以上下肢主被动康复训练设备为例浅谈运动康复医疗器械审评关注点

Taking the Above Lower Limb Active and Passive Rehabilitation Training Equipment as an Example,a Brief Discussion on the Focus of Evaluation of Sports Rehabilitation Medical Equipment

近年来,康复医学发展迅速,康复医疗市场得到持续释放,更多的医疗器械企业开始涉足运动康复医疗器械产品。文章以上下肢主被动康复训练设备为例,结合医疗器械注册申报资料要求与说明,以及其他现行法规和标准,浅谈运动康复医疗器械审评关注点,以期为医疗器械行业的申报人和审评人员提供参考。

In recent years,the rapid development of rehabilitation medicine,rehabilitation medical market has been sustained release,more medical device companies began to involve in sports rehabilitation medical device products.In this paper,the author takes the active and passive rehabilitation training equipment for upper and lower limbs as an example,combining the requirements of registration and declaration of medical devices with other current regulations and standards,discusses the original concerns of the examination and approval of sports rehabilitation devices,with a view to the medical device industry to provide a reference for filers and reviewers.