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各国对MDSAP的认可程度

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审核证书以及CMDCAS认证审核证书。自2019年1月1日开始,加拿大药监局将只接受MDSAP的审核证书。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 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.

相关链接:
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:

  • MDSAP的审核的时间可以与审核机构一起确定;
  • FDA对于MDSAP的审核报告会进行严格的评估;
  • 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);
  • 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;
  • 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 Radiological Health – FDA
– will accept the MDSAP Pilot audit reports as a substitute for FDA routine inspections (biennial by policy). Additional benefits include:

  • MDSAP Pilot routine audits are announced, scheduled by the Auditing Organization with the manufacturer, with a pre-established duration;
  • 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;
  • Firms have one month to provide their full response to critical nonconformities (grade 4 and 5) to the Auditing Organization (as opposed to 15 working days following a FDA inspection);
  • Certification documents issued by the Auditing Organization state compliance with applicable US regulations, which may provide a marketing advantage;
  • ?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.fda.gov/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审核证书。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证书更新,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.

 

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