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Medical Device Single Audit (MDSAP)
Meeting Global Compliance Requirements for Medical Device Manufacturers
The Medical Device Single Audit Program (MDSAP) is an international initiative that allows a recognized Auditing Organization to perform a single regulatory audit of a medical device manufacturer, fulfilling the applicable requirements of the participating regulatory authorities. A key benefit of the MDSAP is its ability to reduce the number of audits and inspections conducted by individual regulatory authorities across different target markets.
The MDSAP program standardizes how audits are performed on medical devices across countries. DEKRA, as an independent and recognized Auditing Organization under the Medical Device Single Audit Program (MDSAP), is well-positioned to provide these services.
Why Choose DEKRA for Auditing Medical Devices?
As a leader in medical device auditing, DEKRA offers expert-driven auditing services aligned with MDSAP standards across multiple jurisdictions. Here’s why DEKRA is a trusted choice for MDSAP audits:
- Global Recognition & Expertise – DEKRA is recognized globally by regulatory authorities in key markets. Our auditors are experienced in working with the regulatory frameworks in Australia, Brazil, Canada, Japan, and the USA.
- Comprehensive MDSAP Audits– DEKRA conducts MDSAP audits that meet the regulatory requirements of multiple authorities, including:Australia: The Therapeutics Goods Administration (TGA) will use an MDSAP audit report as part of the evidence to support compliance with the Australian Conformity Assessment procedure for medical devicesBrazil: The Brazilian National Health Surveillance Agency (ANVISA) will utilize the outcomes of the program, including the reports, to constitute important input into ANVISA’s pre-market and post-market assessmentCanada: Health Canada will use an MDSAP audit and associated MDSAP certification to support medical device licensing for manufacturers intending to sell medical devices in CanadaUSA: The USA’s Food and Drug Administration (FDA) will accept the MDSAP audit reports as a substitute for FDA routine inspectionsJapan: Japan’s Ministry of Health, Labor and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) will use the MDSAP audit report to, e.g., exempt from inspections and substitute documents
- Extensive Experience – DEKRA’s experts possess in-depth knowledge and extensive experience with the MDSAP requirements set by the participating Regulatory Authorities. We conduct MDSAP audits and keep our customers informed about important developments related to the program.
- Trusted by Leading Manufacturers – DEKRA has a proven track record of conducting MDSAP audits for medical device manufacturers worldwide. Our clients rely on us for thorough, audits that meet the expectations of regulatory authorities across multiple regions.
MDSAP Benefits for Medical Device Manufacturers
Participating in the MDSAP program offers the following benefits:
- Efficient Auditing Process: It enables a medical device manufacturer to undergo a single quality management system audit that meets the requirements of all participating regulatory authorities.
- Access to Global Markets: MDSAP audits are accepted by regulatory authorities such as FDA, ANVISA, Health Canada, TGA, and PMDA, supporting market access in multiple regions.
- The goal: is to streamline regulatory oversight by leveraging shared resources to create an efficient, sustainable single audit program, enhancing medical device safety while reducing industry burdens.
DEKRA’s MDSAP Auditing Services
DEKRA provides MDSAP auditing services for medical device manufacturers. Our audit teams are trained in the regulatory requirements for each participating jurisdiction. We conduct a focused Quality Management System audit to verify that your device meets the necessary MDSAP standards in the relevant markets.
Ready to Proceed With Your MDSAP Audit?
Contact DEKRA today to schedule your MDSAP audit and verify that your medical device meets global regulatory standards. With DEKRA, you can expect efficient, impartial, and audit-only services that are accepted worldwide. Contact us today!