International Single-Audit Program on Track for 2019
The International Medical Device Regulators Forum’s single-audit program remains on track for full implementation in 2019, and companies should be shoring up their internal auditing processes to prepare.
MDSAP was devised to leverage regulatory resources into a single audit program so that manufacturers didn’t have to contend with numerous inspections throughout the year, said Susan Reilly, president of consultancy Reilly Associates, during a recent FDAnews webinar.
Regulatory authorities participating in the program are: Australia’s Therapeutic Good Administration; Brazil’s ANVISA; Health Canada; Japan’s Ministry of Health, Labour and Welfare; and the U.S. FDA. — Jason Scott