MDSAP监督管理委员会（RAC）很高兴地宣布，医疗器械制造商现在被邀请参与医疗设备单审核程序试点。在试点过程中的参与者将为定于2017年开始的项目执行计划修订相应的政策和程序。

MDSAP的试点，于2014年1月1日开始，是对于国际医疗器械监管机构论坛(IMDRF)的基础工作的主动执行。

MDSAP试点的国际合作伙伴有：

• the Australian Therapeutic Goods Administration (TGA),

•澳大利亚治疗物品管理局（TGA），

• the Brazilian National Health Surveillance Agency (ANVISA),

•巴西国家卫生监督局（ANVISA），

• Health Canada, and

•健康加拿大

• the U.S. Food and Drug Administration (FDA);

•美国食品和药物管理局（FDA）；

日本厚生劳动省（MHLW）、药品和医疗器械代理（PMDA）是观察者和积极参与试点项目的监督管理机构理事会和主题专家组。世界卫生组织也是试点方案的观察员之一，并正在就其观察员地位与欧洲委员会进行讨论。

MDSAP试点使医疗设备制造商能够使一个MDSAP试点授权的审计机构对一个医疗设备制造商进行单一审计，这些将满足那些参与试验计划的医疗器械监管部门的相关要求。

MDSAP试点审计报告可以被参与的监管当局使用以代替其自己的检验报告

MDSAP试点审计过程的设计和开发是为了确保一个单一的审计能提供有效而彻底的对医疗设备从质量管理体系要求的覆盖；ISO 13485:2003–医疗器械质量管理体系-用于监管目的要求，巴西GMP（RDC ANVISA 16 / 2013），质量体系法规（21 CFR 820），以及参与MDSAP试点的医疗器械监管部门，包括注册，许可，咨询通告或召回，不良事件报告等等的其他具体要求。

Medical Device Manufacturers Participation in the Medical Device Single Audit Program (MDSAP) Pilot

The MDSAP Regulatory Authority Council (RAC) is pleased to announce that medical device manufacturers are now invited to participate in the MDSAP Pilot. The participants in the process during the pilot will help shape the policies and procedures for the operational program scheduled to begin in 2017.

The MDSAP Pilot, which started on January 1, 2014, is an implementation of the MDSAP initiative based on the foundational work of the International Medical Device Regulators Forum (IMDRF).

The international partners for the MDSAP Pilot are:

 the Australian Therapeutic Goods Administration (TGA),

 the Brazilian National Health Surveillance Agency (ANVISA),

 Health Canada, and

 the U.S. Food and Drug Administration (FDA);

Japan’s Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) are observers and active participants in the Pilot Program’s Regulatory Authority Council and subject matter expert groups. The World Health Organization is also an observer in the Pilot program and discussions are on-going with the European Commission on their Observer status.

The MDSAP Pilot enables medical device manufacturers to have an authorized Auditing Organization under the MDSAP Pilot conduct a single audit of a medical device manufacturer that will satisfy the relevant requirements of those medical device regulatory authorities participating in the pilot program.

MDSAP Pilot audit reports may be used by regulatory authorities participating in the MDSAP Pilot in lieu of their own inspection reports.

The MDSAP Pilot audit process was designed and developed to ensure a single audit will provide efficient yet thorough coverage of the requirements for a quality management system for medical devices derived from; ISO 13485:2003 – Medical devices - Quality management systems – Requirements for regulatory purposes, the Brazilian Good Manufacturing Practices (RDC ANVISA 16/2013), the Quality System Regulation (21 CFR Part 820), and other specific  requirements of medical device regulatory authorities participating in the MDSAP Pilot program including registration, licensing, advisory notices or recalls, adverse event reporting, etc.