While the Medical Device Single Audit Program (MDSAP) is still being piloted, it is crucial for medical device manufacturers to understand the potential benefits and implications of an international single audit program.
There are many advantages to an MDSAP for both the medical device manufacturer and regulatory authorities.
Developed by the International Medical Device Regulators Forum (IMDRF), the MDSAP is still being evaluated to determine feasibility and the effectiveness of a single quality audit.
When fully implemented, the MDSAP has the potential to greatly impact the medical device quality auditing environment.
Let's start with the basics:
What is the Medical Device Single Audit Pilot?
The Medical Device Single Audit Program (MDSAP) Pilot is a program that was developed by the International Medical Device Regulators Forum (IMDRF).
The pilot program is designed to evaluate the feasibility of a single audit program that will satisfy the relevant requirements of the medical device regulatory authorities participating in the pilot program.
Per the IMDRF MDSAP, International Coalition Pilot Program Sheet, Jan 2014, the program will jointly leverage regulatory resources to manage an efficient, effective, and sustainable single audit program focused on the oversight of medical device manufacturers.
How long will the pilot program run?
The pilot program is planned to run from January 2014 through December 2016, to confirm proof of concept. The full implementation of the single audit program should occur sometime in 2017.
The MDSAP is based on the use of third-party auditors that conduct quality and compliance audits using the guidelines and regulations established by regulatory authorities.
The MDSAP is designed to allow medical device manufacturers to undergo a single audit by an authorized auditing organization that will satisfy the relevant requirements of the regulatory authorities participating in the pilot program.
The MDSAP Pilot includes representatives from:
- Australian Therapeutic Goods Administration (TGA)
- Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA)
- Health Canada
- U.S. Food and Drug Administration (FDA)
- Japan’s Ministry of Health, Labour and Welfare (MHLW) with Pharmaceuticals and Medical Devices Agency (PMDA) (observer)
What is the MDSAP's mission?
The mission of the MDSAP is to leverage regulatory resources from multiple regions to manage an effective, efficient, and sustainable single audit program focused on the oversight of medical device manufacturers.
The MDSAP model was designed following the approach in FDA’s Quality System Inspection Technique document, using a top-down approach.
The MDSAP also includes requirements from ISO 13485:2003 Medical Devices – Quality Management Systems – Requirements for regulatory purposes, the Brazilian Good Manufacturing Practices (RDC ANVISA 16/2013), FDA’s Quality System Regulation (21 CFR 820), and other registration, licensing, advisory notice, recall and adverse event reporting requirements from participating regulatory authorities.
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