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Pilot program for medical device registration applicants in the Yangtze River Delta region announced
2019-10-30
On October 30, 2024, to promote the high-quality integrated development of the medical device industry in the Yangtze River Delta region and to further accumulate experience for the nationwide implementation of the medical device registrant system, the drug regulatory authorities of Shanghai, Jiangsu, Zhejiang, and Anhui jointly issued the Implementation Plan for the Pilot Program of the Medical Device Registrant System in the Yangtze River Delta Region (hereinafter referred to as the Plan). The Plan points out that the pilot program aims to explore the establishment of a management system for the commissioned production of medical devices, explore innovative ways to regulate medical devices, explore the release of dividends from medical device registrants, optimize resource allocation, clarify cross-regional regulatory responsibilities, and
2019-10-28
Recently, one of the sub-forums of the 4th China Pharmaceutical Regulatory Science Conference (2019) - the Medical Device Regulation Forum - was held at the Beijing Conference Center, attracting nearly 200 representatives from regulatory agencies, pharmaceutical companies, and associations. The director of the Medical Device Supervision Department of the National Medical Products Administration stated at the meeting that the revision of the "Regulations on the Supervision and Administration of Medical Devices" has entered the review stage. This revision mainly involves comprehensively strengthening the medical device registrant system, optimizing and improving the requirements for registration testing, clinical evaluation, and clinical trials, gradually implementing the medical device identification system, regulating online sales, and establishing a professional and specialized
2019-10-25
I. Overview of the Medical Device Industry Medical devices include instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials, and other similar or related articles, including the necessary software, used directly or indirectly on the human body, mainly for medical diagnosis, monitoring, and treatment. Source: Publicly available information compiled Since 2014, various provinces and cities have introduced relevant policies requiring the prioritization of domestically produced medical equipment in procurement, prohibiting the specification of imported products, and setting targeted parameters; in particular, provinces such as Zhejiang and Sichuan have essentially required that, except for certain particularly high-end equipment or high-end tertiary hospitals, domestically produced equipment must be used.
Market trends that ultrasound professionals cannot afford to miss
2019-10-24
On the afternoon of October 13th, the "2019 Medical Ultrasound Market Data Inventory" seminar, jointly organized by "Medical Recruitment and Procurement" and "Medical Device Home," was successfully held in Beijing. The seminar was hosted by Shi Yun, founder of "Medical Device Home," with Luo Shitong, CEO of Eibai Zhihui Data Consulting Co., Ltd., sharing specific data on the ultrasound market. Participants, including market and marketing managers from various medical ultrasound manufacturers and securities representatives, gathered to discuss "New Trends in the Ultrasound Market in 1H 2019," raising questions, exchanging experiences, and sparking creative thinking. Shi, founder of "Medical Device Home,"
2019-10-23
Source: CMEF China International Medical Equipment Fair. Copyright belongs to the original author. With sustained and stable economic development, increased per capita disposable income, population growth, an aging population, and increasing demand for high-level medical care, the global medical device market is booming. According to statistics, in 2014, the global medical ultrasound diagnostic equipment market reached approximately US\$6.2 billion. It is expected to reach US\$7.4 billion in 2019, with a compound annual growth rate of 3.6%. Although China's ultrasound industry started late, after years of development, it has initially formed a complete range of professional categories, a complete industrial chain, and production
Medical Device Registration: This article is all you need
2019-10-21
Registration testing is the first major step in evaluating products before they are put on the market, and it plays an important role in registration review and post-market surveillance. With the rapid development of the medical device industry, compared to the pharmaceutical management system, the registration testing of medical devices and testing institutions are still somewhat insufficient. Strengthening the supervision of medical devices, improving the quality standards and management systems, and ensuring the safety and effectiveness of medical device use are particularly important. I. Current Status of Medical Device Registration Testing Medical device registration testing is a full-performance test of the product, also known as type testing. Class II and Class III medical devices undergo registration testing by medical testing institutions accredited by the State Administration (Class I medical devices...
2019-10-18
To implement the "Notice of the General Office of the State Council on Issuing the Reform Plan for the Governance of High-Value Medical Consumables" (Guobanfa [2019] No. 37), the National Medical Products Administration (NMPA) issued the "Rules of the Unique Identification System for Medical Devices", and jointly with the National Health Commission, carried out pilot work on the unique identification system for medical devices. On October 14, the NMPA issued the "Notice on Doing a Good Job in the Relevant Matters of the First Batch of Implementation of the Unique Identification of Medical Devices" (hereinafter referred to as the "Notice"). The "Notice" clearly stipulates the scope of varieties, progress schedule, and work requirements for the first batch of medical devices with unique identification. According to the "Notice..."
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