RegAQs - Frequently Asked Questions on the MDSAP process. 

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: · 1. MDSAP routine audits are announced, scheduled by the Auditing Organization with the manufacturer, with a pre-established duration; 2. 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; · 3. 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); 4. Certification documents issued by the Auditing Organization state compliance with applicable US regulations, which may provide a marketing advantage. Note: Inspections conducted “For Cause” or “Compliance Follow-up” by FDA will not be affected by this program. Moreover, this MDSAP program would not apply to any necessary pre-approval or post approval inspections for Premarket Approval (PMA) applications or to decisions under section 513(f)(5) of the Act (21 U.S.C. 360c(f)(5)) concerning the classification of a device. Brazil The Brazilian National Health Surveillance Agency - ANVISA utilizes the outcomes of the MDSAP program, including the reports, to constitute an important input on ANVISA’s pre-market and post-market assessment procedures, providing, when applicable, key information that are expected to support regulatory technical evaluation on these issues. As defined in 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. Some participating regulatory authorities will use MDSAP audit outcomes as an alternative to their own inspections to process applications for medical device marketing authorization.