The current Medical Device Single Audit Program (MDSAP) Regulatory Authority Council (RAC) Members recognize the benefits of the program being used by other regulatory authorities as well as the potential contributions and benefits of additional program membership. However, while the MDSAP pilot demonstrated the program’s viability, the program has only recently moved to its operational transition phase working towards full implementation in all the currently participating jurisdictions. The program needs more time to settle and stabilize in our jurisdictions and with manufacturers before broadening its membership and potential scope. This is because of the complexity of already incorporating the regulatory requirements of 5 regulatory authorities into one audit program. Additionally, candidate Auditing Organisations are either still at various stages of gaining recognition against the current MDSAP audit recognition criteria or gaining experience executing the MDSAP audit model and processes.
While additional membership to the program beyond current members and observers is not feasible at this time, other regulatory authorities may wish to use MDSAP certificates as part their decision making. Access to MDSAP audit reports however, would be at the discretion of the participating medical devices manufacturers.
The MDSAP Regulatory Authority Council would appreciate any feedback from jurisdictions who are utilizing MDSAP audits. We appreciate your continued support and interest in MDSAP.