At EUmAccess GmbH, we assist medical device manufacturers in obtaining certification under the Medical Device Single Audit Program (MDSAP), enabling them to comply with regulatory requirements across multiple countries through a single audit process.
What is MDSAP?
The Medical Device Single Audit Program (MDSAP) allows manufacturers to undergo one regulatory audit to satisfy the requirements of multiple participating countries. This reduces the burden of multiple audits and streamlines compliance.
MDSAP Participating Regulatory Authorities:
United States – FDA (Food and Drug Administration)
Canada – Health Canada
Australia – TGA (Therapeutic Goods Administration)
Brazil – ANVISA (Agência Nacional de Vigilância Sanitária)
Japan – MHLW/PMDA (Ministry of Health, Labour and Welfare / Pharmaceuticals and Medical Devices Agency)
Mandatory in Canada – Since January 1, 2019, Health Canada requires all Class II, III, and IV medical devices to be certified under MDSAP.
Benefits of MDSAP Certification
Single Audit for Multiple Markets – Reduces the need for multiple audits, saving time and costs
Improved Global Market Access – Ensures compliance with major regulatory authorities
Enhanced Regulatory Oversight – Strengthens quality management system (QMS) compliance
Risk-Based Approach – Focuses on patient safety and regulatory efficiency
Competitive Advantage – Demonstrates high-quality standards to regulators and stakeholders
Our MDSAP Services
MDSAP Readiness Assessment & Gap Analysis
- Evaluating existing ISO 13485:2016 QMS compliance with MDSAP requirements
- Identifying gaps and recommending improvements
MDSAP Implementation & Documentation Support
- Aligning QMS with MDSAP regulatory requirements
- Developing procedures, policies, and documentation for compliance
Internal Audits & Pre-Certification Support
- Conducting internal audits to prepare for the official MDSAP audit
- Assisting with audit preparation and corrective actions
Training & Regulatory Guidance
- Training teams on MDSAP requirements, regulatory expectations, and audit preparedness
Who Needs MDSAP Certification?
Medical Device Manufacturers targeting MDSAP-participating countries
Contract Manufacturers & Suppliers
Distributors & Regulatory Consultants
Drop here a note
contact@eumaccess.com
Call us Directly
+49 621-76-44-10-101
Drop here a note
contact@eumaccess.com
Call us Directly
+49 621-76-44-10-101
EUmAccess GmbH
At EUmAccess GmbH, we specialize in providing expert regulatory and compliance solutions to businesses with a focus on the Medical Devices (MD) and In Vitro Diagnostic (IVD) sectors, we assist manufacturers in navigating the complex regulatory landscape, ensuring smooth market entry and compliance with EU directives and regulations.