Speaking at RAPS' 2017 Convergence on Monday, officials from two international regulators and representatives from auditing organizations offered the latest on the Medical Device Single Audit Program (MDSAP).
MDSAP is an effort by regulators in the Australia, Brazil, Canada, Japan and the US to establish a single audit process, conducted by recognized third-party auditors, that can meet the requirements of regulators in each country. For manufacturers, MDSAP offers an opportunity for fewer audits and less disruption.
In June, MDSAP released its final report detailing the program's experience through its pilot phase and into Q2 2017. While the pilot failed to attract as much interest as initially hoped during the pilot phase, the number of participating manufacturers doubled from 157 at the end of 2016 to 326 by the second half of 2017.
Since completing its pilot phase, four auditing organizations have become fully recognized to conduct MDSAP audits: BSI Group, TÜV SÜD America, Intertek Testing Services and Underwriters Laboratories.
Nine more auditors have been cleared to conduct three "witnessed" audits that are required to support full recognition and are in various stages of completing those audits. And one auditor, NSF, has applied to participate.
But despite the increase in the number of auditors working to participate in the program, the way regulators use the results of MDSAP audits vary.
For instance, in Australia, the Therapeutic Goods Administration (TGA) will accept a MDSAP certificate as proof of compliance with ISO 13485 when a TGA certificate of conformity (CAC) is not required. When a TGA CAC is required, TGA will still take MDSAP certificates into consideration and a MDSAP certificate may help a manufacturer avoid a routine inspection by TGA.
In Japan, Brazil and the US, MDSAP audit reports can be used as a substitute for routine inspections in certain circumstances.
Of all the participating agencies, Health Canada is the only regulator that is requiring companies to undergo MDSAP audits.
Beginning 1 January 2019, companies marketing Class II, III and IV devices in Canada will need a valid MDSAP certificate to get, 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 will face having their device licenses suspended.
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.