NSF Health Sciences Certification, LLC, a wholly owned subsidiary of NSF International, was recently authorized as an official Auditing Organization (AO) by the Medical Device Single Audit Program (MDSAP) Regulatory Authority Council.

MDSAP is a global auditing and monitoring program to improve safety and oversight in manufacturing non-active, active, active implantable and in vitro diagnostic medical devices. The authorization enables NSF International to conduct a single regulatory audit that covers the quality management system requirements in ISO 13485 and the specific regulatory requirements of all participating jurisdictions, which include the United States, as well as Australia, Brazil, Canada, and Japan.

The authorization is the culmination of a lengthy effort by NSF International’s Medical Device Regulatory Certification program staff. In addition to the application process, AO authorization requires a rigorous, two-stage assessment by regulatory authorities.

“This third-party audit model allows for greater coverage in auditing manufacturers around the globe,” says Kim Trautman, executive vice president of medical device international services at NSF International. “The benefits are two-fold in that government resources can be focused on high-risk or problematic medical devices and manufacturers that are not in compliance with the regulations, and manufacturers will be able to have one audit to satisfy the requirements of all participating regulatory jurisdictions.”

Health Canada utilizes the MDSAP Certificate as part of its Class II and III licenses for market entry, and the U.S. FDA uses them as a substitute for their regulatory inspectorates’ audit reports for routine medical device inspections.

“As the confidence in the reliability of third-party audits grows, other regulatory authorities will leverage this information to limit the need for additional audits,” says Brian Ludovico, executive director of medical device regulatory certifications at NSF International.