Four Countries to Participate in Pilot Program for Medical Device Audits (ODT Magazine)
FDA Announcement of MDSAP Pilot Program (FDA)
Australia's Therapeutic Goods Administration (TGA) is teaming up with regulatory agencies in Brazil, Canada and the United States to launch a single audit program for medical devices.
The initiative -- which will work in conjunction with Brazil's Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, and the U.S. Food and Drug Administration (FDA), is designed to ensure one quality management system audit is acceptable across multiple regulatory juris...