加拿大：

MDSAP審核將取代CMDCAS認(rèn)證成為醫(yī)療器械在加拿大上市的唯一途徑，即使該器械僅在加拿大上市。MDSAP審核取代CMDCAS將于2017年1月1日開始實(shí)施，試運(yùn)行兩年。在此期間，加拿大藥監(jiān)局將同時(shí)接受MDSAP審核證書以及CMDCAS認(rèn)證審核證書。自2019年1月1日開始，加拿大藥監(jiān)局將只接受MDSAP的審核證書。加拿大藥監(jiān)局對(duì)于MDSAP的認(rèn)可，是基于與ISO13485:2016的更新保持一致。

Canada:MDSAP will replace the current Canadian Medical Devices Conformity Assessment System (CMDCAS) program, even in situations when a manufacturer intends to sell only in Canada. This implementation will begin at the conclusion of the Pilot on January 1, 2017, and will span a period of two years. During this two year period, Health Canada will accept certificates issued under both CMDCAS and MDSAP. As of January 1, 2019, only MDSAP certificates will be accepted. Further details will be released as the transition plan is finalized. Health Canada's transition to MDSAP is an attempt to align with the transition period for the revised version of ISO 13485, which is anticipated to be published in early 2016.

相關(guān)鏈接：
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/activities/international/notice-transition-plan-medical-device-single-audit-program.html

美國(guó)：

MDSAP審核將替代FDA兩年一次的周期性審核。這樣將會(huì)帶來(lái)以下的好處：

ANVISA將采用MDSAP審核結(jié)果及審核報(bào)告作為ANVISA產(chǎn)品上市前注冊(cè)及上市后質(zhì)量體系評(píng)估的重要依據(jù)。適當(dāng)時(shí)，該信息將幫助ANVISA在法規(guī)技術(shù)方面對(duì)企業(yè)進(jìn)行評(píng)估。