The Medical Device Single Audit Program Regulatory Authority Council authorized NSF Health Sciences as an official auditing organization.
The MDSAP program continues to gain momentum as a cornerstone of the International Medical Device Regulators Forum (IMDRF) initiative for aligning international medical device regulations. MDSAP auditing organizations help ensure manufacturers across all participating jurisdictions are meeting the quality management system requirements of ISO 13485.
IMDRF gained its 10th member, South Korea, late last year, joining the U.S., Europe, Canada, Australia, Japan, Brazil, China, Russia, and Singapore.
The way MDSAP audit reports will be used varies among the different jurisdictions. For example, the U.S. FDA intends to substitute them for routine medical device inspections whereas Health Canada will use them as part of marketing clearances, making the audit certificates a requirement for high-risk devices, beginning Jan. 1, 2019.