U.S., Canada Release Timelines For MDSAP Co-Guidances

04 Jun 2015

Neighboring regulators expect Medical Device Single Audit Program draft guidances to be out in June.

The U.S. Department of Commerce has released an annual work plan that outlines the ongoing efforts between the United States and Canada to align their medical device regulations. Among the initiatives, the governments are working together on finalizing Medical Device Single Audit Program (MDSAP) guidances.

FDA, Health Canada, and Brazilian and Australian regulators have been collaborating through the International Medical Device Regulators Forum (IMDRF) to...