Based on the statistics of 350 technical evaluations of changes in licensing items of class Ⅱ passive and active medical devices completed in Henan province from July 2017 to November 2018, this paper summarized and analysed the common problems and requirements listed in the correction notifications of the technical evaluation, and put forward relevant countermeasures or suggestions, with a view to further speeding up the evaluation and approval of medical devices.
Equipment and Supplies ; standards ; Government Regulation ; Licensure

Recently, digital health has gained the attention of physicians, patients, and healthcare industries. Digital health, a broad umbrella term, can be defined as an emerging health area that uses brand new digital or medical technologies involving genomics, big data, wearables, mobile applications, and artificial intelligence. Digital health has been highlighted as a way of realizing precision medicine, and in addition is expected to become synonymous with health itself with the rapid digitization of all health-related data. In this article, we first define digital health by reviewing the diverse range of definitions among academia and government agencies. Based on these definitions, we then review the current status of digital health, mainly in Korea, suggest points that are missing from the discussion or ought to be added, and provide future directions of digital health in clinical practice by pointing out certain key points.
Artificial Intelligence ; Genomics ; Government Agencies ; Government Regulation ; Health Care Sector ; Humans ; Korea ; Mobile Applications ; Precision Medicine ; Telemedicine

Phentermine is a sympathomimetic amine, like amphetamine, which is one of the most often prescribed drugs for weight loss. Although exact mechanism of phentermine causing psychosis is still not clear, numerous reports already showed that phentermine can induce psychosis. Psychotic symptoms are generally resolved once the medications are stopped. In contrast, we present a case of a 25-years-old Asian female patient who developed psychotic symptoms repeatedly after phentermine administrations. This case suggests that phentermine can cause psychotic episodes repeatedly, resulting in chronic occupational and social impairment. Therefore, a precautious measure such as government regulations for physicians prescribing and an education for patients taking phentermine are urgently needed.
Amphetamine ; Asian Continental Ancestry Group ; Education ; Female ; Government Regulation ; Humans ; Phentermine ; Psychotic Disorders ; Recurrence ; Weight Loss

Cosmetics containing botanic ingredients have been used from thousands of years up to now in China. Because of the consumers' demand for health and beauty,the number of products about " botanic" have been growing rapidly in the cosmetics market,which has played an important role in upgrading the industry and enhancing the international competitiveness nowadays. Therefore,to strengthen the management about used botanic raw materials in cosmetics products and revise the application regulation of new raw materials has become an important work to ensure product quality,promote the healthy and stable development of cosmetic business. The article summarizes the related mandatory regulations and standards about botanic ingredients which used as activity function in major cosmetic business countries or regions. Furthermore,the information of botanic ingredients commonly used in non-special cosmetics notification and special cosmetic registration system were described to expect the better application and development.
China ; Consumer Product Safety ; Cosmetics/standards* ; Government Regulation ; Plant Preparations/standards*

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

Cupping therapy (Hijama in Arabic) is a popular traditional treatment especially in Asia, the Middle East and Central Europe. Traditionally, cupping therapy has been one of the most used practices in Saudi Arabia. Standardization of the practice of cupping therapy is a very important step to eliminate or reduce any adverse events related to cupping. This article gives a brief illustration and highlights the important points of the first accredited Saudi Arabian standards for the safe use of cupping equipment and its applications.
Equipment Safety ; standards ; Government Regulation ; Humans ; Medicine, Traditional ; instrumentation ; methods ; standards ; Safety ; standards ; Saudi Arabia

The concept of acute care surgery (ACS) incorporates trauma, surgical critical care, and emergency general surgery. It was designed in the early 2000s by the United States as a solution to the looming crisis of trauma care and non-trauma emergency surgery. Reduced surgical opportunities for trauma surgeons resulted in a decreased interest in trauma surgery. Surgical sub-specialization further accelerated an indifference towards trauma and emergency general surgery. Started in 2008, the trauma center project in Korea is still in its infancy. Although the need for ACS was presented since the inception of the trauma center project, there was a lack of implementation at trauma centers due to government regulations. However, ACS has been initiated at several non-trauma center hospitals and is mainly operated by surgical intensivists. Studies demonstrate that adding emergency surgery to a trauma service does not compromise the care of the injured patients, despite an increase in trauma volume. Positive impacts of ACS are reported by numerous researches. We believe that the development and advancement of trauma centers will necessitate a discussion for the implementation of the ACS model at trauma centers in Korea.
Critical Care ; Emergencies ; Government Regulation ; Humans ; Korea* ; Surgeons ; Trauma Centers ; United States

BACKGROUND: Acetylcholinesterase inhibitor insecticides (AChEIIs) were used extensively in the agrarian region of Anuradhapura for the past few decades. As a result, the region faced a heightened risk of toxicity. Carbaryl, carbofuran, chlorpyrifos, dimethoate, and fenthion were the five hazardous AChEIIs banned from Anuradhapura in 2014. Assessment of post-ban trends in acute poisoning will reveal the impact of the ban. Data on availability and sales of remaining AChEIIs will guide towards preventive measures against related toxicities. METHODS: Cross-sectional surveys were conducted at Anuradhapura district of Sri Lanka. Details related to acute AChEII poisoning were sorted from the Teaching Hospital Anuradhapura. Main insecticide vendors in Anuradhapura were surveyed to find information on availability and sales of AChEIIs. Chi-square for goodness of fit was performed for trends in acute poisoning and sales. RESULTS: Hospital admissions related to acute AChEII poisoning have declined from 554 in 2013 to 272 in 2017. Deaths related to acute AChEII poisoning have declined from 27 in 2013 to 13 in 2017. Sales of all five banned AChEIIs had reduced by 100%. Sales of the remaining AChEIIs were declining, except for acephate, phenthoate, and profenofos. However, one of the top selling, most frequently abused carbosulfan, had the highest risk of toxicity. Chi-square for goodness of fit showed a significance (P < 0.001) between the trends of hospital admissions for acute AChEII poisoning and the sales related to AChEIIs. CONCLUSIONS Hospital admissions related to acute poisoning was declining along with the overall sales of remaining AChEIIs, during the post-AChEII ban period. Nevertheless, future vigilance is needed on the remaining AChEIIs to predict and prevent related toxicities.
Agriculture ; legislation & jurisprudence ; Cholinesterase Inhibitors ; classification ; poisoning ; supply & distribution ; Commerce ; statistics & numerical data ; trends ; Cross-Sectional Studies ; Developing Countries ; Female ; Government Regulation ; Health Policy ; legislation & jurisprudence ; Hospitalization ; statistics & numerical data ; trends ; Humans ; Incidence ; Insecticides ; classification ; poisoning ; supply & distribution ; Male ; Poisoning ; epidemiology ; mortality ; prevention & control ; Risk Factors ; Sri Lanka ; epidemiology

According to the information of the supervision and inspection of in vitro diagnostic reagents for clinical use, this article analyzed the compliance issues and discussed the methods to solve the problems, to urge medical institutions to reduce the regulatory risk of in vitro diagnostic reagents in use.
Government Regulation ; Indicators and Reagents ; adverse effects ; Risk

The Korean Transplant Act has been revised five times since 1999, and each revision has resulted in a slight donation rate increased; however, the organ shortage had not been solved. As a result, further revision of the Transplant Act is needed. The current focuses solely on efficiency for transplantation. Therefore, this study suggests a paradigm shift in the revision of the act through the virtuous cycle for activating donation; namely, from an efficiency-based transplant system to a donor-centered transplant system.
Government Regulation ; Transplantation