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                国外实验室出具的生物相容性试验报告在中国注册时是否认可?

                  国外实验室出具的生物学㊣ 试验报告,应附有国外实验室表明其符合GLP实验室要求的质量保证文件。若满足相关技术要求(如GB/T 16886/ISO 10993系列标准),则可以作为支持医疗器械生物学评价的生物学试验资料提交。

                  审评三部供稿

                  2018-06-29 10:00