The real-world data of Hainan Boao Lecheng International Tourism Pilot Zone has the advantage of supporting pre-market clinical evaluation of medical devices. Based on the relevant requirements of clinical evaluation of medical devices and based on the practical experience of pilot devices in the early stage, the application of Boao Lecheng real-world data in the pre-market clinical evaluation path of medical devices from the perspective of review is discussed. At the same time, the elements that should be considered in real-world study design and the way of data quality evaluation are proposed. Expect to provide a reference in order to allow registration applicants to use real world data wisely to help declare device registration for marketing.
Device Approval ; Marketing ; Research Design

Traditional Chinese medicine fumigation device is the carrier of traditional Chinese medicine fumigation treatment. In recent years, with the rapid development of new technology and new materials, the development of fumigation device changes with each passing day, and a variety of new products continue to emerge. However, at present, the lack of corresponding evaluation norms, resulting in some difficulties in the registration, marketing, quality control, evaluation scale and other aspects of the product. Some products have many disadvantages in clinical use. From the perspective of technical review, this paper elaborates and analyzes the main concerns in technical review, such as product structure, main risks, performance requirements, clinical evaluation, etc., in order to provide a basis for the design, development, production, registration, use and post-marketing supervision of the devices.
Fumigation ; Medicine, Chinese Traditional ; Marketing ; Quality Control

OBJECTIVE: Sort out and analyze the current status and existing problems of the pilot work of the medical device marketing authorization holder system to provide reference opinions for the full implementation of the medical device marketing authorization holder system. METHODS: Use literature analysis, comparative analysis and field research to comprehensively analyze the status, advantages and risks of commissioned production under the medical device marketing authorization holder system. RESULTS: The commissioned production under the medical device marketing authorization holder system brings dividends and also brings risks. CONCLUSIONS We should consider improving the medical device marketing authorization holder system from marketing authorization holder, the entrusted manufacturer, and the regulatory authority, and strengthen the quality supervision of the entrusted production of products.
China ; Marketing

In the perspective of technical evaluation, the pre-marketing regulatory requirements of allergen detection reagents in China, America, European Union were compared, and the regulatory risks and performance requirements of this product were analyzed based on the monitoring of post-marketing adverse events, reference standards and domestic and foreign regulatory documents. In view of the "neck-stuck" problems such as the difficulty of clinical trials, the difficulty of finding comparable contrast reagents and the lack of clinical diagnostic gold standards, this paper discusses and gives regulatory suggestions, with a view to providing technical reference for product R&D, production, evaluation, approval and supervision in this field.
Allergens ; European Union ; Indicators and Reagents ; Marketing ; Reference Standards

This study is based on the summary of the characteristics of quality variation of national medical device supervision and inspection in 2020. According to the results of the national medical device supervision and inspection through comparative analysis, this study puts forward suggestions on the medical device production and supervision measures for the post-marketing products, so as to further improve the level of the medical device and ensure the safety use of medical device.
Marketing ; Reference Standards

ABSTRACT This study investigated personal and professional social media use among orthodontists in Malaysia, to determine marketing strategies and to identify potential determinants associated with their behaviours. A cross sectional study using an online questionnaire distributed to members of the Malaysian Association of Orthodontists (MAO). Data were analysed using SPSS software to derive descriptive statistics and analysis of variance was applied to compare responses between age groups and working sector. Responses to open ended questions were analysed using thematic analysis. A response rate of 41% was obtained (n = 72). Almost all respondents were social media users with Facebook being the most common online platform. Majority relied on traditional methods of marketing such as good service and image practice (94.4%), word of mouth (94.4%) and referrals (93.1%). Only 9.7% of respondents had adopted social media marketing but 23.6% had future plans to adopt it as their marketing strategy. Difference in knowledge of social media marketing was significantly different between age groups (p = 0.024). Concerns over patient confidentiality (p = 0.016) and risk of breaching online professional behaviour (p = 0.025), as reasons discouraging social media marketing was statistically significant between work sector groups. Most orthodontists in Malaysia use social media for personal use but only a minority incorporate it into their marketing strategies. Majority see its potential and predict its use will increase in the future.
Orthodontics ; Social Marketing ; Malaysia

