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70 years of national construction: The journey of medical devices
2019-09-30
Celebrating the 70th Anniversary of the Founding of the People's Republic of China 1949-2019 On October 1, 1949, the People's Republic of China was founded, marking a new stage for the long-suffering nation. China's medical and healthcare services also embarked on a new journey. After 70 years of development, the number of people covered by China's basic old-age insurance has exceeded 950 million, and the number of people covered by basic medical insurance has exceeded 1.35 billion, weaving a basic medical security network and realizing the dream of "universal medical insurance." The development of China's medical and health services in the 70 years since the founding of the People's Republic of China, especially after the reform and opening up, is inseparable from the strong support provided by information technology.
Medical device certification requirements in various countries
2019-09-29
Medical Device Standards
Serial NumberStandard CategoryStandard Name1SafetyIEC 60601-1 Standard, applicable to general medical and dental equipment IEC 61010 Standard, applicable to in-vitro diagnostic medical devices or cleaning and disinfection equipment2Electromagnetic CompatibilityIEC 60601-1-2 Electromagnetic requirements; Radioactivity (EMI) and immunity (EMS)3BiocompatibilityISO 10993-1, Biological evaluation4Risk analysisISO 14971, Risk management application5Software confirmationIEC 60601-1-4, Programmable devices6Quality systemISO 13
Capital's entry into the medical device after-sales service market: a blessing or a curse?
2019-09-27
The medical equipment after-sale service market has reached hundreds of billions, and its good development potential, unique customer stickiness, and increasingly close connection with hospital clinics are very attractive to capital markets trying to enter the medical industry. However, the special nature of this industry makes the practice of capital parties somewhat acclimatized. The purpose of capital entry is to expand the scale, seek listing, and ultimately profit and cash out. It can ignore short-term profits in order to quickly expand its scale and occupy the market, forming an industry unicorn. Its advantages are its capital scale and some government and industry contacts. However, they obviously underestimated the uniqueness of the industry. First
2019 Medtec China Showcases the Innovative Colors of Medical Devices
2019-09-27
Endoscope cables/ultrasonic diagnostic device probe cables and cable assemblies, plastic round connectors, plug-and-play self-locking plastic connectors, miniature electric slides and push rods for transmission, positioning, and motion control in small spaces... On September 25, the three-day Medtec China Exhibition and the 15th International Medical Device Design and Manufacturing Technology Exhibition opened at the Shanghai World Expo Exhibition Hall, bringing together global resources for innovative displays. Exhibits and exhibitors cover the entire industrial chain of medical device design and manufacturing. Guests gathered together, and the Medtec exhibition helped promote China's medical device industry to the world. According to China's medical devices
The State Council inspection team has entered the medical device company
2019-09-26
Pharmaceutical website September 26 news: The state severely punishes violations in multiple aspects of medical device purchasing, sales, taxation, etc. Violators will be eliminated, and the punishment will be strengthened. On September 24, the State Council's website - the System Reform Department released the "State Council Leading Group for Deepening Medical and Health System Reform Brief," which pointed out that after the issuance of the Notice on Several Opinions on Reforms in the Medical Field by the General Office of the State Council, local governments and relevant departments earnestly implemented the deployment, cooperated vigorously, and focused on the following points: First, a strict investigation was started at the source of the production link. Meanwhile, in terms of the circulation link, enterprises are encouraged to merge and reorganize, for example:
Analysis of the Development Path of Medical Device Listing Companies in China
2019-09-25
I. Current Status of Listed Medical Device Enterprises
Selection Criteria for 120 Listed Companies:
(1) The proportion of medical device sector revenue accounts for more than 50% of the company's total revenue;
(2) The proportion of "medical devices + pharmaceuticals" revenue accounts for ≥70% of the company's total revenue in 2018;
(3) The company disclosed specific data on R&D investment expenditure in 2018.
Inclusion Criteria: Companies that meet (1)(3) or (2)(3) are included. A total of 101 listed medical device companies were included, and their development status was analyzed.
1. Listed medical device companies are relatively small in scale and lack industry leaders
2018 1
FDA Releases Draft Guidance for Medical Device Company Inspections!
2019-09-24
On March 28, the U.S. Food and Drug Administration (FDA) released a draft guidance for inspecting medical device companies, aiming to implement unified inspection processes and standards for domestic and foreign medical device companies. The FDA updated the processes and standards for inspecting medical device companies (excluding for-cause inspections) to ensure consistency and established standard timeframes for such inspections. The FDA stated, "A consistent approach to FDA inspections provides information to help firms prepare and sets basic communication and time expectations for both parties." It also identified the FD
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