The new ISO medical equipment regulations came into effect on May 1, and CFDA introduced international standards

Source: on May 1, 2017, the standard of YY / t0287-2017 / iso13485:2016 quality management system of medical devices for regulatory purposes approved by CFDA was officially implemented CFDA introduced the ISO international standard CFDA to indicate that YY / t0287-2017 medical device quality management system requirements for regulations (hereinafter referred to as the new version of the standard) is equivalent to the iso13485:2016 standard ISO13485 standard is a quality management system standard applied in the field of medical devices, focusing on the safety and effectiveness of medical devices, emphasizing that the medical devices provided by the organization should meet the requirements of customers and regulations According to the international organization for Standardization (ISO), iso13485:2016 further emphasizes the importance and necessity of implementing regulations and requirements, and improves the compatibility of regulations and standards It also clarifies that the standards of quality management system are applicable to medical device organizations in all stages of the whole life cycle industry chain of medical devices, and further ensures all stages of the whole life cycle of medical devices The safety and effectiveness of the segment; strengthened new requirements based on risk analysis and risk management; put forward new requirements for the supply chain and procurement of medical devices; and supplemented new requirements for post market supervision and improvement of medical devices In addition, the standard is applicable to all kinds of organizations involved in the industrial chain of the life cycle of medical devices, i.e design and development and production enterprises, operating enterprises, logistics enterprises, scientific research institutions, maintenance service companies, installation companies of medical devices, as well as suppliers or other external parties (such as raw materials, components, parts, medical devices, sterilization clothing) that provide products to medical device organizations Service, calibration service, circulation service, maintenance service, etc.) In two years, China has completed the transition of new ISO standards and attached great importance to the latest ISO13485 standards As early as after the news of the new ISO was released and before the vote was passed, CFDA medical device standard management center held the ISO13485 standard transformation workshop in Beijing on October 29, 2015 The meeting suggested that the equipment enterprises should meet the new changes of international standards, actively transform the old and new standards, and enhance the competitiveness of enterprises According to some analysis, the 2003 version of ISO13485 will expire three years after the release of the new standard It is recommended that the transition period be completed within two years after the 2016 version After 2018, the enterprise will no longer run the 2003 version The production mode and marketing mode of medical devices are constantly changing, and the ISO13485 standard is also constantly changing Before that, in 1996 and 2003, ISO issued two different versions of the standard guide The 2016 version was released and implemented in March 2016 At the same time, China's own medical equipment system has been developed and released Also implemented on May 1 is the administrative measures for recall of medical devices According to the measures, the recall of medical devices is divided into three levels according to the severity of the defects After the medical device manufacturer makes the recall decision, the level-1, level-2 and level-3 recall shall, within one day, three days and seven days respectively, notify the relevant medical device business enterprise, user or user In addition, CFDA also revised the original management measures for medical device standards (for Trial Implementation), which will be implemented as of July 1, 2017 CFDA said the move will play a positive role in guiding the standardization management of medical devices in China, standardizing the formulation and revision of standards, promoting the implementation and improvement of standards, and improving the quality of medical devices.