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.

Related MDSAP resources from Emergo by UL:

  • On-site MDSAP training for medical device manufacturers
  • MDSAP and Health Canada QMS compliance support
  • Webinar: Overview of the MDSAP certification process

Author

  • Stewart Eisenhart

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