Medical Device Single Audit Program Gains Momentum

Companies most likely to benefit from the Medical Device Single Audit Program will include those selling products in Canada, along with manufacturers of finished medical devices and high-risk devices, said MDSAP expert Brian Ludovico, in an FDAnews webinar.

Devicemakers selling products in Canada must comply with the single audit requirement by March 2019. Health Canada will expect all device licenses to be supported by MDSAP audits by that time, and if a manufacturer doesn’t have a MDSAP certificate, its license will be suspended, said Ludovico, executive director of MDSAP regulatory certification at NSF Health Sciences.

Companies selling their devices in other regions covered by the MDSAP Consortium — which currently includes Australia, Brazil, Canada, Japan and the U.S. — should be aware that information from the Canadian audit will be shared with the regulators in the other regions.

For example, if a company sells devices in Canada, the U.S. and Australia, it will be required by Canada to be certified under MDSAP, and the FDA and the TGA will have access to the audit reports.