为了保护病人及医务人员免受未经证明是安全有效的生物医学产品的危害,德国规定这类产品的可靠性必须通过医疗设备管制的检测。这种规定限制了一些中小型企业的生产和销售,使其生产限定在其生产能力范围内。生产商、科研机构、医疗及相关保险公司之间的联合合作可促使生物医学产品能够经济、有效、迅速地发展。 In order to protect patients and medical personnel from the unmanifested and biomedical products that are safe and effective, Germany stipulates that the reliability of such products must be governed by medical device controls. This provision has limited the production and marketing of some small and medium-sized enterprises, limiting their production to the limits of their production capacity. The joint collaboration between manufacturers, research institutes, medical and related insurers can facilitate the economic, efficient and rapid development of biomedical products.