医疗机构临床加工制作医疗器械行为亟待加强监管

Behavior of Clinical Making Medical Devices by the Medical Treatment Organization Needs to be Strengthened Supervision

自《医疗器械监督管理条例》实施以来,我国医疗器械生产?流通领域的秩序得到了全面规范。但《医疗器械监督管理条例》对医疗机构加工制作医疗器械的行为应如何监管没有作出任何规定,形成了监管盲区。针对医疗机构加工制作医疗器械存在的问题?原因及监管措施,谈几点个人看法。

Since Regulations for the Supervision and Administration of Medical Devices was carried out on Apr. 1st, 2000, Our medical devices＇ production and the order in the field of circulation have been completely purified and normalized. But Regulations for the Supervision and Administration of Medical Devices has no regulations governing medical devices maked by the medical treatment organizations. Therefore, they haven＇t been effectively taken charge of. It has been a blind area of supervision. Aimed at the existent problems, reasons and supervision measures, the writer states personal viewpoints.