The rapid development of nanomaterials has brought groundbreaking opportunities for high-quality innovation in medical devices, but it has also become a new challenge for regulatory authorities. How to scientifically and rationally evaluate the risks of medical device products with nanomaterials and establish appropriate regulatory classifications have become critical research priorities. To solve this problem, this study focuses on medical devices with nanomaterials, conducts a comparative analysis of domestic and international regulatory classification policies, reviews the current registration status of related products, and provides recommendations on key considerations for the classification and regulation of medical devices with nanomaterials, which aims at promoting high-quality advancement in China's medical device regulation.
Nanostructures/classification* ; Equipment and Supplies/classification*

OBJECTIVES: The aims of this study were to investigate the psychopathology in adolescents with internalizing disorder using the self-report version of Strengths and Difficulties Questionnaire (SDQ-SR) and the Minnesota Multiphasic Personality Inventory for adolescents (MMPI-A), and to explore the complementarity between these two inventories for diagnostic assessment. METHODS: Ninety-one patients aged 13–17 were divided into two groups by clinical diagnosis, 44 with internalizing disorder and 47 comparison group with other disorders. The data of SDQ-SR and MMPI-A completed by them were analyzed for the ability to predict internalizing disorder. RESULTS: The logistic regression analysis revealed that diagnostic predictability increased by 2.27 times with every 1 point of SDQ-SR emotional symptom score increment. Comparison of ROC curves for internalizing disorders showed that the SE and SP of SDQ-SR emotional symptom with score over 4 was 88.94 and 78.72, respectively. For A-anx of MMPI-A with score over 56, SE and SP was 77.27 and 74.47, respectively. However, combination of these scales could not enhance the predictability of diagnostic classification more than that of SDQ-SR emotional symptom alone. CONCLUSIONS: Emotional symptom scale of SDQ-SR and A-anx, A-aln, A and INTR of MMPI-A should be important subscales for diagnosing the internalizing disorder of adolescents, however, which needs to be examined further with a larger sample size including normal control group.
Adolescent ; Classification ; Diagnosis ; Equipment and Supplies ; Humans ; Logistic Models ; MMPI ; Psychopathology ; ROC Curve ; Sample Size ; Weights and Measures

OBJECTIVESTo increase the number and quality of adverse events reported in medical devices, dealing with adverse events that have occurred in time, preventing the occurrence of adverse events, and ensuring the safety of device use.

METHODSBased on risk management methods, through a comprehensive analysis of risk of adverse events, scientifically assessing the risk level and completing the classification of adverse events. Administrative supervision departments take corresponding supervision measures according to the classification results.

RESULTSBuilding a classification monitoring model of medical device adverse events based on risk management.

CONCLUSIONSThe classification of adverse events will help the administrative supervision department to focus on the work, reduce the workload, and improve the efficiency of supervision.

By comparing new medical device regulations with existing directives in the European Union, the revising ideas of new EU medical device regulations, especially the changes of the classification management concepts, were analyzed to provide clues for the industry to interpret the new EU regulations, and references for the classification management innovation in our country.
Equipment and Supplies ; classification ; European Union ; Government Regulation ; Industry

Fundamental difficulties in psychiatric nosology lie in the most basic fact that it deals with subjective states of the human mind. Modern instrumental diagnostic classification systems, which amount to lists of symptom inventories, could not provide accurate concepts of psychiatric disorders. This is also true for schizophrenia, a representative mental disorder. Kraepelin's dementia praecox was a collection of controversially proposed diseases, which had some critical similarities in their clinical features, i.e., the course and outcome. Despite initial debates on the adequacy of this concept, dementia praecox was recognized as a disease entity quite early, so that the concept of dementia praecox or schizophrenia proliferated, became diversified, and was then altered. We can now find large discrepancies between Kraepelin's dementia praecox and today's schizophrenia. However, the myth of disease entity was seldom challenged and psychiatrists today implicitly believe that they are dealing with what Kraepelin had proposed. In order to navigate this impasse, we thought that historical studies on the concept of dementia praecox and underlying taxonomic principles established by 19th century alienists including Kraepelin would shed some light. The aim of this article is to comprehensively review the history of concepts of dementia praecox or schizophrenia, and to question critically how much today's schizophrenia has received the conceptual inheritance from original concepts. Through this process, we expect to attain a renewed understanding of schizophrenia.
Classification ; Equipment and Supplies ; Humans ; Mental Disorders ; Psychiatry ; Schizophrenia* ; Wills

In this study, the Korean veterinary medical devices management system was evaluated relative to systems in the USA, EU, and Japan. Veterinary medical devices are regulated in Korea based on the Medical Appliance Act of 1997. This was initially supervised by the Ministry of Agriculture, Food and Rural Affairs and Korea Animal Health Products Association, and subsequently by the Animal and Plant Quarantine Agency (QIA) in 2000. These devices were classified approximately 1,400 categories as instruments, supplies, artificial insemination apparatus, and other categories. Each of these devices was assigned to four regulatory grades by the QIA in 2007. The ranking system for veterinary medical devices was implemented in 2014 with 820 products from 162 companies registered by that year. However, in vitro diagnostic devices (IVDDs) for animals were managed as medical devices and biological medicine. In vitro diagnostic reagents for treating infection diseases are not subjected to either a classification or grading system. Veterinary medical devices are currently exempt from good manufacturing practices (GMP) and device tracking requirements. Due to gradual growth of the domestic veterinary medical devices market since 2008, regulation of these devices should be improved with re-examination of IVDDs and GMP certification for the effective operating system.
Agriculture ; Animals ; Certification ; Classification ; Equipment and Supplies ; Indicators and Reagents ; Insemination, Artificial ; Japan ; Korea ; Plants ; Quarantine ; Reagent Kits, Diagnostic

Establish normal classifier of non-charge medical consumable and database of medical consumable inuse, is the basis of uniform classification and management of non-charge medical materials used in different hospital. It's an objective and effective method to classify by AI and set up the database, and has better classification accuracy.
Artificial Intelligence ; Databases, Factual ; Equipment and Supplies ; classification ; Materials Management, Hospital ; methods

This paper introduced the medical device classification in China and USA. Through the comparison between the two systems, several problems in Chinese classification system were exposed. To the end, some suggestions were proposed referred to the classification system of USA.
China ; Device Approval ; standards ; Equipment and Supplies ; classification ; United States

By analysis on existing problems of the classification, the suggestions were put forward to provide a reference for improving the classification of medical devices.
Equipment and Supplies ; classification

The codes of medical consumptive materials is the base for standardized and information management. This article analyzes in detail the structure and meanings of five common-used classification codes in management including registration certificate code, bar code of high-value medical consumptive materials, charging code, medical insurance code and account code. The disadvantages of current coding method and solving program are suggested.
Automatic Data Processing ; Clinical Coding ; methods ; Equipment and Supplies ; classification