7诡蜓、MDSAP審核的依據(jù)是什么?
審核依據(jù)各國醫(yī)療器械相關法規(guī)，分別如下:
美國: 21 CFR Part 820/21 CFR Part 821/21 CFR Part803,806,807.
加拿大: Medical Device Regulations-Part 1-SOR 98/282.
澳大利亞:
Therapeutic Goods Regulations, 2002, Schedule 3 Part 1(excluding 1.6)- full Quality AssuranceProcedure/Therapeutic GoodsRegulations, 2002, Schedule 3, Part 4- Production Quality AssuranceProcedure.
巴西: RDC ANVISA N.16/2013,23/2012,67/2009.
日本: MHLW MO169/ PMD Act.
