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ISO13485 Medical device-Quality management system-requirements for regulatory

      ISO 13485:2003 standard is a completely independent standard specially used in medical equipment industry, based on the ISO 9001 “Quality management system requirements” as the foundation, adopts the quality management concept of ISO 9000, refers to the structure terms and format of the ISO 9001, and contains most general requirements of “Quality management system”, to ensure that the medical device manufacturing enterprise establish and maintain quality management system, and has a steady production ability of the medical devices within the specified requirements.
  ISO 13485: 2003 is based on medical device regulations as the main line, emphasizes the importance of implementing the medical device regulations, and puts forward the related medical devices regulations, through satisfying the medical device regulatory requirements, to ensure the medical instruments’ safety and effectiveness, and is a great breakthrough of GHTF coordinating among governments in recent years, reflects the principle that medical quality management system construction of production enterprises must focus on safety and effectiveness, many of the requirements of this principle are to be reflected by the government laws and regulations, and prescribed in the laws and regulations of government.
  Quality management system of medical equipment production enterprise, must implement the relevant laws and regulations at the same time, this is the difference between the implementation of basic medical equipment quality management system certification and other industries. ISO 13485:2003 standard is to promote the coordination of the world medical device regulations, promote the consistent of world diverse medical administrative regulation and technical regulations, and contribute to the consistency requirements of the medical devices regulations, conform to the trend of economic globalization, promote the international trade development and progress of medical devices.
  The ISO13485 standard is the basic standard of medical equipment production and quality management, applies to the key factor of the whole process of medical equipment preparation production which affecting the quality of the finished product in production process. It can strengthens the management of medical equipment and enterprise quality control, ensure the personal safety of patients; provides the user with stable quality of the product can enhance and improve enterprise management level, and increases the visibility of the enterprise; improve and guarantee the quality of products, make the enterprise to obtain greater economic benefits; it’s advantageous to eliminate the trade barriers, and obtains the passport to enter the international market; it’s advantageous to strengthen the competitiveness of the products, improve the product's market share.
  The publication of 2003 edition of ISO 13485 provides an important premise and opportunities to promote the level of China's medical equipment production quality management. Using the experience of other countries for reference, base the practice in the United States and some European countries to promote the medical device production quality management standard work. The implementation of the 2003 edition of ISO 13485 is conducive to put China's medical device manufacturing enterprise management level and product quality on a new stage , ensure the safety of medical equipment effectively, deepen the supervision and administration of medical devices, promote the development of the medical equipment quality certification, and is conducive to the healthy and rapid development of China's medical equipment industry.
  After the release of ISO 13485:2003 standard in 2003 July by ISO, the State Food and drug administration apply the equivalent principles transform it into a industry standard YY/T 0287 - 2003 "quality management system for medical equipment regulations" in September 17, 2003, Medical equipment manufacturing enterprises, trading enterprises, regulatory authorities, medical equipment medical equipment certification bodies, inspection institutions, medical use of departments and related units are studying and implementing the ISO 13485:2003 standard, to improve the overall level of China's medical equipment industry.
  Medical equipment is an important foundation for the construction of medical health system which has highly strategic, driven and growth, its strategic position has been paid attention to by the countries all over the world, and has become an important symbol of a national science and technology progress and the national economy modernization level. Medical devices as special products to heal the wounded and rescue the dying, to prevent and cure diseases, its product quality is directly related to the personal health, its security and effectiveness have higher and higher requirements. Therefore, countries will be based on the safety of medical devices and the potential harm may have to the human body to classify and manage medical devices, and carry out strict quality certification system at the same time.
  According to China's Health Insurance Association data, China's import and export of medical devices involving a total of 47 categories, 5000 species, more than 30,000 specifications of medical products, has become a major global medical device produce and export base. In 2011, the total import and export of medical equipment amounted to $ 26.598 billion, an increase of 54.43%. Among them, exports of $15.711 billion, an increase of 53.62%; imports amounted to $10.887 billion, an increase of 55.62%. In 2011, the main export region of China's medical device products is still Asia, Europe and North America. United States, Germany and Japan, the three traditional top three import market continues to grow. The growth of China's exports to Russia, India and the Philippines and other emerging markets is significant. As China's medical device product quality continues to improve, and the enterprises’ deep understanding of the relevant policies and regulations of access to international markets, enterprises with new medical devices of high technical content, easy to use, safe and effective will have a strong competitiveness.
  Along with the ISO 13485:2003 being actively promoted in our country's medical enterprise management and actively developed in international market, these export-oriented enterprises are badly in need of the ISO 13485: 2003 management system certification, in order to make their products to successfully enter the target market. Carrying out ISO 13485: 2003 certification for foreign trade enterprises actively can not only help enterprises to become bigger and stronger in the market, and can form effective good interaction with this type of enterprises in the exploration and practice of ISO13485 management system, it plays a good role in promoting the development of the national economy and improving the level of the corresponding management.