FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

IMDRF Stakeholders Report on MDSAP and Other Challenges

Oct. 23, 2017
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As Health Canada’s December 2018 deadline for conformity with the Medical Device Single Audit Program approaches, industry stakeholders say the 15-day window for devicemakers to provide a remediation plan in response to a nonconformity finding is too narrow.

Meeting the deadline will prove challenging for many devicemakers, and the shortage of certified auditors also remains a barrier, said Patrick Hope, executive director of the Global Diagnostic Imaging, Healthcare IT & Radiation Therapy Trade Association (DITTA).

DITTA members also see challenges ahead because of variable interpretations among auditing organizations, particularly with regard to outsourced activities, Hope said at last month’s IMDRF meeting in Ottawa, Canada.

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