News Feature | November 5, 2013

Regulators Flesh Out Details On International Medical Device Audit Program

By Sara Jerome,

Regulators in Australia, Brazil, Canada, and the U.S. are taking the next step toward streamlining the quality system inspection process for medical devices across international borders, under the Medical Device Single Audit Program (MDSAP).

An MDSAP pilot program exploring that possibility will launch in January, the FDA said in a document released last week. Auditing organizations are expected to be ready to start performing MDSAP audits for medical device manufacturers by June 2014.

Although only four countries are participating in the pilot, various members of the regulators-only group International Medical Device Regulators Forum (IMDRF) support the effort, the document said.

For instance, although Japan is not officially participating, "both the Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical Devices Agency are acting as observers," Stewart Eisenhart, an analyst at Emergo Group, wrote in a blog post. "This suggests more involvement by Japanese medical device regulators [in the pilot] further down the line." 

The FDA is fully participating. When the pilot launches, the FDA will accept the pilot program audit reports as "a substitute" for FDA routine inspections, the agency said.

"Inspections conducted 'For Cause' or 'Compliance Follow-up' by FDA will not be affected by this program. Moreover, this MDSAP program would not apply to any necessary pre-approval or post approval inspections for Premarket Approval (PMA) applications or to decisions under section 513(f)(5) of the Act (21 U.S.C. 360c(f)(5)) concerning the classification of a device," the FDA document said. 

In a notice announcing the planned pilot launch, Australia's Department of Health said the effort was prompted by recognition of "the increasingly global nature and number of medical device manufacturers." 

At a regulatory meeting last year, Health Canada's Mike Ward called the program the "future of regulation," according to Regulatory Focus

The IMDRF is taking a lead role in organizing the pilot.