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Exploration of the Regulatory Approach to Medical Devices under the New Situation
2019-11-27
With rapid technological advancements, innovations in the medical device field are constantly emerging. Innovative medical devices and new business models are reshaping the medical device industry and presenting new challenges for medical device regulation. To effectively regulate medical devices under the new circumstances, we must first clearly understand the challenges facing current regulatory work, implement targeted measures, develop effective regulatory strategies, and continuously overcome regulatory difficulties in practice. New Challenges in Medical Device Regulation Strengthening Regulatory Teams Currently, China's medical device regulation faces challenges such as insufficient regulatory personnel, a lack of professionalization within regulatory teams, and more.
Analysis of Sales Scale and Market Concentration in China's Medical Device Industry
2019-11-26
According to the statistical data released in the "2018-2023 China Big Health Industry Competition Analysis and Investment Risk Prediction Report" by the Zhongyan Industry Research Institute, the current situation of China's medical device industry is as follows: I. Analysis of industry sales scale With the improvement of the living standards and the enhancement of the medical and health awareness of Chinese residents, the demand for medical device products continues to grow. Influenced by national support policies for the medical device industry, the domestic medical device industry has entered a stage of rapid growth. Data shows that from 2010 to 2016, the domestic medical device market size increased from 126 billion yuan in 2010 to 4484 in 2017
Top Ten Medical Device Unicorns in China
2019-11-22
1. United Imaging Healthcare: A Leading Domestic Manufacturer of High-End Medical Equipment
United Imaging, headquartered in Jiading, Shanghai, was established in October 2010. Within a few years, through capital investment and technological innovation, it has rapidly built a global competitive advantage in the medical imaging industry. It has established multiple product divisions, including molecular imaging (MI), computed tomography (CT), radiotherapy (RT), X-ray, and AI intelligence. Through an open talent development platform, it has gathered hundreds of highly skilled professionals globally. Currently, it has released 14 system products and 4 software products for medical imaging equipment operation. Among them is the 96-slice ultra-high-speed P...
2019-11-21
Medical device exports are increasing, but weaknesses remain. Medical device exports have increased significantly. On November 19, the State Council website forwarded an article from the People's Daily, which pointed out that in the first 10 months, China's total import and export value reached 25.63 trillion yuan, an increase of 2.4% year-on-year, of which exports reached 13.99 trillion yuan, an increase of 4.9%. Against the backdrop of sluggish global trade and investment, and in the face of a challenging and uncertain development environment, China's import and export volume has remained generally stable, its structure has continued to improve, and its quality has steadily improved. In the first 10 months, general trade, which has a longer domestic industrial chain and better reflects China's independent foreign trade, ...
2019-11-20
The medical device industry involves medicine, machinery, electronic information, bioengineering, materials science, and other fields. It is a multidisciplinary, knowledge-intensive, and capital-intensive emerging industry. Compared with developed countries, China's medical device industry has a weak foundation. At the same time, the huge and growing social medical needs have stimulated the rapid growth of the domestic medical device market. In recent years, the growth rate of China's medical device market has been significantly higher than that of other countries. With the rapid development of the industry, more high-tech medical device products have been launched, bringing new challenges to medical device supervision and higher requirements for the overall quality and ability building of the regulatory team.
2019-11-18
Medical Device Enterprises in Guangdong Province: In accordance with the requirements of the "Guangdong Province Medical Device Registrant System Pilot Program Implementation Plan," the Guangdong Provincial Medical Device Management Association, in cooperation with the Guangdong Provincial Drug Supervision and Administration Bureau, organized industry experts to draft and solicit opinions from some enterprises and research institutions, and revised the supporting recommended document for the medical device registrant pilot program, "Guangdong Province Medical Device Registrant System Medical Device Production Enterprise Production Release Implementation Guide" (hereinafter referred to as the Guide), which is now open for comments. Please submit your comments on the Guide in electronic format to the Association's email address after receiving this notice.
2019-11-15
In the third-quarter report released in October, medical device companies showed impressive achievements. In the third quarter, Mindray Medical's operating revenue increased by 20.24% year-on-year. The Shenzhen Stock Exchange's "Analysis of the Performance of Listed Companies in the First Three Quarters of 2019" points out that, by industry, the average net profit of the ChiNext pharmaceutical and biological industry in the first three quarters reached 237 million yuan, and the net profit growth of the pharmaceutical and biological industries also reached more than 20%, with the net profit growth rate reaching more than 40%. In recent years, the domestic medical device industry has shown vigorous development. Jointly organized by the Shenzhen Municipal Food and Drug Supervision Administration and the Shenzhen Medical Device Industry Association