One Audit. Multiple Markets. Global Confidence.
Streamline Medical Device Compliance Across International Markets
Understand how MDSAP brings participating regulatory requirements into one coordinated quality management system audit—helping manufacturers prepare for broader market access with greater confidence.
Build a stronger path to international medical device market access
What Is the Medical Device Single Audit Program?
The Medical Device Single Audit Program (MDSAP) is an international initiative designed to allow a single audit of a medical device manufacturer’s quality management system to satisfy the requirements of multiple participating regulatory authorities. Created to reduce unnecessary audit duplication while strengthening regulatory oversight, MDSAP uses a standardized audit model based on ISO 13485 and applicable jurisdiction-specific requirements. An authorized MDSAP Auditing Organization evaluates key processes—from management responsibility and measurement to design, purchasing, production, and post-market activities—through one coordinated audit. For manufacturers, this creates a more efficient, consistent approach to demonstrating quality system compliance and preparing for access to participating markets, including Canada, Australia, Brazil, Japan, and the United States.
Reduce Audit Duplication and Operational Burden
Instead of managing separate inspections and overlapping requests across jurisdictions, eligible manufacturers can prepare for one comprehensive MDSAP audit. The program creates a structured way to address common quality management system expectations, reduce repetitive audit activity, and focus internal resources on maintaining effective processes, product quality, and patient safety. A well-prepared MDSAP program can make audit planning more predictable and help teams coordinate evidence, corrective actions, and ongoing compliance activities more efficiently.
Demonstrate Consistent Compliance With Confidence
MDSAP provides regulators and manufacturers with a consistent, process-based view of quality system performance. Its standardized audit approach helps identify how effectively your organization manages risks, controls outsourced processes, handles complaints, conducts CAPA, and monitors products after market release. Whether you are beginning MDSAP readiness work, transitioning from ISO 13485 certification, or maintaining an established program, a disciplined approach supports stronger compliance decisions and builds confidence among regulators, customers, and global market partners.
Regulatory Authorities Recognizing MDSAP Audit Outcomes
A practical path from readiness assessment to ongoing certification
Your MDSAP Lifecycle, Step by Step
1
Confirm Your Market Requirements
Identify the jurisdictions you serve and map the applicable MDSAP requirements, including ISO 13485 and relevant regulatory processes for participating authorities.
2
Select an Authorized Auditing Organization
Choose an MDSAP-recognized auditing organization, define your audit scope, and prepare a coordinated plan for document review and on-site assessment.
3
Audit, Corrective Action & Certification
Complete the MDSAP audit, address any nonconformities within agreed timelines, and maintain certification through annual surveillance and recertification audits.
One Coordinated Audit for Multiple Regulatory Markets
Compare the operational burden of separate country audits with the integrated MDSAP approach for eligible medical device manufacturers.
Traditional Individual Regulatory Audits
Separate audit schedules by market
Multiple assessments of similar QMS processes
Country-specific audit reports and follow-up
Repeated preparation for each authority
Market access managed jurisdiction by jurisdiction
Higher coordination demands across audit cycles
MDSAP Approach
One audit cycle coordinated through an authorized auditing organization
Single integrated assessment against MDSAP audit model requirements
Audit outcomes recognized or used by participating regulators according to their policies
One structured preparation program supporting multiple participating markets
Supports international access planning for Canada, the United States, Brazil, Australia and Japan
Ongoing surveillance creates a consistent, scalable compliance rhythm
Build and Sustain MDSAP Readiness
Understand Your Starting Point
Learn how MDSAP applies to your products, target markets, quality management system, and regulatory responsibilities before setting a readiness plan.
Assess, Close Gaps, and Implement
Compare your existing ISO 13485 processes against MDSAP audit requirements, prioritize gaps, and embed effective controls across the QMS.
Prepare for Audit and Ongoing Performance
Validate readiness through internal audits, management review, evidence preparation, and corrective action processes that support continual compliance.
MDSAP Audit Focus Areas
Management Responsibility and Improvement
Demonstrate leadership oversight, quality objectives, management review, internal auditing, CAPA, complaint handling, and data-driven improvement.
Product Realization and Risk Management
Align design, purchasing, production, servicing, validation, and risk management activities with documented controls and objective evidence.
Regulatory Controls Across Markets
Understand how MDSAP evaluates regulatory reporting, adverse event processes, licensing obligations, and market-specific requirements for participating authorities.
Frequently Asked Questions About MDSAP
Get clear answers to common questions about program participation, audit expectations, certification, and the role of MDSAP in international market access.
Who can participate in MDSAP?
MDSAP is available to medical device manufacturers with an ISO 13485-based quality management system, including organizations seeking or maintaining access to participating markets. Participation may be mandatory or voluntary depending on the jurisdiction and product activity.
Which regulatory authorities participate in MDSAP?
Participating authorities include Health Canada, the U.S. Food and Drug Administration, Brazil’s ANVISA, Japan’s PMDA and MHLW, and Australia’s Therapeutic Goods Administration. Audit outcomes may be used differently by each authority.
Does an MDSAP audit replace all other regulatory obligations?
No. An MDSAP audit can support oversight across participating jurisdictions, but manufacturers must still meet applicable registration, licensing, product-specific, reporting, labeling, and post-market requirements in every market where they operate.
