Medical Device Single Audit Program (MDSAP)

The Medical Device Single Audit Program (MDSAP) is a program that allows the conduct of a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions. These are some MDSAP FAQ  that might help you with your doubts.

• We sell in Canada. Is MDSAP required?

Yes, you’ll need a MDSAP if you want to sell any Class II, class III, or class IV devices in Canada. If you sell only Class I devices, you do not need MDSAP certification.

• We only sell in the US and Europe. Do we need MDSAP

No. Europe is not a participant in the MDSAP program and the US FDA does not require participation at this time, so it would not make any sense to get MDSAP certified unless you knew for certain that you plan to expand sales into Canada, Brazil, Japan, or Australia. Even then, you will need to weigh the costs of compliance with MDSAP against your sales potential in those markets. Canada is the only market that requires MDSAP certification.

• What language will be used for the MDSAP audit reports?

Per MDSAP AU P0019.004, section 2.2 Report Language: “The language of the report is subject to the operating language of the auditing organization and should be understandable by the manufacturer; however, all audit reports must also be available in English.” The manufacturer should clarify this with their AO along with any other report needs 

• Is the MDSAP Stage 1 Documentation Review part of the audit time calculation?

The Stage 1 Documentation Review is not part of the audit time calculation. Per MDSAP P0008.006 Audit Time Determination Procedure, for initial certification audits the auditor will calculate the duration of Stage 2 using the assigned minutes per task in MDSAP P0008 and then “add 25%. The result will reflect the duration of audit (i.e., time necessary to perform Stage 1 and Stage 2.” The AO may combine elements of Stage 1 and Stage 2 to allow for a single on-site visit to the manufacturer.

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