MDSAP - Medical Device Single Audit Program
What is the Medical Device Single Audit Program (MDSAP)?
The Medical Device Single Audit Program (MDSAP) was developed by a group of medical device regulators, the International Medical Device Regulators Forum (IMDRF), to allow third-party auditors to conduct a single audit of a medical device manufacturer that will cover ISO 13485:2016 and their respective regulatory requirements.
Intertek is a recognised Medical Device Single Audit Program Auditing Organisation (AO). Medical Device Single Audit Progam participants include: USA, Canada, Australia, Japan and Brazil.
Regulatory Authorities Participating in MDSAP
|United States of America - FDA|
U.S. Food and Drug Administration’s Center for Devices and Radiological Health – FDA will accept the MDSAP audit reports as a substitute for FDA routine inspections. Inspections conducted “For Cause” or “Compliance Follow-up” by FDA will not be affected by this program. Moreover, this 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.”
|Canada - Health Canada|
Health Canada has recognised the Medical Device Single Audit Program as the means to fulfil the quality management system requirements of the CMDR.
|Australia - TGA|
The Therapeutics Goods Administration - TGA uses a Medical Device Single Audit Program audit report as part of the evidence that is assessed for compliance with medical device market authorisation requirements unless the medical device is otherwise excluded or exempt from these requirements or if current policies restrict the use of Medical Device Single Audit Program audit reports.
|Japan - MHLW & PMDA|
MHLW and PMDA will utilise these audit reports in both premarket and periodical post market audit under regulations in Japan. Medical Device Single Audit Program audits are expected to reduce some burden on Japanese regulatory processes.
|Brazil - ANVISA|
The Brazilian National Health Surveillance Agency – ANVISA will utilise the outcomes of the 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.
What are the benefits of MDSAP certification?
- Reduces the number of audits and inspections a manufacturer must undergo.
- Efficient, single audit scheme minimises business disruptions, reduces costs and saves time.
- Expedites entrance into some markets where traditional regulatory oversight can cause significant delays.
- Consistency of multiple, international regulatory programs by participating regulators.
Intertek participated in the initial pilot phase of the Medical Device Single Audit Program which began in January 2014 and is recognised as an authorised Auditing Organisation. We have trained auditors with exceptional technical expertise and experience in the program. They are industry and sector specifically qualified and conduct professional, effective and competent assessment of your systems.
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