yy/t0287-云顶集团3118

in january 19, 2017, the state food and drug administration issued the "yy/t0287-2017 /iso13485:2016" standard for the quality control system of medical devices, which will be implemented in may 1, 2017.
yy/t0287-2017 "the requirements of the medical equipment quality management system for the regulations" (hereinafter referred to as the new standard) is equivalent to the use of the iso13485:2016 standard. along with the development of the reform of society, economy, the rise of a new round of industry of science and technology revolution has a significant and far-reaching impact on the medical industry, medical equipment production and marketing mode is changing, especially the speed of global market integration process, resulting in the medical device industry chain extension and more complex, many countries including china, the world have been adjusted or modification of the medical devices regulations, in order to adapt to the new situation of supervision. for dealing with common challenges in medical equipment industry and supervision, the international organization for standardization (hereinafter referred to as iso) on 2011 officially launched the iso13485:2003 "quality management system for medical equipment regulations" revision, released in march 1, 2016 iso13485:2016 "quality management system for medical equipment regulations". considering the important role of iso13485 standard of medical quality management, administration management department always closely follow the standard revision process, combined with china's medical equipment industry and regulatory practice, propose amendments to the iso standard positive comments and suggestions, and make timely standard conversion work.
the new standard to further highlight the regulations as the main line, more emphasis on the importance and necessity of implementing the laws and regulations, improve the compatibility of the regulations and standards; the quality management system standards applicable to the medical devices in each stage of life cycle of the industrial chain of medical organizations, to further ensure the each stage of the life cycle of the safety of medical devices effective; strengthen the new requirements of risk analysis and risk management based on; put forward new requirements for medical equipment procurement and supply chain; at the same time also added new requirements of post market medical device supervision and improvement.
the implementation of new standards, will strengthen the overall convergence of regulatory requirements and medical quality management system, give full play to the supporting role of medical device supervision, and the supervision and administration of medical devices regulations complement each other, with strong, more intensive medical equipment organization of the safety of the main responsibility, strengthen the quality management of medical equipment the life cycle, promote the supervision department, industry and the third party to participate in social governance jointly safeguard the safety and effectiveness of medical devices. at the same time, it is also conducive to the rapid development and application of new technologies and quality management system for medical devices, and to promote the development and regulatory requirements of china's medical device industry in line with international standards, so as to enhance the healthy development of medical device industry and the continuous improvement of its regulatory level.
the administration will continue to do a good job in the new edition of the standard implementation and implementation, combined with the full implementation of medical equipment production and quality management practices, promote the establishment and improvement of the quality management system of medical equipment manufacturing enterprises. third party, medical equipment enterprises should actively carry out yy/t0287-2017/iso13485:2016 standards of learning, publicizing and training work. medical equipment enterprises to understand and master the new edition of the standard concept, principle, method and new requirements, strict risk management to carry out product and process, and constantly improve and improve the quality management system, strengthen the main responsibility for quality and safety, improve the quality management system adequacy, effectiveness and suitability, and promote the healthy development of medical equipment industry.