MDSAP Single-Audit Pilot on Schedule; Companies Encouraged to Apply

September 17, 2014

The International Medical Device Regulators Forum’s single-audit pilot program is running on schedule, an FDA official working closely with the program says.

The pilot launched in January, and two third-party auditing groups were ready to start conducting inspections in June, as planned.

A total of six auditing organizations submitted applications and submitted to assessments by the participating regulatory authorities — the FDA, Health Canada, Australia’s Therapeutic Goods Administration and Brazil’s Anvisa. The initial goal was to get three to five groups to apply, says Kimberly Trautman, associate director of international affairs at the FDA and chair of IMDRF’s Medical Device Single-Audit Program Working Group.

Audits to Begin This Month

“By June, we had two organizations that had successfully completed all their assessment activities except the witness audits, so those two auditing organizations are authorized already to start MDSAP audits,” she says. Some of the audits are scheduled to occur this month.

The other four organizations are continuing with their assessment activities, and additional groups are scheduled to submit their applications in the June-to-December timeframe. Trautman says MDSAP needs more industry volunteers and will continue to solicit manufacturer involvement.

Companies that use Canadian Medical Devices Conformity Assessment System audits are the most likely candidates for the MDSAP pilot, according to Trautman. Devicemakers interested in participating in the pilot should request that their next scheduled audit be converted from CMDCAS to MDSAP.

“MDSAP takes all requirements of all four jurisdictions and puts them into one audit,” the FDA official says. The program is directly linked with Canada because, of the four participating jurisdictions, Canada is the only one with a third-party auditor system.

Brazil was added to the pilot to provide more incentives for manufacturers to do consolidated audits, Trautman notes. The country currently has a five-to-seven-year inspections backlog for manufacturers outside the country.

Once a third party completes an audit, each jurisdiction can utilize the results.

MDSAP Replaces Routine Audits

“The FDA uses MDSAP as a routine audit,” Trautman says. “The FDA can’t replace a preapproval inspection with it or a directive-for-cause inspection, but for the majority of inspections we do, which are routine, we have a MDSAP inspection report and we will count that as our FDA routine audit.”

In Canada, companies won’t be asked to get an additional inspection or audit, “but when the next CMDCAS audit comes up, they can convert it to a MDSAP, so they can use it for Canada and in other jurisdictions as well,” she adds.

Japan, one of IMDRF’s founding members, is currently an observer of the single-audit program, but intends to participate after it finishes transposing 2013 device legislation into regulation. That could happen as soon as next spring, she adds.

The EU as a trading block, on the other hand, is unlikely to be able to participate fully, as each member state would need to make confidentiality agreements with each of the other 27 member states. It can, however, be an observer.

Trautman provided an update on the MDSAP initiative yesterday, during IMDRF’s fourth semiannual meeting in Washington, D.C. Further sessions today and tomorrow will focus on regulatory harmonization, an important element of MDSAP. The group’s next meeting is scheduled for March 25-27, 2015, in San Francisco. — Jonathon Shacat

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