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Analysis of the Current Status of Personalized Medical Device Technology Review and Regulation
2019-08-21
Meeting Personalized Needs: Focusing on Customization In recent years, additive manufacturing technology has developed rapidly, and its characteristics of precise processing, low cost, high degree of automation, and customizable production have gradually become apparent. Unlike the mass-produced nature of subtractive manufacturing technology, customized production perfectly matches the needs of precision medicine in the medical field. Domestic and international industries are increasingly calling for the use of personalized medical devices to replace existing standardized products, which has gradually become a consensus in the medical community. In the face of this situation, both domestic and international regulatory authorities and academia have conducted explorations and reflections. The U.S. FDA has issued guidelines on personalized additive manufacturing medical devices, and Europe has also conducted relevant
2019-08-19
At the "Healthy China Construction in the 5G Era" summit forum, Jiang Deyuan, an inspector from the Medical Device Registration Office of the National Medical Products Administration, revealed that the "Medical Device Supervision and Administration Regulations" is expected to be promulgated this year. In recent years, the five tasks of the Medical Device Registration Office of the National Medical Products Administration in continuously optimizing its operation mechanism are: First, the issuance of the "Decision on Adjusting the Approval Procedures for Certain Medical Device Administrative Approval Matters", which centralizes the approval procedures for continued registration and registration changes to the Medical Device Review and Evaluation Center, reducing the number of steps and improving efficiency. Second, the revision of the "Catalog of Medical Devices Exempt from Clinical Trials". So far, there are 1
Top 100 Global Medical Device Companies (with Sub-segment Rankings)
2019-08-19
Because medical device companies have different fiscal year ends, some companies don't end until July of the following year, so the complete list comes out relatively late. Tonight, Dami will share Informa's MTI100 list with everyone. This list is ranked according to the revenue of each company in fiscal year 2017. Because fiscal year ends vary, some company revenue data is as of July 2018. In addition, for some diversified group companies, only medical-related businesses (medical devices, IVD) are included. According to Informa's data, the total sales of the top ten medical device companies in this statistical period exceeded US\$157 billion globally.
A clear path for the innovative development of customized medical devices
2019-08-15
Recently, the National Medical Products Administration and the National Health Commission jointly issued the "Regulations on the Supervision and Administration of Customized Medical Devices (Trial)" (hereinafter referred to as the "Regulations"), which officially came into effect on January 1, 2020. As the first regulation to unify the supervision of customized medical devices, the "Regulations" clearly stipulates requirements for the filing management, design and processing, use management, and supervision and administration of customized medical devices. Industry experts believe that the promulgation of the "Regulations" will allow customized medical devices to be used in a standardized manner in clinical practice, which is conducive to ensuring the safety of patients' use of medical devices. I. Meeting Clinical Needs The so-called customized medical devices refer to those designed to meet the specific needs of a particular patient.
2019-08-14
I. Analysis of the Scale of Development of the Chinese Medical Device Market In 2018, the scale of China's medical device market reached 530.4 billion yuan, a year-on-year increase of 19.9%, maintaining a growth rate of nearly 20% for consecutive years. From the perspective of sub-sector distribution, in 2018, the medical equipment market reached 301.3 billion yuan, the highest proportion. The high-value consumables market (orthopedic implants, vascular intervention, neurosurgery, etc.) reached 104.6 billion yuan, the low-value medical consumables market reached 64.1 billion yuan, and the in-vitro diagnostics market reached 60.4 billion yuan. In terms of sub-sector growth rate, high-value consumables grew by 20.4% in 2018, including vascular intervention and dentistry.
Current Status: Opportunities and Challenges Facing China's Medical Device Industry
2019-08-13
When people fall ill, doctors often use various assistive tools to diagnose, treat, monitor, alleviate, and prevent related symptoms. These assistive tools are generally referred to as medical devices. Medical devices refer to instruments, equipment, appliances, in-vitro diagnostic reagents and calibrators, materials, and other similar or related articles used directly or indirectly on the human body, including the necessary computer software. The efficacy of medical devices is not obtained through pharmacological, immunological, or metabolic means, but primarily through physical means. Medical devices are diverse, with significant differences between products.
Medical Device Top 8 Competition: Medtronic Leads the M&A Marathon
2019-08-12
EvaluateMedTech predicts that the global medical device market will reach $477.5 billion in 2020. Although this market is lucrative, it is undeniable that the global medical device market is currently dominated by several large international companies. In mid-2019, major medical device companies released their 2018/2019 fiscal year reports. Based on this, we have compiled a list of the top 8 medical device companies from the MedicalDesign&Outsourcing Top 100 list.
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