In China, the regulatory framework for medical device procurement and sales, particularly concerning anti-commercial bribery, relies heavily on punitive mechanisms applied after violations occur. Consequently, there is an urgent need to establish a scientific risk regulation framework as a complementary approach. Effective risk-oriented regulatory models require precise identification of risk areas in commercial bribery. Focusing on several major procurement scenarios such as centralized bulk-buying, tendering and bidding processes, in-hospital procurement, and online purchasing, this article analyzes the structural factors contributing to these risks, represented by the absence of certification mechanisms, lack of transparency in information disclosure, and inadequate checks and balances. Based on official risk assessment results, this study applies the theory of power and responsibility to propose a preventive regulatory framework that combines industry self-discipline and administrative oversight. By combining these approaches, the framework aims to develop regulatory measures that can effectively reduce commercial bribery risks and prevent illegal and non-compliant conduct.
China ; Equipment and Supplies/economics* ; Commerce/legislation & jurisprudence* ; Humans ; Risk Assessment

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

This paper introduced the overview of the "eight trends" of Chinese medicinal materials(CMM) industry in 2021, analyzed the problems of CMM production, and put forward development suggestions. Specifically, "eight trends" could be summarized as follows.(1) The growing area of CMM tended to be stable, and some provinces began to release the local catalog of Dao-di herbs.(2) The protection process of new varieties accelerated, and a number of excellent varieties were bred.(3) The theory of ecological cultivation was further enriched, and the demonstration effect of ecological cultivation technology was prominent.(4) Some CMM realized complete mechanization and formed typical model cases.(5) The number of cultivation bases using the traceability platform increased, and provincial internet trading platforms were set up.(6) The construction of CMM industrial clusters accelerated, and the number of provincial-level regional brands increased rapidly.(7) Many new agricultural business entities were founded nationwide, and a variety of methods were used to drive the intensified development of CMM.(8) A number of local TCM laws were promulgated, and the management regulation of food and medicine homology substances catalogs was issued. On this basis, four suggestions for CMM production were proposed.(1) It is suggested to speed up the formulation of the national catalog of Dao-di herbs and carry out the certification of Dao-di herbs production bases.(2) Ecological planting of forest and grassland medicine should be further strengthened in terms of technical research and promotion based on the principle of ecological priority.(3) The basic work of disaster prevention should be paid more attention and technical measures for disaster mitigation should be developed.(4) The planted area of commonly used CMM should be incorporated into the national regular statistical system.
Agriculture ; Certification ; Commerce ; Industry ; China

With the characteristics of fast prototyping and personalized manufacturing, 3D-printing (three-dimensional printing) is an emerging technology with promising applications for orthopedic medical devices. It can complete the process of medical devices with complex shape which can not be completed by conventional fabrication process. At present, a variety of orthopedic medical devices manufactured by 3D printing technology, has been approved for marketing, and their use has been proved to be beneficial. 3D bioprinting in this area has also made a few breakthroughs. However, many challenges still remain to be addressed as well. In this study, the research status, as well as the development of the 3D-printing technology in the field of orthopedic medical devices is elaborated.
Printing, Three-Dimensional ; Bioprinting ; Commerce ; Research

Through the analysis of laws and policies related to registration self-inspection, visiting and researching enterprises, holding symposiums, and issuing nationwide questionnaires, the risks in the registration self-inspection process were summarized, analyzed, and evaluated. From the aspects of regulatory departments and manufacturing enterprises, we suggest to improve China's medical device registration regulations system and reduce the risks of all parties in the registration self-inspection work.
Risk Management ; Commerce ; Medical Device Legislation

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: To interpret the key contents of the guidance of Personalized Medical Device Regulatory Pathways issued by the IMDRF, and provide reference for the improvement of China's medical device regulatory system. METHODS: The regulatory requirements of personalized medical devices and point-of-care manufacture of medical device were described respectively, and the feasibility of implementing the regulation of point-of-care manufacture of medical device in China was analyzed. RESULTS: The different regulatory pathways of medical devices produced at point-of-care are feasible and have different regulatory risks. CONCLUSIONS In combination with the recommendations provided by the IMDRF guidance and the clinical and regulatory realities in China, we should accelerate the improvement of the regulations and supporting documents for point-of-care manufacture of medical device in China.
Commerce ; Medical Device Legislation ; China

