【关注】MDSAP远程质量体系审核政策将于2022年9月到期

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2022年6月29日，参与医疗器械单一审计计划（MDSAP）的医疗器械市场监管机构们宣布预计于2022年9月，终止由于新冠肺炎病毒流行实施的对质量管理体系进行远程质量体系审核的政策。

据美国FDA发布的MDSAP公告，包括美国FDA、加拿大卫生部、巴西ANVISA、澳大利亚TGA和日本PMDA在内的参与监管的机构，可以在旅行受限、隔离规定等阻碍现场审核的情况下延长远程审核的政策至2022年9月30日。从2022年10月1日开始，在没有出现严重新冠病毒感染的情况下，MDSAP监管机构们将不再继续实行远程审核的规定。

• MDSAP policy for remote quality system audits to expire in September 2022
  

Jul 6, 2022

Medical device market regulators participating in the Medical Device Single Audit Program (MDSAP) plan to end COVID-19-era policies allowing remote audits of quality management systems in September 2022.

According to an MDSAP announcement via the US Food and Drug Administration, participating regulators including the US FDA, Health Canada, Brazil’s ANVISA, the Australian Therapeutic Goods Administration (TGA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) will extend remote audit allowances under certain circumstances until September 30, 2022. Starting October 1, MDSAP regulators will not extend remote audit provisions any further unless significant coronavirus infections occur.

Remote audit allowances are allowed only in cases where travel restrictions, quarantine requirements or social distancing requirements related to COVID-19 prevent or hinder physical inspections of medical device manufacturers’ facilities or systems.

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