Can the manufacturer exclude a jurisdiction or products from the scope of an MDSAP audit?

A manufacturer may exclude the requirements of a jurisdiction where the organization does not intend to supply medical devices. In other words, audit criteria under the MDSAP include at a minimum ISO 13485 and the applicable regulations in any of the participating RA’s jurisdiction where the organization supplies medical devices. The MDSAP audit scope is expected to include all products that are supplied to a participating MDSAP jurisdiction.