MDSAP Extends Remote Auditing Option

The International Medical Device Regulators Forum (IMDRF) has temporarily extended the limited use of remote auditing options under the scope of its Medical Device Single Audit Program (MDSAP).

According to a Notice, MDSAP audits may be conducted remotely until September 30, 2022, solely in cases where on-site audits cannot be conducted due to travel restrictions, quarantine orders, or social/physical distancing requirements in response to the COVID-19 pandemic. However, MDSAP authorities make clear that the use of remote audits for any other purposes is not permitted.

The MDSAP allows recognized auditing organizations to conduct a single audit of a medical device manufacturer’s facility that meets the regulatory requirements of all MDSAP-participating countries. Countries that participate in MDSAP include the U.S., Australia, Brazil, Canada, and Japan. Representatives from the World Health Organization (WHO) Prequalification of In Vitro Diagnostics Programme and from the European Union are designated as official observers to MDSAP discussions.

Read the IMDRF’s Notice regarding the temporary extension of remote audits.

Read additional information about the MDSAP is available on the website of the U.S. Food and Drug Administration.

Leave a Reply

Your email address will not be published.