加拿大：
MDSAP审核将取代CMDCAS认证成为医疗器械在加拿大上市的唯一途径，即使该器械仅在加拿大上市。MDSAP审核取代CMDCAS将于2017年1月1日开始实施，试运行两年。在此期间，加拿大药监局将同时接受MDSAP审核证shu以及CMDCAS认证审核证shu。自2019年1月1日开始，加拿大药监局将只接受MDSAP的审核证shu。加拿大药监局对于MDSAP的认可，是基于与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 whena 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
ISO13485, which is anticipated to be published in early
2016.
相关链接：
https://www./en/health-canada/services/drugs-health-products/medical-devices/activities/international/notice-transition-plan-medical-device-single-audit-program.html
美国：
MDSAP审核将替代FDA两年一次的周期性审核。这样将会带来以下的好处：
Ø MDSAP的审核的时间可以与审核机构一起确定；
Ø FDA对于MDSAP的审核报告会进行严格的评估；
Ø 接受MDSAP审核的企业将有一个月的发补时间去应对审核机构提出来的不符合项（FDA只提供15个工作日）；
Ø MDSAP审核过的文件是符合美国相关法规的要求，可作为获得市场认可的优势；
Ø FDA 授权MDSAP审核机构对审核中开出的不符合项进行跟进,因此FDA不会开483或警告信,除非不符合升级到FDA所必须采取行动的措施。
United States:U.S.Food and Drug Administration’s
Center for
Devices and Radio logical
Health – FDA
– will accept the MDSAP Pilot
audit reports as a substitute for FDA routine inspections (biennial
by policy).
Additional benefits include:
l MDSAP Pilot
routine audits are announced, scheduled by the Auditing
Organization withthe manufacturer, with a pre-established
duration;
l The FDA
will review MDSAP Pilot audit reports with a level of scrutiny
commensurate to
the significance of audit findings, taking into account the review
and follow-up
performed by the Auditing Organization;
l Firm shave
one month to provide their full response to critical
non conformities(grade
4 and 5) to the Auditing Organization (as opposed to 15 working
days following
a FDA inspection);
l Certification documents
issued by the Auditing Organization state compliance with
applicable US regulations,which
may provide a marketing advantage;
l FDA will utilize other forms
of Advisory Notice, where necessary instead of FDA Warning Letters
for MDSAP
Audits during the Pilot. Warning Letters will only be considered
when the MDSAP
audit conclusion reveals an imminent/unreasonable risk to public
health.
相关链接：
https://www./downloads/medicaldevices/internationalprograms/mdsappilot/ucm429958.pdf
巴西：
ANVISA将采用MDSAP审核结果及审核报告作为ANVISA产品上市前注册及上市后质量体系评估的重要依据。适当时，该信息将帮助ANVISA在法规技术方面对企业进行评估。
根据最近法规(RDC15 )的变化，ANVISA将使用MDSAP审核替代原ANVISA三类或四类医疗器械企业的BGMP审核证shu。接受MDSAP审核意味着ANVISA的BGMP审查进程将会加速。ANVISA同时会使用MDSAP的审核报告来替代ANVISA一年两次的BGMP证shu更新，这意味着MDSAP的审核会是ANVISA审核的一个替代品。
Brazil: The Brazilian National Health
Surveillance Agency – ANVISA will
utilize the outcomes of the program, including the reports, to
constitute an
important input on ANVISA’s pre-market
and post-market assessment procedures, providing, when
applicable,key information that are expected to support regulatory
technical evaluation on these
issues.
Due to recent
regulatory changes (RDC 15:2014), ANVISA may use MDSAP Pilot audits
in lieu
of a premarket inspection by ANVISA to grant ANVISA’s GMP
Certificate to manufacturers
intending to put medical devices of class III or IV on
the Brazilian
market. Undergoing an MDSAP Pilot audit may accelerate ANVISA´s
GMP certification
process, which is a pre-requisite to the marketing
authorization.ANVISA can also use MDSAP Pilot audits to renew
ANVISA’s GMP Certificate bi-annually,
as an alternative to an ANVISA comprehensive inspection.
相关链接：
http://portal./resultado-de-busca?p_p_id=101&p_p_lifecycle=0&p_p_state=maximized&p_p_mode=view&p_p_col_id=column-1&p_p_col_count=1&_101_struts_action=/asset_publisher/view_content&_101_assetEntryId=2869856&_101_type=document&redirect=http://portal./resultado-de-busca?p_p_id=3&p_p_lifecycle=0&p_p_state=normal&p_p_mode=view&p_p_col_id=column-1&p_p_col_count=1&_3_groupId=0&_3_keywords=MDSAP&_3_cur=1&_3_struts_action=/search/search&_3_format=&_3_formDate=1441824476958
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