Search Results for “medical device” – media

【EXPERT Q&A】How to determine the clinical evaluation path of medical devices?

Drugdu.com expert’s response: The clinical evaluation pathway for medical devices is a crucial process for assessing their safety and effectiveness, determining their suitability for market release and clinical use. Below are the general steps and considerations for determining the clinical evaluation pathway for medical devices: Ⅰ. General Steps Clarify Product Characteristics and Scope of Application: Understand the basic principles, structural composition, manufacturing materials, and intended use of the medical device. First, confirm the scope of application of the product to facilitate targeted clinical evaluation. Assess Clinical Risks and Existing Clinical Data: Analyze potential adverse events or risks associated with the product during use. Evaluate whether sufficient clinical data exist to support the safety and effectiveness of the product. Select Clinical Evaluation Pathway: Based on product characteristics, clinical risks, and existing clinical data, select the most suitable clinical evaluation pathway. Ⅱ. Considerations Inclusion in the “Catalogue of Medical Devices Exempt from ...
- Source: drugdu
- 29
- November 20, 2024
Two innovative medical devices were approved for marketing

Recently, the National Medical Products Administration announced the approval of two innovative product registration applications: “Brain Surgery Planning Software” by Beijing Huake Precision Medical Technology Co., Ltd. (hereinafter referred to as Huake Precision) and “Implantable Deep Brain Neurostimulation Extension Lead” by Boston Scientific Neuromodulation Company (hereinafter referred to as Boston Scientific). Huake Precision focuses on the research and development, production and technical services of intelligent and innovative medical devices. It is a leading company in China’s innovative neurosurgery medical devices, providing comprehensive technology and product solutions for the treatment of brain diseases. It is reported that Huake Precision currently has five major product lines including the SR series of neurosurgery robots, the Q300 series of micro neurosurgery robots, the NS series of neurosurgery navigation, the Huake Hengsheng intracranial electrode series, and the LS series of magnetic resonance guided laser ablation treatment systems. It has built a full-chain technology system including ...
- Source: drugdu
- 46
- November 14, 2024
【EXPERT Q&A】What is a Certificate of Free Sale of medical Devices?

Drugdu.com expert’s response: Medical Device Free Sale Certificate (FSC): Definitions, Roles, Differences from Registration Certificates, and Application Process Ⅰ. Definition A Medical Device Free Sale Certificate (FSC) is a document issued by the competent authority or certification body in the country or region where the medical device manufacturer or supplier is located. It serves as proof that a specific medical device is legally and freely sold in its country of origin or region, and complies with the corresponding regulations and standards. Ⅱ. Roles Proof of Compliance: This certificate demonstrates that the medical device has passed the review and approval of the regulatory agency in the country of origin or region, and complies with local regulations and standards. Support for International Trade: The Medical Device Free Sale Certificate is often used to support international trade in medical devices, especially when entering certain countries or regional markets, proving that the product meets ...
- Source: drugdu
- 49
- November 11, 2024
Two innovative medical devices have been approved for market launch

Recently, the National Medical Products Administration announced the approval of the registration applications for two innovative products, Yabonixi Medical Technology (Suzhou) Co., Ltd.’s “knee joint prosthesis system” and Shanghai Xinwei Medical Technology Co., Ltd.’s “intracranial aneurysm embolization assisted stent”. Yabonixi Medical offers freedom of movement in all aspects Yabonixi Medical is a wholly-owned subsidiary of Jiaoying Medical Equipment (Shanghai) Co., Ltd., dedicated to the research, development, production, and sales of high-end orthopedic medical equipment, minimally invasive surgical medical equipment, and more. Yabonixi Medical was founded by Dr. Yao Jianqing, a leading figure in the international orthopedic field. It is reported that Yao Jianqing is an experienced veteran in the field of medical devices, with 36 years of rich experience in medical device and tissue engineering research and industrialization. He has served as the Global R&D Senior Director and Asia Pacific R&D Senior Director of ZimmerBiomet, a joint company. Yao Jianqing ...
- Source: drugdu
- 57
- November 6, 2024
【EXPERT Q&A】What are medical device quality management system nonconformities?

Drugdu.com expert’s response: Non-conformities in the quality management system for medical devices refer to situations where an activity or its outcome in the quality management system activities related to medical device production, sales, and after-sales service fails to meet established requirements or standards. These requirements or standards typically originate from relevant regulations, standards, contracts, and internal quality management system documents of the enterprise. Non-conformities can manifest in various forms, including but not limited to non-conformities related to documents, products, processes, personnel, environments, records, and data. Specifically, non-conformities in the quality management system for medical devices may involve the following aspects: Document Non-conformity: Quality management system documents do not comply with applicable laws, regulations, standards, or contracts. For instance, there may be no documented corrective action control procedure established, no clear review of nonconformities (including customer complaints), no determination of the causes of nonconformities, no evaluation of measures needed to ensure ...
- Source: drugdu
- 60
- November 6, 2024
Medtronic’s’ 2 Medical Devices’ Approved for Market by FDA

