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Medical Devices / Inspections and Audits

MDSAP Participants, Regulators Consider the Program’s Future

Sept. 28, 2017
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MDSAP participants identified actions for improving the program at 2017 RAPS Convergence.

Although the program will not become fully operational until Jan. 1, 2019, participating manufacturers and auditing organizations have begun to prepare for how MDSAP regulatory authorities will use program outcomes differently across different countries.

For example, Health Canada will use MDSAP certificates to decide on whether to issue device licenses, while program audit reports submitted to the CDRH will be accepted as substitutes for routine FDA inspections, Nancy Shadeed, special advisor at Health Canada’s International Programs Division, explained during the session at the conference.

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