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Regulations on the Classification and Supervision of Medical Device Businesses
2019-11-14
Chapter 1 General Provisions Article 1 To improve the scientific level of supervision and management of medical device business enterprises, clarify the regulatory responsibilities of food and drug supervision and management departments at all levels, enhance regulatory effectiveness, and ensure public safety in the use of medical devices, this regulation is formulated in accordance with the "Regulation on the Supervision and Management of Medical Devices" and the "Measures for the Supervision and Management of Medical Device Businesses", etc. Article 2 The classified supervision and management in this regulation refers to the food and drug supervision and management departments, based on the risk level of medical devices, the business model of medical device business enterprises, the level of quality management, and compliance with regulations, combined with factors such as adverse events and product complaints of medical devices, classifying medical devices
A comparison of the various forces in China's medical device industry
2019-11-13
There are more than 15,000 medical device manufacturers and 40,000 medical device distributors in China, operating 44 major categories and hundreds of thousands of product specifications. Certain varieties have formed a regional centralized and industrialized pattern, such as Tonglu, Zhejiang; Touqiao Town, Yangzhou, Jiangsu; and Changheng, Henan. Tonglu, Zhejiang has become a distribution center for endoscopes in China, with more than 30 formally registered manufacturing companies and more than 90 trading companies. Among the larger ones are Tiansong (formerly Jianduan), Kangji, Guangdian, and Sanhe. On May 8, 2012, Shenzhen Mindray announced the acquisition of a controlling stake in Hangzhou Guangdian Medical Device Co., Ltd. Tonglu, Zhejiang
2019-11-11
On November 8, a national experience exchange meeting on medical device production quality management specifications was held in Beijing. The meeting was guided by the Medical Device Supervision and Management Department of the National Medical Products Administration and hosted by the China Medical Device Industry Association. The purpose of the meeting was to exchange advanced experiences from enterprises, leverage the exemplary role of typical enterprises, promote the overall improvement of medical device production quality management levels across the industry, and foster high-quality development of China's medical device industry. Xu Jinghe, Vice Director of the National Medical Products Administration, attended the meeting. In recent years, with the continuous advancement of medical device production quality management specifications, the medical device industry has made certain achievements in the implementation of regulations, and the overall quality and safety management of the industry has...
China's top three medical device counties
2019-11-07
China's biopharmaceutical industry is showing a trend of regional industrial diversification, giving rise to a number of regionally distinctive industrial clusters. These clusters have carved out a unique path of industrial development, focusing on specific sub-sectors as entry points and key development directions. The experience of local governments in terms of industrial positioning, policy support, and industrial services is worth learning from. With increasing support from policies and funding, China's biopharmaceutical industry is further exhibiting a trend of clustered development, with active planning and support at both the national and local levels. The three major production areas represented by the Yangtze River Delta, the Bohai Rim, and the Guangdong-Hong Kong-Macao Greater Bay Area...
Ten Major Changes in the Medical Device Circulation Field in 2019
2019-11-06
I. Nationwide Implementation of the Two-Invoice System for Consumables is Accelerating
By the end of 2018, four provinces had implemented the two-invoice system for consumables: Qinghai, Shaanxi, Anhui, and Tibet. In addition to provinces, numerous cities and counties also piloted the two-invoice system, with the Sanming Alliance as a representative example. By the end of 2018, the Sanming Alliance members covered 15 provinces and 53 cities and counties. According to the Sanming Alliance agreement, member units must implement the two-invoice system for consumables.
In addition to the provinces and cities that have already implemented the system, 17 other provinces have also clearly stated their intention to implement the two-invoice system for consumables. Among them, Fujian Province and Zhejiang Province, as advanced provinces in medical reform, are leading the nation, and Fujian...
The world's smallest medical device is this
2019-11-04
Recently, a miniature medical imaging sensor developed by OmniVision Technologies, Inc. of the United States won a Guinness World Record, being called the world's "smallest commercial image sensor." Just how small is "smallest?" So, just how small is this smallest commercial imaging device? The OV6948 is only 0.575 mm x 0.575 mm x 0.232 mm! If the numerical value of its Size still doesn't give you a concrete idea, let's take a look at the comparison between the miniature camera module it's integrated into and a grain of pepper. This should make it clear: A miniature camera next to a grain of pepper
2019-10-31
In April 2017, KaiLi Medical was listed on the ChiNext board. This medical device company, which had been established for 15 years at the time, was leveraging the innovation and vitality of the ChiNext board to焕发出新的光彩、迎来更广阔的发展空间. Tracing back to the early days of color ultrasound, it was uncommon to find manufacturers globally focusing solely on color ultrasound production. As the clinical demand for color ultrasound gradually expanded, foreign medical imaging giants, through mergers and acquisitions, concentrated core technologies and gradually established complete R&D, production, and sales platforms, initially showing signs of a monopoly. In 2002, Yao Jinzhong, from the "regular army" Shantou Ultrasound Instrument Research Institute
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