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      The full name of the ISO13485:2003 standard is "Medical device-Quality management system-requirements for regulatory"
      The standard is formulated by SCA/TC221 Technical Committee for Standardization of Medical Device Quality Management and General Requirements, and is an independent standard based on ISO9001:2000. The standard specifies the quality management system requirements for relevant organizations, but is not a guide to the implementation of the ISO9001 standard in the medical device industry.
      The standard has been widely implemented and applied all over the world since its release in 1996. The new VERSION of ISO13485 standard was officially released on July 3, 2003. Different from ISO9001:2000 standard, ISO13485:2003 is applicable to the management standard of the regulatory environment: from the name is clearly used for the quality management system requirements of the regulations. In the international market, medical devices are not only general listed commodities operating in the commercial environment, but also subject to the supervision and management of national and regional laws and regulations, such as the FDA of the United States, THE MDD of the European Union (European Union Medical Device Directive), and the Regulations on the Supervision and Management of Medical Devices of China.
      Therefore, the standard must be legally bound and operated in a regulatory environment. At the same time, the risk of medical device products must be fully considered and risk management should be carried out in the whole process of realizing medical device products. So in addition to special requirements, it can be said that ISO13485 is actually ISO9001 in the medical device regulatory environment.
      The United States, Canada and Europe generally take ISO 9001, EN 46001 or ISO 13485 as the requirements of quality assurance system, the establishment of medical device quality assurance system is based on these standards. Medical devices should comply with the corresponding regulatory requirements before entering the market of different countries in North America, Europe or Asia.

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