The Medical Device Single Audit Program (MDSAP) is an international initiative designed to harmonize regulatory efforts globally.
From January 2014 to December 2016, FDA and international partners participated in an MDSAP pilot program. In June 2017 a report was generated summarizing the outcomes of prospective proof-of-concept criteria established to confirm the viability of the Medical Device Single Audit Program. Based on its evaluation of the MDSAP Final Pilot Report, the MDSAP Regulatory Authority Council (the international MDSAP governing body) determined that the MDSAP Pilot has demonstrated the viability of MDSAP.
In the United States:
FDA will continue to accept MDSAP audit reports as a substitute for routine Agency inspections. It will reduce the number of inspections by the agency, improve the efficiency, and consistency of audits across the industry.
On January 1, 2019, Canada will require companies selling Class II, III and IV (Canadian classes of medical devices correspond to the European Council Directive 93/42/EEC, and class IV generally corresponds to Class III, ECD) medical devices and IVDs to have a MDSAP certificate to maintain their Medical Device Licenses. MDSAP will replace the current Canadian Medical Device Conformity Assessment System (CMDCAS) as a way to demonstrate quality management system compliance to ISO 13485 and the Canadian Medical Devices Regulations (CMDR).
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