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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..."
2019-10-17
Shenzhen Economic Daily, October 17, 2019. Yesterday, the Shenzhen Testing Laboratory of Guangdong Provincial Medical Device Quality Supervision and Inspection Institute held an unveiling ceremony in Pingshan District. Luo Wen, Director of the Standing Committee of Shenzhen Municipal People's Congress, and Yan Zhen, Vice Director of Guangdong Provincial Drug Supervision and Administration Bureau, attended the event. The Shenzhen Testing Laboratory of Guangdong Provincial Medical Device Quality Supervision and Inspection Institute was officially established in 2008, and has passed the national laboratory accreditation. It mainly focuses on the inspection of active medical devices. After more than 10 years of testing technology accumulation, the Shenzhen Testing Laboratory has gradually developed into an important technical testing institution for the Shenzhen medical device industry. In order to further integrate the technical advantages of Guangdong Medical Device Institute and Pingshan
World Standards Day | China's medical device standards have over 90% international consistency
2019-10-15
October 14th each year is World Standards Day, also the anniversary of the founding of the International Organization for Standardization (ISO). On October 14, 1946, representatives from 25 countries gathered in London to create a new international organization, ISO, "to promote international coordination and unification of industrial standards" (ISO officially began operations in 1947). World Standards Day We live in a world of standards; life is inseparable from standards. International Electrotechnical Commission (IEC), International Organization for Standardization (ISO), and International Telecommunication Union
The China International Medical Equipment (Autumn) Expo opened in Qingdao on the 19th.
2019-10-14
In recent years, with the strategic advancement of "Made in China" and the improvement of independent innovation capabilities, the pattern of China's medical device market has changed from being dominated by foreign companies to a situation where foreign and domestic companies are competing fiercely. This year, the medical device market has seen frequent mergers and acquisitions, and new technologies and innovative products continue to emerge. According to the China Pharmaceutical Industry Information Center's prediction: In 2019, the domestic medical device market size is expected to exceed 600 billion yuan, maintaining a rapid growth trend. More than half of 2019 has passed. What are the industry trends for the upcoming 2020? How should enterprises set their direction and position themselves in advance? The last medical device industry event of 2019
2019-10-12
Recently, the state has successively issued a number of new policies on medical devices, aiming to promote the rapid development of the medical device industry, improve and stabilize the quality of medical device products, effectively prevent and control product risks, and promote the effective implementation of product market access. At present, China's medical device regulatory system has become increasingly perfect, and the gap with developed countries has narrowed considerably. Each country has different requirements for the regulation and market entry of medical devices. If you want to export to foreign countries, you must comply with the national medical product access regulations of the importing country. Today, we will take the United States, the European Union, and China as examples to understand the management models of different countries.
Three Factors Resonate: Domestic Medical Devices Embark on a Path of High-Quality Development
2019-10-11
The 70th anniversary has passed. In this new era, various industries in China have embarked on a new journey of high-quality development. As a crucial industry related to people's livelihood and national development, the medical device industry, full of vigor and vitality, is on the path of high-quality development, driven by the combined effects of market, technological, and policy advantages. According to EvaluateMedTech, the global medical device market was approximately $405 billion in 2017, with an average annual growth of 5.6% between 2017 and 2024. The global market size is expected to be approximately $4...
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