ISO13485 certification standard is dedicated to the medical device industry is a completely independent standard, is based on ISO9001 "quality management system requirements" standards. ISO13485 certification standards are based on medical equipment regulations as the main line, emphasizing the importance of the implementation of medical equipment regulations, the relevant medical equipment regulatory requirements, by meeting the requirements of medical equipment regulations to ensure the safety and effectiveness of medical equipment, ISO13485 certification in recent years GHTF A major breakthrough in coordination among governments has reflected the principle that the quality management system of medical device manufacturers must be built around the essence of safety and effectiveness. Many of the requirements of this principle are embodied in government laws and regulations. Into the government's laws and regulations. ISO13485 certification standards to promote the world's medical equipment regulatory standards as the goal.

ISO13485 certified content

ISO13485 certification standards for medical equipment production and quality management of the basic criteria for the production of medical equipment in the production process of the whole process of affecting the quality of the key processes. It can strengthen the management of medical equipment, strengthen enterprise quality control, to ensure the safety of patients; to provide users with stable quality products can improve and improve the management level of enterprises, increase the visibility of enterprises; improve and ensure the quality of products, so that enterprises To obtain greater economic benefits; is conducive to the elimination of trade barriers, access to the international market pass; is conducive to enhancing the competitiveness of products, improve product market share.

2003 version of the ISO13485 certification standards for the promotion of China's medical equipment production quality management level provides an important prerequisite and opportunities. Learn from the experience of the US FDA, according to the United States and some European countries to promote the practice of medical equipment production quality management norms. 2003 version of the implementation of ISO13485 is conducive to the management of medical equipment manufacturing enterprises in China and the physical quality of a new level, is conducive to ensuring the safety and effective medical devices, medical equipment is conducive to the supervision and management of deepening, is conducive to medical equipment quality certification business Development, is conducive to the healthy and rapid development of China's medical equipment industry.

ISO in July 2003 after the release of ISO13485: 2003 standards, the State Food and Drug Administration in accordance with the principle of the same principle in September 17, 2003 into the industry standard YY / T0287-2003 "medical device quality management system for regulatory The use of medical equipment, enterprises, business enterprises, medical equipment regulatory authorities, medical equipment certification bodies, testing organizations, medical equipment use departments and related units are studying and implementing ISO13485: 2003 standards, and effectively improve the overall level of China's medical equipment industry.

ISO13485 certification role

Medical equipment is an important foundation of the construction of medical and health system, with a high degree of strategic, driven and growing, its strategic position has been the world's attention, has become a national scientific and technological progress and national economic modernization of the important symbol. Medical equipment as a life-saving, disease prevention and treatment of special products, its product quality is directly related to the health and safety of the person, its safety, effectiveness has also been higher and higher requirements. Therefore, countries will be based on the safety of medical devices and the human body may have the potential harm to the medical device products for classification control and management, while its strict quality certification system.

According to the China Medical Insurance Chamber of Commerce data show that at present, China's medical equipment import and export involving a total of 47 categories, 5,000 varieties, more than 30,000 specifications of medical equipment products, has become the world's major medical equipment production and import and export base. In 2011, China's total imports and exports of medical equipment amounted to 26.598 billion US dollars, an increase of 54.43%. Among them, exports amounted to 15.711 billion US dollars, an increase of 53.62%; imports amounted to 10.887 billion US dollars, an increase of 55.62%. 2011 China's medical equipment exports are still the main geographical areas of Asia, Europe and North America. The top three of the United States, Germany and Japan, the three major traditional market imports continued to grow. China's exports to emerging markets such as Russia, India and the Philippines are growing significantly. With the continuous improvement of the quality of medical equipment products in China, as well as enterprises on the international market access to relevant policies and regulations in-depth understanding of China's more and more medical device products into a number of market access threshold is higher, more competitive areas , With high technological content, easy to use, more safe and effective new medical equipment for the support of enterprises will have a strong competitive edge.

With the active implementation of ISO13485: 2003 and the international market, these export-oriented export enterprises need to pass ISO13485: 2003 management system certification, so that its products successfully enter its target market. Actively carry out the ISO13485: 2003 certification of foreign trade enterprises, not only can help enterprises in the market bigger and stronger, and with such enterprises in the ISO13485 management system to explore and practice the formation of effective and effective interaction, regardless of the national economy Development and the corresponding level of management have played a good role in promoting.