September 27, 2017
As reported in a recent Regulatory Focus article for the Regulatory Affairs Professionals Society (RAPS), officials from two international regulators and representatives from auditing organizations offered the latest on the Medical Device Single Audit Program (MDSAP), confirming a fast-approaching deadline.
"According to Nancy Shadeed, special advisor to Health Canada's International Programs Division, the agency is still intent on sticking to the 2019 deadline, despite some concerns from industry that the deadline may be difficult to meet.
And according to Patricia Murphy, global head of MDSAP programs at BSI, companies marketing devices in Canada will need to ramp up their participation to meet the 2019 deadline.
'We have seen three times the number of requests from 2016 into 2017, and knowing how many CMDCAS certificates are still out there, even that three times increase is not going to get us to where we need to,' Murphy said."
Earlier this summer, FDA released its final report on the Medical Device Single Audit Program (MDSAP) pilot program, which detailed the results of its official pilot phase into Q2 2017.
Despite falling short of the participation goals the program had hoped to meet during the pilot, the number of participating manufacturers doubled from December 2016 (157), to 326 by the second half of 2017 (326).
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There have also been other significant developments, including:
• The addition of four auditing organizations that are officially cleared to conduct MDSAP audits
• The addition of nine auditors who have been cleared to conduct the three "witnessed" audits required to support full recognition
Perhaps the most pressing component on the MDSAP timeline is the impending deadline for companies marketing Class II, III, and IV devices in Canada. Currently, Health Canada is the only regulator that is requiring companies to undergo MDSAP audits as of January 1, 2019.
After this date, companies marketing devices in Canada will need a valid MDSAP certificate to obtain, maintain, or amend a medical device license. Companies that have not transitioned from their Canadian Medical Device Conformity Assessment System (CMDCAS) certificates to MDSAP ones may have their device licenses suspended.
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