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…
