A cardiac occluder is an implanted apparatus that is delivered to and implanted in the heart through a catheter to block abnormal blood flow.
Application of occluders can date back to over two decades ago but the industry has always been short of relevant industry standards.
Initiated and guided by the Inspection Center of Tianjin Medical Device Quality Supervision Bureau, YY/T 1553-2017 Cardiovascular Implant Heart Industry Standard jointly done by SHSMA and domestic and foreign cardiac occluder manufacturers was officially announced of late.
Drafted in 2015 and with promotion of SHSMA, this standard was reported to CFDA in December, 2015 after multiple discussions, repeated revisions and verification by industry manufacturers and experts.
With joint recognition on the part of domestic experts, this standard was given final approval and officially commenced on October 1, 2018, inaugurating standards and regulation for the occluder industry.
Industry standards for cardiac occluders
This standard specifies definition and range of application of cardiac occluders, and strictly regulates such aspects as initial structural design of cardiac occluders, performance of materials used in production, evaluation standards of finished products, and post-market supervision and management.
This standard also offers provisions on technical requirements, labels and other aspects and reflects that it conforms to marketing and innovation needs.
By continuing to hew to the corporate tenet of the headquarter company to ‘care for life with science’ and putting ‘science taking the lead, making extension and innovation, going after excellence, seeking for integrity and honesty’ as its operational concept, it is to give full play to its two decades of technological accumulation on cardiac occluder and to its sound social credit and make endeavors to boost development of the industry.