OBJECTIVE: This paper puts forward suggestions on the development of in vitro diagnostic reagents and supervision measures for the post-marketing products, so as to further improve the quality of in vitro diagnostic reagents and ensure the safety use of medical device. METHODS: This paper summarizes the quality of in vitro diagnostic reagents and analyzes the causes of the problems, according to the results of the national medical device supervision and inspection in 2020. RESULTS: The overall quality of in vitro diagnostic reagents for national medical device supervision and inspection in 2020 is stable and the unqualified detection rate is 1.6%. However, there are some problems. For example, the management of raw materials is unscientific, the faultiness in the preparation of reference materials, the understanding of standards is unthorough, and the management of instructions is unimportance. CONCLUSIONS It is suggested that manufacturers of in vitro diagnostic reagents should improve the binding force of the quality management system, strengthen the awareness of risk management, attach importance to communicate with regulatory authorities, study standards sufficiently and strengthen the management of instructions. It is also suggested that the regulatory authorities should strengthen supervision and inspection, and further complete the evaluation guidance and standard publicity and implementation.
Indicators and Reagents ; Marketing ; Reference Standards

Single-arm trial refers to a clinical trial design that does not set up parallel control group, adopts open design, and does not involve randomization and blind method. These features, on the one hand, speed up the process of clinical trials, significantly shorten the time to market and meet the needs of patients with advanced malignancies, but also lead to the uncertainty of single-arm clinical trials themselves. Recently, the US Food and Drug Administration held a meeting of the oncologic drug advisory committee to discuss six tumor indications that have been accelerated approved, which once again triggered the discussion of single-arm trials. The basis of accelerated approval by single-arm trial is actually a compromise on the level of evidence-based medical evidence requirements after assessing the benefit risk. Therefore, the sponsor should strictly grasp the applicable conditions of single-arm trial in anti-tumor drugs and conduct single-arm trial scientifically. Post-marketing clinical trial should be implement as early as possible to ensure the benefit of patients. Based on the characteristics of single-arm trial, combined with two guidance relevant to single-arm trial issued by National Medical Products Administration recently, this article is supposed to propose and summarize the strategy of single-arm trial supporting the marketing of anti-tumor drugs.
Antineoplastic Agents/therapeutic use* ; Clinical Trials as Topic ; Humans ; Marketing ; Neoplasms/drug therapy* ; Research Design ; United States ; United States Food and Drug Administration

Background: Health information systems (HIS) such as Electronic Medical Record (EMR) systems are essential in the integration of fragmented local health systems. Investing in HIS is crosscutting; it can address multiple interrelated health system gaps. However, public health authorities, especially those in resource-constrained communities, are often faced with the dual challenge of upgrading and digitalizing local HIS and addressing other more apparent health system gaps. Objectives: The study aimed to identify and document strategies that not only motivate policy change towards adoption of electronic HIS but also address other health system gaps. Methodology: The author, in his capacity as a local health official in a resource-constrained community, developed, implemented, and documented a social marketing strategy wherein community stakeholders were influenced to invest in an electronic medical record (EMR) system because it was shown to also have the capacity to address other priority health system gaps identified. Results: The strategy, based on situational, stakeholder, and risk analyses, prompted local governance to first invest in improving the delivery of services accredited by the national health insurance program (PhilHealth), for which reimbursements would require electronically submitted claim forms. Community stakeholders then supported the proposal to invest in an EMR system because they were persuaded that it can facilitate increased financing from PhilHealth claims reimbursements, which could be used to enable not only improvement in existing health services but to also initiate other health programs. Conclusion Social marketing using the perspective of health as an investment influenced stakeholders to invest in an EMR system.
Public Health ; Health Information Systems ; Health Communication ; Social Marketing

The article summarized the relevant researches on the clinical orientation of Chinese patent medicines, and put forward the post-marking principle and strategies of the clinical orientation. The principle could be illustrated by four criteria: overall design, step-by-step implementation, from easiness to hardness, gradual concentration. The strategies were as follows: first carrying out the projects with little cost of money and time, and then the projects requiring much cost of money and time, so that the possibility of fai-lure would be put forward at an early stage to reduce the loss caused by research failure as much as possible by consolidating the research projects with less investment at the early stage and gradually increasing the research projects with more investment at the later stage. On this basis, the "three dimensions and four stages" key technology was proposed for the post-marketing clinical orientation of traditional Chinese medicine. Medicines, diseases and patients were the "three dimensions", so we should understand the features and interaction of the target indications, symptoms and population to establish a three-dimensional clinical positioning coordinate system. "Four stages" were the four steps of clues analyzing, hypothesis orientation, preliminary verification and clinical validation. Each latter stage should be started after full completion of the former one, and the latter stage results shall be used to validate and revise the former clinical orientational hypothesis, continuously forming a feedback circle. Based on the sufficient verification of previous study, prospective clinical trials were implemented at last to get the best evidence-based evidence of clinical orientational hypothesis.
Drugs, Chinese Herbal ; Humans ; Marketing ; Medicine, Chinese Traditional ; Nonprescription Drugs ; Prospective Studies