MDSAP - Medical Device Single Audit Program
What is the Medical Device Single Audit Program (MDSAP)?
The Medical Device Single Audit
Program (MDSAP) is a harmonised approach to auditing and monitoring the quality
management systems of medical device manufacturers on an international scale.
It was developed by a group of medical device regulators (the IMDRF) to recognise
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
MDSAP Auditing Organisation (AO).
The program allows medical device manufacturers to get an efficient, single audit from an authorised Auditing Organisation (AO) under Medical Device Single Audit Program and satisfy certain compliance requirements (such as ISO 13485) of the participating regulatory authorities. Accordingly, Medical Device Single Audit Program audit reports may be used by regulatory authorities in lieu of their own inspection reports. The current program 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 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.”
|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 will use 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 MDSAP 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.
Why choose Intertek?
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.
With more than 20 years of global experience as a Registrar and Notified Body, Intertek is the choice of more than half of the world’s top 200 companies.
Partner with us and gain the confidence of knowing you have a solid quality management system in place for medical devices.
What to expect from a MDSAP audit
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