在学习、贯彻新版《医疗器械监督管理条例》(以下简称《条例》)的过程中,许多人都注意到了一个从未有过的情况,即第三十九条规定,由食品药品监督管理部门对使用环节的医疗器械质量进行监督管理。其道理不难明了:除了耗材和一次性产品之外,绝大部分医疗器械,尤其是其中的仪器类,往往要持续使用多年,无论多么结实、先进,都逃不脱自然老化、使用加速老化的客观规律,难以避免出于各种原因的损坏;功能的丧失、性能的退化必然导致安全有效性的降低,危及患者的身体健康和生命安全;在 During the study and implementation of the new Regulations on the Supervision and Administration of Medical Devices (hereinafter referred to as the “Regulations”), many people noticed an unprecedented situation where Article 39 stipulates that the food and drug regulatory authority The use of the quality of medical devices to carry out supervision and management. The reason is not hard to understand: In addition to supplies and disposable products, the vast majority of medical devices, especially those instruments which are often used for many years, no matter how strong, advanced, can not escape the natural aging, the use of accelerated aging Of the objective laws, it is difficult to avoid damage for a variety of reasons; loss of function, performance degradation will inevitably lead to reduced safety and efficacy, endangering the patient’s health and safety of life; in