The Medical Device Single Audit Program (MDSAP) allows the conduct of a single regulatory audit of a medical device manufacturer’s quality management systems, which also satisfies the requirements of multiple regulatory jurisdictions. These jurisdictions currently include the US (FDA), Japan (MHLW/PMDA), Canada (Health Canada), Brazil (ANVISA) and Australia (TGA).
MDSAP certification allows medical device manufacturers to be audited for compliance with the ISO 13485 standard and regulatory requirements across these markets. The mission is to “jointly leverage regulatory resources to manage efficient, effective, and sustainable single audit program focused on the oversight of medical device manufacturers.” This enables appropriate regulatory oversight of medical manufacturers’ quality systems, as well as promotes alignment of regulatory approaches and technical requirements based off of ISO 13485 best practices.
Any manufacturer of medical devices is eligible to undergo an assessment under the MDSAP standard, however dependent on the regulatory authority, exclusion criteria may apply. In lieu of multiple audits or inspections, the program reduces the overall number of assessments and optimizes time and resources spent on those activities.
Such benefits include:
“The TGA will take into account MDSAP audit reports when considering whether to issue or maintain a TGA Conformity Assessment Certificate. Under some circumstances a manufacturer may avoid routine TGA inspections. TGA will take into account MDSAP- audit reports when considering whether a manufacturer has demonstrated compliance with an Australian Conformity Assessment procedure.”
“RDC 15/2014 and RE 2.347/2015, ANVISA may use MDSAP audits in lieu of a premarket inspection by ANVISA to grant ANVISA’s GMP Certificate to manufacturers intending to put medical devices of class III or IV on the Brazilian market. Undergoing an MDSAP audit may accelerate ANVISA´s GMP certification process, which is a pre-requisite to the marketing authorization. ANVISA can also use MDSAP audits to renew ANVISA’s GMP Certificate biannually, as an alternative to an ANVISA comprehensive inspection.”
“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.”
“When an MDSAP audit report is submitted at the timing of premarket or periodical post-market QMS inspection application, Japan’s Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) will use the report as a trial: 1) To exempt a manufacturing site etc.* from on-site inspection, and/or to allow a Marketing Authorization Holder (MAH) to substitute considerable part of documents required for the inspection with the report.”
“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).”
Reference- www.fda.gov Q&A Version 016 2017-08-22
In partnership with DQS MED, DQS Inc. is authorized to provide services for MDSAP, MDD (CE marking of medical devices) and ISO 15378.
Contact us at [email protected] for more information