Core Architecture and Clinical Application of Orthopedic Robot Based on Human-like Thinking / 中国医疗器械杂志

Intelligent and precision medical treatment is the future development trend of surgical operations. We proposed a core architecture of orthopedic robots with human-like thinking based on the growing demand for orthopedic robots and disadvantages of current robots, it consists of brain, eyes and hands three modules according to functions. The architecture design is extremely in line with the doctor's logic so that the work process of the orthopedic robot is similar to the process of traditional surgery which is mainly done by the doctor's brain-eye-hand coordination. It realizes the digitization of the doctor's thinking, the immediacy and visualization of surgical information and the accuracy of surgical operation process. The clinical application proved that the orthopedic robot has the advantages of higher accuracy, less radiation and shorter operation time, which can be further promoted clinically.

Analysis of Class II Common Problems in the Registration of / 中国医疗器械杂志

From the perspective of technical review, this paper made statistics on the supplement contents of

Research on Marketing Permission of Cross-border Transfer Production of Medical Devices / 中国医疗器械杂志

At present, there is a growing call for overseas registration applicants to transfer the products that have been approved for import registration to China's domestic production. It deserves our regulatory authorities to study how to face and properly deal with this issue. First of all, this paper systematically combs the regulatory requirements of FDA, EU and Japan on the change of manufacturing site address. Secondly, the paper briefly analyzes the current regulatory differences between domestic and imported devices. Finally, according to the experience and practice of foreign countries, combined with the actual situation of our country, this paper puts forward suggestions on how to meet the needs of overseas registrants to transfer products to domestic production.

Solution to Unify the Review of Domestic Second Class Medical Device / 中国医疗器械杂志

In October 2017, the General Office of the CPC Central Committee and the General Office of the State Council issued "The opinion on deepening the reform of the review and approval system and encouraging the innovation in pharmaceutical and medical devices" which clearly requires the unification of the evaluation stand for the second class medical device and realizes national review gradually. According to this requirement, this paper firstly reviews situation of foreign medical device evaluation system, and then introduces general situation of medical device review in our country, including the establishment of institutions and existed problem of medical device registrations, and corresponding reasons are also be analyzed. Finally we focus on giving proposal on how to realize the unification of class Ⅱ medical device technology review in China combined with real situation based on referring foreign experience.

Study of the Application of Mobile Medical Technology in Construction of Grading Diagnosis and Treatment System / 中国医疗器械杂志

The combination of mobile medical technology and the grading diagnosis and treatment system (GDTS) can stimulate the allocation of medical resources, reduce medical cost and improve public health significantly. Firstly we summarize development features of mobile medical technology in foreign and domestic market, then we study the application model of mobile medical application in GDTS with field research data and analyzes its advantage and shortage. Finally, we propose four measures for further developing mobile medical application in the GDTS:the government departments should formulate policies and industry standards of products as soon as possible to meet requirement of market; service providers should take the hospitals as core role to achieve mutual benefit and win-win situation; take the daily monitoring of chronic diseases as an entry point to build profitable business model; enhance publicity to promote public health awareness.