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2019-08-29
According to the National Medical Products Administration (NMPA) website, 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), standardize the construction of the medical device unique identification system, and strengthen the whole life cycle management of medical devices, in accordance with the "Regulations on the Supervision and Administration of Medical Devices", the NMPA has formulated the "Rules of the Medical Device Unique Identification System", which is hereby released and shall come into effect on October 1, 2019. Article 1 of the Rules of the Medical Device Unique Identification System states that to standardize the construction of the medical device unique identification system and strengthen the whole life cycle management of medical devices, according to the "Regulations on the Supervision and Administration of Medical Devices..."
2019-08-28
Medical Device Quality Spot-Check and Inspection Management Measures (Draft for Comments)
2019-08-27
In recent years, driven by national medical reform policies and a growing public demand for high-quality medical care, the domestic medical device market has seen significant growth. Data shows that from 2008 to the present, the domestic medical device research and manufacturing sector has achieved a compound annual growth rate of over 20%. High demand has driven an overall improvement in the technological level of domestic medical devices. In the international market, long dominated by developed countries in Europe and America, Chinese leading medical device companies such as Mindray and Lepu Medical have emerged. For example, in the field of high-end ultrasound and radiology diagnostic technologies and products, Chinese medical companies are now competing with GE, Siemens, and Philips.
2019-08-26
Suzhou, August 22, 2019 /PRNewswire/ -- The China Medical Device Innovation and Entrepreneurship Competition is a national event in the medical device field initiated and advocated by the Department of Social Development Science and Technology of the Ministry of Science and Technology of China, and jointly guided and approved by the Department of Social Development Science and Technology and the China Center for Biotechnology Development. Its main purpose is to stimulate the innovation vitality of enterprises and scientific researchers, strengthen the connection between innovation and clinical application and capital, deepen the cooperation among various aspects of the medical device industry, including "production, education, research, application, and supervision", and thus promote the sustainable innovation and development of China's medical device industry. The China Medical Device Innovation and Entrepreneurship Competition was first held in 2018, with a total of 283 innovative medical device projects under research.
Medical device unique identification database nationwide announcement, maximum transparency!
2019-08-23
Unique Device Identification (UDI) is the electronic identity card for medical devices. In the context of the information age, UDI is an advanced means of international medical device regulation, a "universal language" for global traceability of medical devices, signifying that medical devices can be traced and monitored throughout their entire lifecycle, from production and processing to circulation, distribution, and use! On August 9, 2019, the National Medical Products Administration issued a "Notice on the Pilot Program Training for the Unique Identification System of Medical Devices" (hereinafter referred to as the "Notice").
2019-08-23
A series of national-level measures to govern high-value medical consumables have, in addition to squeezing out the "water" in their inflated prices, also created a prime opportunity for manufacturers of high-value medical consumables with truly independent intellectual property rights and core competitiveness to stand out. In the long run, volume-based procurement in the field of high-value medical consumables is expected to accelerate the substitution of domestic products for imported ones. Foreword In recent years, thanks to China's economic development, the increasing demand for people's health, significant improvements in R&D and manufacturing capabilities, and policy benefits such as national support for innovation in domestic medical devices and encouragement of domestic substitution of imports, China has...
2019-08-22
Currently, the innovation capabilities of medical device enterprises in our country are relatively weak. High-end products on the market are more often seen from multinational corporations. Compared to these large companies, our enterprises, doctors, and scientists are still somewhat lacking in innovation capabilities, and product research and development registration is more difficult for us. I believe that an important reason for this result is the difference in innovative thinking. In the process of product research and development, functionality research and development comes first. Next, it needs to undergo tests of compliance, reliability, ease of use, and mass production. The first is compliance; there are more than 1600 national and industry standards for medical devices, and innovation is frequent
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