Salem, New Hampshire -- TUV USA, Inc. announced today that as of September 5, 2018, TUV USA has received full recognition as a Recognized Auditing Organization under the MDSAP Program.
In 2014, a few third-party auditing organizations were chosen to be part of the Medical Device Single Audit Program (MDSAP). The idea was to create a program that would aid in the easing of trade barriers for international medical device companies who would wait several years just to have their applications approved to sell to a new jurisdiction. The manufacturers would then face a rigorous and exhaustive annual audit program from each jurisdiction to which they sold, sometimes taking many weeks to complete for larger organizations. MDSAP was created as a solution to this.
MDSAP represents an agreement between member countries to accept the involvement of third-party auditing organizations to improve the approval processes, reduce the workload on Regulatory Authorities, and reduce the number of audits from Regulatory Authorities that medical device manufacturers have to coordinate. To date, there are five jurisdictions involved in MDSAP: Australia, Brazil, Canada, Japan, and the United States.
This has been an exciting journey for all of us involved, and we are looking forward to seeing how the MDSAP program further develops! TUV USA is proud to be one of the few certification bodies providing the new MDSAP certification.