In the context of Pharma 4.0, the design tools that support the pharmaceutical Quality by Design(QbD) are iterating fast toward intelligent or smart design. The conventional development methods for traditional Chinese medicine(TCM) preparations have the limitations such as over dependence on experience, low dimensions for the designed experiment parameters, poor compatibility between the process and equipment, and high trial-and-error cost during process scale-up. Therefore, this paper innovatively proposed the intelligent co-design involving material, process, and equipment for manufacturing high-quality TCM preparations, and introduced the design philosophy, targets, tools, and applications with TCM oral solid dosage(OSD) as an example. In terms of design philosophy, the pharmaceutical design tetrahedron composed of critical material attributes, critical process parameters, critical equipment attributes, and critical quality attributes was developed. The design targets were put forward based on the product performance classification system. The design tools involve a design platform that contains several modules, such a as the iTCM material database, the processing route classification system, the system modeling and simulation, and reliability-based optimization. The roles of different modules in obtaining essential and universal design knowledge of the key common manufacturing units were introduced. At last, the applications of the co-design methodology involving material, process, and equipment in the high shear wet granulation process development and the improvement of the dissolving or dispersion capability of TCM formula granules are illustrated. The research on advanced pharmaceutical design theory and methodology will help enhance the efficiency and reliability of drug development, improve the product quality, and promote the innovation of high-end TCM products across the industry.
Medicine, Chinese Traditional ; Reproducibility of Results ; Quality Control ; Computer Simulation ; Commerce ; Pharmaceutical Preparations ; Drugs, Chinese Herbal

Arbovirus is a group of virus transmitted by blood-sucking arthropod bites, which infects both arthropods and vertebrates. More than 600 arboviruses have been characterized worldwide until now, including 65 highly pathogenic viruses, which pose a high threat to public health. The risk of arbovirus transmission is increasing due to climate change, international trade and urbanization. The review summarizes the discovery and distribution of emerging and reemerging arboviruses and novel arboviruses with potential pathogenic risks, and proposes responses to the arbovirus transmission risk, so as to provide insights into the research and management of arboviruses and arthropod-borne infectious diseases in China.
Animals ; Humans ; Arboviruses/physiology* ; Commerce ; Internationality ; Arbovirus Infections/prevention & control* ; Vertebrates

Focusing on the development and quality improvement strategy of the traditional Chinese medicine(TCM) industry, the scientific and technological innovation of the new engineering of TCM should be paid attention to solve the "stuck neck" dilemma. Under the background of the ecological and industrial revolution of the scientific and technological innovation system, the super-scale information interaction and multi-dimensional integration will inevitably lead to profound changes in the manufacturing mode of TCM. Manufacturing measurement of TCM is formed on the basis of the reliability engineering theory of process control of TCM production. It is the development extension of system theory and system science ideas and a cross-fertilization discipline that combines theory with practice and adheres to the "four-oriented" re-epistemology improvement of the TCM discipline. In response to the problems of complex raw material sources, coarse process technology, unclear material basis, and poor applicability of equipment and technology in the manufacture of TCM, the transformation research mode of "aiming at the integration of pharmaceutical industry-developing intelligent production line-enabling industrial transformation" has been developed. This paper proposed the four key engineering technical problems, i.e., the identification of critical quality attributes(CQA) in the manufacture of TCM, the quality by design(QbD) and product development of the manufacturing process of TCM, the quality transfer principle and multivariate process capability index of TCM manufacturing, and the development of measurement technology and equipment of the manufacturing measurement of TCM, to achieve the systematization of quality control indicators, real-time process control, digitalization of manufacturing process, transparency of quality transfer, and intelligent whole-process control. In this paper, the new concepts, new theories, and new technologies provide a reference for the industrialization of TCM.
Medicine, Chinese Traditional ; Reproducibility of Results ; Commerce ; Drug Industry ; Quality Control