Recently, Medtronic announced that its Affera radiofrequency ablation system and Sphere-9 catheter have been approved for market by the US Food and Drug Administration (FDA). It is understood that this is an integrated electrophysiological product capable of pulsed field ablation (PFA) and radiofrequency (RF) ablation, approved for the treatment of persistent atrial fibrillation (AFib) and tricuspid isthmus dependent atrial flutter, and previously obtained CE marking approval in March 2023. Innovative products demonstrate differentiation advantages The two medical devices approved this time originated from Affera, which Medtronic acquired for $1 billion in August 2022 and introduced these technologies. The competition in the field of electrophysiology is fierce, and Medtronic has further solidified its position with these two medical devices. The Affera radiofrequency ablation system is an integrated high-resolution mapping and treatment solution that provides more predictable and flexible surgery, allowing doctors to accurately map and ablate using radiofrequency and electrical pulse ...
- Source: drugdu
- 69
- October 30, 2024
Six major centers of the National Medical Products Administration “gathered”, and the review and approval of medical devices were fully upgraded

On October 23, with the establishment of the National Medical Products Administration Information Center in Beijing Medical Innovation Park BioPark, the six major centers of the National Medical Products Administration have been “assembled”. The six centers are the Drug Review Center of the National Medical Products Administration’s directly affiliated units, the Food and Drug Review and Inspection Center, the Drug Evaluation Center (National Drug Adverse Reaction Monitoring Center), the Medical Device Technical Review Center, the Administrative Affairs Acceptance Service and Complaint Reporting Center, and the Information Center (China Food and Drug Regulatory Data Center). Beijing Yizhuang gathers regulatory resources to provide strong guarantees for the high-quality development of biotechnology and the big health industry in terms of enterprise industry administrative approval, qualification certification, etc. In the National Bureau’s administrative affairs acceptance service hall, 10 windows are neatly arranged to handle the acceptance, consultation, charging, and certification of administrative licensing matters ...
- Source: drugdu
- 49
- October 29, 2024
Medical device giant welcomes new head of China region

On October 21st, Omron Health Medical (China) Co., Ltd. (hereinafter referred to as Omron Health Medical) officially announced the appointment of Chen Xixiao as the Managing Director. After taking office, Chen Xiaoxiao will be fully responsible for the business development and strategic planning of Omron’s healthcare business in China, deepening Omron’s strategic layout in China, continuously enhancing the brand’s influence in the Chinese market, and solidly moving towards the beautiful vision of “Going for ZERO Preventive Medicine, Making the World Healthier”. The new helmsman takes office Omron Group was founded in 1933 by Lishi Yizhen and is a globally renowned manufacturer of automation control and electronic equipment, with expertise in sensing and control core technologies. By continuously creating new social demands, Omron Group has over 28000 employees worldwide and a turnover of 818.8 billion yen. The products cover a wide range of fields such as industrial automation control systems, electronic ...
- Source: drugdu
- 65
- October 25, 2024
Boston Scientific’s’ 2 Medical Devices’ Approved for Market by FDA

On October 21st, according to foreign media Fierce Biotech, the FARAWAVE NAV ablation catheter and Faraview software integrated with Boston Scientific’s navigation function have been approved by the US Food and Drug Administration (FDA). It is reported that the above two products have been officially launched in the United States, forming part of the Boston Scientific Farapulse Pulsed Field Ablation (PFA) system, providing a new visualization solution for cardiac ablation surgery. New features added The FARAWAVE NAV ablation catheter is an upgrade based on the previous generation PFA product FARAPULSE. It looks very similar to the FARAPULSE ablation catheter in appearance, but the new generation product has many new features that were not present in the previous generation product – magnetic navigation function and equipped with a dedicated 3D FARAVIEW module (software). Therefore, this also enables the FARAWAVE NAV ablation catheter to have both ablation and mapping functions:  Ablation ...
- Source: drugdu
- 81
- October 24, 2024
Going overseas in the storm of price cuts

This year, “going overseas” is still a hot keyword in the medical device industry. Especially at present, the domestic medical device market has entered a plateau period, and local “roll kings” are increasingly aware of the importance of going overseas. A positive signal is that the recognition of Chinese medical devices in overseas markets is constantly rising. At the just-concluded CMEF Autumn Exhibition, participants could clearly feel that international friends have become more enthusiastic about the Chinese medical device exhibition. According to the organizer, the number of pre-registrations for international visitors at this year’s exhibition exceeded twice that of the same period last year. On the background walls of the booths of some local exhibitors, large-scale introductions to companies and products and services are printed in English, which can be said to have spared no effort in attracting overseas attention. The cost advantages of Chinese medical devices and the product ...
- Source: drugdu
- 62
- October 24, 2024

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