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 jurisdictions.
Currently, device manufacturers must comply with different quality system standards such as FDA's Quality System Regulations in the United States, ISO 13485 in Europe and Brazil's Good Manufacturing Practices (BGMP) in order to register their products in those markets. The Medical Device Single Audit Program (MDSAP) would spur more widespread use of third-party auditors alongside regulatory inspectorates, according to the TGA, to enable governments to focus their resources on higher-risk devices and adverse events.
Although the MDSAP pilot involves only Australia, Brazil, Canada and ...
