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The National Medical Products Administration (NMPA) announces 24 medical device industry standards
2019-07-31
China Quality News Network reported on July 30 that the State Drug Administration's website announced that 24 medical device industry standards, including YY/T0506.8-2019 "Surgical drapes, gowns and clean garments for patients, medical staff and instruments Part 8: Product-specific requirements", have been approved and are now being released. Medical Device Industry Standard Information Table Serial Number Standard Number Standard Name Revision and Replacement Standards Applicable Scope Implementation Date 1 YY/T0506.8-2019 Surgical drapes, gowns and clean garments for patients, medical staff and instruments Part 8: Product-specific requirements Development This standard specifies the requirements for patient, medical staff and instrument
Eight Opportunities and Ten Trends in the Medical Device Industry!!
2019-07-30
With China's further deepening of reform and opening up, social construction, economic construction, and cultural construction have all entered a new development period. Against this broad social backdrop, public demand for medical services is gradually increasing, with the innovation and development of medical devices maintaining a rapid and healthy momentum, and regulatory policies are expected to be further improved. Over the past two years, the author has systematically studied the industry's development. By reviewing the development trajectory and achievements of China's medical device industry over the past 20 years, it is judged that the industry will Enter the fast lane in the next decade. Eight major opportunities and challenges analysis and summary of the current stage of China's medical
Third-party medical device logistics companies urgently need regulation
2019-07-26
Medical Device Third-Party Logistics: A Growing Sector Amidst Regulatory Uncertainty
The rapid growth of the medical device industry and the implementation of the "two-invoice system" for medical consumables have given rise to third-party logistics (3PL) companies specializing in medical devices. These companies provide storage and distribution services for medical device manufacturers and distributors. Their emergence aligns with the current state of the industry and the "two-invoice system" policy, making them a new and growing sector.
However, current laws and regulations lack clarity regarding the specific requirements for medical device 3PL companies. For example, what licenses or permits are required for a medical device 3PL company to operate legally? What specific software and hardware infrastructure must such companies possess?
Top 100 Medical Device Companies of 2019
2019-07-25
In the internet age, for excellent enterprises in all walks of life with lofty aspirations, doing a good job in internet work is no longer just an option, but is becoming a necessity for further strengthening and development, and has a causal relationship with the overall performance. As small as a website, as large as a strategy. Just like entering a company, if you see the receptionist drowsy, generally speaking, this company will not be very good. Conversely, any important point is a reflection of the whole, reflecting the values and vision of the highest leader of the enterprise, which conforms to the holographic law. It is believed that this correlation will become increasingly clear in the future. With the desire for a healthy life as the most important
2018 List of Innovative Enterprises in China's Medical Device Technology
2019-07-24
Zhonghui Business Intelligence Network News: Recently, supported by the All-China Federation of Industry and Commerce (ACFIC), and hosted by the ACFIC Pharmaceutical Chamber of Commerce, with the co-organization of Jinan Municipal Federation of Industry and Commerce, Jinan Municipal Health and Health Commission, Beijing Quanlian Hui Shang Pharmaceutical Technology Consulting Co., Ltd., and Shandong Provincial Pharmaceutical Chamber of Commerce, the "2018 Most Influential List of China's Pharmaceutical Industry Release Conference and the 11th China (Jinan) Pharmaceutical Industry Development Summit Forum" was successfully held in the Qilu Hall of Shangri-La Hotel, Jinan, Shandong Province, attracting great attention from the pharmaceutical industry and all sectors of society. The conference released the "2018 Top 100 Chinese Pharmaceutical Industries, Top 50 Growing Chinese Pharmaceutical Companies, and Top Chinese Pharmaceutical Wholesalers"
Overview of US and China's Medical Device Regulations
2019-07-23
In October 2017, the General Office of the CPC Central Committee and the General Office of the State Council issued the Opinions on Deepening the Reform of the Review and Approval System and Encouraging Innovation in Drugs and Medical Devices. This is another guiding document for deepening the reform of the drug and medical device review and approval system, following the Opinions of the State Council on reforming the drug and medical device review and approval system issued in August 2015. It provides greater support for scientific and technological innovation in China's drugs and medical devices, and has milestone significance for the innovative development of China's pharmaceutical industry. This article summarizes the regulatory situations of innovative medical devices in China and the United States, providing a reference for further improving China's regulatory model for innovative medical devices. First,
2019-07-23
High-end domestically produced medical devices already have the qualifications for import substitution. As of 2017, the size of China's medical device market was approximately 445 billion yuan, with an industry growth rate of 20%, far exceeding the global growth rate. The medical device sector has many sub-fields, including in-vitro diagnostics, cardiovascular, imaging, and orthopedics. In China, the proportion of domestically produced imaging equipment is approximately 20-30%, and in-vitro diagnostics is approximately 30-40%, with an overall low domestic share, leaving considerable room for import substitution. In recent years, with the rise of domestic private enterprises, products in some sub-fields can already meet clinical needs. Policies, capital, and patents
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