审核依据各国医疗器械相关法规，分别如下：

l 美国: 21 CFR Part 820/21 CFR Part 821/21 CFR Part 803,806,807

l 加拿大：Medical Device Regulations – Part 1 – SOR 98/282

l 澳大利亚：Therapeutic Goods Regulations, 2002, Schedule 3 Part 1 （excluding 1.6） – Full Assurance Procedure/Therapeutic Goods Regulations, 2002, Schedule 3, Part 4- Production Assurance Procedure

l 巴西：RDC ANVISA N. 16/2013, 23/2012, 67/2009

l 日本：MHLW MO169/ PMD Act