The Medical Device Single Audit Program (MDSAP) is a program that allows the conduct of a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions. Audits are conducted by Auditing Organizations authorized by the participating Regulatory Authorities to audit under MDSAP requirements. The MDSAP is a way that medical device manufacturers can be audited once for compliance with the standard and regulatory requirements of up to five different medical device markets: Australia, Brazil, Canada, Japan and the United States. The program’s main mission is to “…jointly leverage regulatory resources to manage an efficient, effective, and sustainable single audit program focused on the oversight of medical device manufacturers.”
The MDSAP was developed by representatives of the Australian Therapeutic Goods Administration (TGA), Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, MHLW/PMDA, and the U.S. Food and Drug Administration (FDA). All regulatory authorities participating in the MDSAP are equal partners in the program.
United States: U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health, will accept the MDSAP audit reports as a substitute for FDA routine inspections (biennial by policy). Additional benefits include: · MDSAP routine audits are announced, scheduled by the Auditing Organization with the manufacturer, with a pre-established duration; · The FDA will review MDSAP audit reports with a level of scrutiny commensurate to the significance of audit findings, taking into account the review and follow-up performed by the Auditing Organization; · Firms have one month to provide their full response to critical nonconformities (grade 4 and 5) to the Auditing Organization (as opposed to 15 working days following and FDA inspection); · Certification documents issued by the Auditing Organization state compliance with applicable US regulations, which may provide a marketing advantage.
Canada: Health Canada will operate the current Canadian Medical Device Conformity Assessment System (CMDCAS) program and the MDSAP in parallel -. – Health Canada will accept either an MDSAP certificate or a CMDCAS certificate for the purpose of obtaining a new (or maintaining an existing) Class II, III or IV medical device license, pursuant to section 32 of the Regulations. Additionally, Health Canada’s intent is to implement the Medical Device Single Audit Program as the mechanism to assess regulatory compliance for quality management system requirements in Canada.
After successful completion of the initial audit, CDM Center of Excellence Ltd. have got – issued certification documents including a reference to the MDSAP which state compliance to ISO 13485: and the applicable Medical Device Regulations from each jurisdiction that were used as audit criteria.
CDM Center Of Excellence Ltd. is very happy to have managed the MSDAP and be able to offer our clients and customers again another one step forward in international certification for smooth and extended business relations.