived by matrix analysis we concluded that the medical device regulators, testing organizations and medical devices providers play important roles in the establishment of medical devices GLP.The last but not the least, the medical devices GLP should be based on general principles and elements of good laboratory practice in combination with the own characteristics of non-clinical safety studies of medical devices. This study has begun with five key elements of GLP respectively 1) research staff,2) experimental plan and set-up of standard implementation procedure,3) standardized management of various research resources,4) management of various research files and,5) verification and investigation by the research institutions; provided suggestions in establishing medical devices GLP in corporation with the characteristics of preclinical safety evaluation, which can provide preliminary train of thoughts and reference for the relevant authority in formulating regulations in medical devices GLP.