The following contents should be noted in the development of the performance requirements and performance indicators for the suture in suture anchors:
- In the process of product design and development, the performance and performance indicator requirements of the suture should be determined from the perspective of the clinical needs and intended use of the product, and combined with the applicable site of the product and the specific use method, while comprehensively considering the quality control for the suture itself.
- Suture anchor is usually used for the fixation of bones and soft tissues. It is class III medical device, different from the non-absorbable surgical sutures as class II medical device. The administrative counterpart should pay attention to the applicability of the standard when referring to relevant national or industry standards.
