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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 Analysis of China's Medical Device Market: Strong Market Demand, Qualified for Import Substitution

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

New regulations for medical device supervision and administration will be released

2019-07-22

During the China Pharmaceutical Innovation Development Conference, Jiao Hong, director of the National Medical Products Administration, stated: "We will actively promote the release of the newly revised "Drug Administration Law" and "Medical Device Supervision and Administration Regulations" within the year, accelerate the revision of supporting regulations, provide legal and regulatory safeguards for the early implementation of various reform measures, and release policy dividends." The China Pharmaceutical Innovation Development Conference recently opened in Jinan, with Jiao Hong, director of the National Medical Products Administration, in attendance and giving a speech. Jiao Hong pointed out that after 40 years of reform and opening up, China's public drug use has been basically met, the level of drug security has continued to improve, and China has actively contributed to the world. Currently, domestic medical

The National Health Commission continues to issue documents supporting the accelerated entry of domestic medical equipment into hospitals!

2019-07-19

The National Health Commission has issued consecutive documents in support of the comprehensive promotion of the priority use of domestically produced medical equipment in the medical industry! The Ningxia Hui Autonomous Region Health Commission's official website published the "Notice of the Autonomous Region Health and Health Commission Office on Further Regulating the Procurement of Imported Medical Equipment and Reagents and Consumables". This Notice is the first document issued by the Health Commission since the beginning of this year regarding the strict restriction of imported medical equipment! The Notice clearly states that government procurement should procure domestic products; for those that require the procurement of imported products, an examination and approval system will be implemented! In terms of the review of the "Government Procurement of Imported Products Expert Review Opinion Form" issued by the expert group, the Notice specifies the qualifications of the experts
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