According to ISO’s official website news show, after a period of two months after the vote, ISO 13485 international final draft (FDIS) standard has been overwhelmingly approved, ISO 13485 latest version will also be released the first quarter of 2016, which will have medical equipment industry quality management have a significant impact, SGS remind medical device companies should focus on!
ISO 13485 stands for “Medical Devices – Quality management systems – Requirements for regulatory purposes”, the standard by the ISO / TC 210- medical device quality management and general requirements for standardization Technical Committee, has released the 1996 version and the 2003 version for implementation of international, European and national laws and regulatory requirements of medical product manufacturers and service providers, and hope that the implementation of this standard document management system of the enterprise; development, manufacture and sale of medical equipment business, and want the international, European and competition on the domestic market and to demonstrate its performance capabilities of enterprises. As we all know, medical equipment in a hospital or medical center requires the use of a high-quality, standards-compliant. But for manufacturers, the risk is significant. International Organization for Standardization (ISO) has developed a number of areas covered by more than 17,000 international standards for medical devices in terms of organization, the most important of these standards is ISO 13485: 2003, which provides relevant internationally recognized Quality Management System (QMS ) guidelines. Despite the adoption of ISO 13485 certification, it may not be able to fully comply with all the requirements, such as the State Food and Drug Administration SFDA, the US Food and Drug Administration FDA and other regulatory agencies, but it is related to the quality system to meet the regulatory body established to provide systematic protection, and we can provide the commitment to maintain the effectiveness of the quality management system to customers. In line with ISO 13485 enables manufacturers to clearly demonstrate its ability to provide consistently meet customer requirements and applicable regulatory requirements for medical devices, to provide confidence for consumers and professionals.
SGS in the Port Medical Device manager, said with respect to the ISO 13485: 2003 (hereinafter referred to as the 03 version), ISO / FDIS 13485 (hereinafter referred to as FDIS Version) indeed undergone major changes. For example, the 03 version of “regulations” appears nine times, while the FDIS version appeared in up to 37 times; in the “Terms 3 Definitions”, a total of 03 Version 8 definitions, the revised version of the FDIS , including the new “clinical evaluation”, including 14 definitions, eight previously defined also modify and cut into four, and so on. Changes in the standard version of the old and new two so enormous, so the final version is released, we all wait and see, recommends that companies can get actively communicate with the third party in advance about the new points and change direction as soon as possible in response to the version ready.

SGS as a medical device and in vitro diagnostics industry leading testing and certification service provider, it has established a network of experts and medical device testing laboratory constructed in more than 35 countries. Since knowledge of local regulations and markets, and timely connection SGS global network, SGS can provide customers with a covering testing and certification, market access, third party audit, one-stop service evaluation system. In China, SGS network of services throughout the medical device key provinces and cities in Jiangsu, Guangdong, Beijing, Zhejiang, Shanghai and Shandong and other places are equipped with branch offices, to ensure the needs of enterprises can respond quickly, while, SGS professional medical device expert technical team to carry out the entire review process for enterprises to control, help you quickly get medical equipment market access.