MDSAP Certification
One Audit, Five Markets
Streamline your global regulatory compliance with a single MDSAP audit covering Health Canada, US FDA, ANVISA Brazil, TGA Australia, and PMDA Japan. NexorTest guides you from QMS gap analysis through successful certification.
Five Regulatory Authorities, One Audit
MDSAP enables a single QMS audit to satisfy the requirements of five participating regulatory authorities simultaneously, eliminating redundant audits and reducing compliance costs.
Health Canada
MDSAP Required Since 2019. MDSAP replaced CMDCAS as the mandatory QMS audit pathway for medical devices entering the Canadian market.
- Mandatory
- Class II-IV
- MDEL Required
Why is MDSAP mandatory for Canada?
MDSAP is mandatory for all Class II, III, and IV medical devices sold in Canada since January 1, 2019, replacing CMDCAS.
US FDA
Substitutes for FDA Inspection. MDSAP audits conducted by FDA-recognized AOs can substitute for routine FDA facility inspections.
- Voluntary
- 21 CFR 820
- QMSR
How does MDSAP relate to FDA inspections?
MDSAP audits can substitute for FDA facility inspections. FDA-recognized AOs conduct audits covering 21 CFR 820 requirements.
ANVISA Brazil
GMP Compliance. ANVISA accepts MDSAP audit reports as evidence of Good Manufacturing Practice compliance for medical devices.
- Accepted
- RDC 665
- INMETRO
How does ANVISA use MDSAP reports?
ANVISA accepts MDSAP audit reports for demonstrating Good Manufacturing Practice compliance for medical devices in Brazil.
TGA Australia
Conformity Assessment. TGA accepts MDSAP certificates as evidence of QMS conformity for medical devices seeking ARTG inclusion.
- Accepted
- ARTG
- Therapeutic Goods Act
Does TGA accept MDSAP certificates?
TGA accepts MDSAP certificates as evidence of QMS conformity for medical devices seeking ARTG inclusion in Australia.
PMDA Japan
QMS Compliance. Japan’s PMDA/MHLW accepts MDSAP reports for QMS compliance verification under the PMD Act.
- Accepted
- MHLW
- PMD Act
How does Japan use MDSAP?
Japan’s PMDA/MHLW accepts MDSAP reports for QMS compliance verification under the Pharmaceutical and Medical Device Act.
Comprehensive MDSAP Certification Services
From initial gap analysis through post-certification maintenance, NexorTest manages every aspect of your MDSAP certification journey.
MDSAP Initial Certification
Complete preparation and support for your first MDSAP certification audit. Includes QMS readiness assessment, ocumentation review, mock audits, AO coordination, and on-site audit support to ensure a uccessful first-time certification.
MDSAP Surveillance & Recertification Audits
Ongoing support for annual surveillance audits and 3-year recertification cycles. We prepare your team, review QMS updates, address previous nonconformities, and provide on-site support throughout each audit engagement.
ISO 13485:2016 QMS Implementation
Full implementation of the ISO 13485:2016 Quality Management System that forms the foundation of MDSAP certification. Gap analysis, process mapping, documentation development, training, internal audits, and certification body coordination.
QMS Gap Analysis & Readiness Assessment
Comprehensive assessment of your existing QMS against MDSAP requirements for all target participating countries. Detailed gap report with prioritized remediation roadmap, resource estimates, and timeline to certification readiness.
Auditing Organization (AO) Selection & Coordination
Expert guidance in selecting the optimal MDSAP-recognized Auditing Organization based on your device scope, geographic needs, and budget. We manage the entire AO engagement process from initial contact through audit scheduling.
Nonconformity Resolution & CAPA Management
Expert support for addressing MDSAP audit nonconformities (Grade 1 through Grade 5). Root cause analysis, CAPA development and implementation, evidence compilation, and timely response submission within the 30-day critical finding deadline.
Country-Specific Companion Document Compliance
Detailed compliance mapping against MDSAP companion documents for each participating authority. Ensures your QMS addresses the specific regulatory requirements of Health Canada, FDA, ANVISA, TGA, and PMDA beyond core ISO 13485.
MDSAP Documentation & SOP Development
Development and optimization of all QMS documentation required for MDSAP certification. Quality manual, standard operating procedures, work instructions, forms, templates, and records aligned with all seven MDSAP audit process areas.
Post-Certification Maintenance & Continuous Improvement
Ongoing support to maintain your MDSAP certificate between audits. Includes regulatory change monitoring, QMS continuous improvement, management review facilitation, internal audit programs, and surveillance audit preparation.
Your Trusted MDSAP Specialist
We combine multi-jurisdiction regulatory expertise with hands-on audit experience to deliver faster, more predictable MDSAP certifications.
Multi-Jurisdiction QMS Expertise
Deep understanding of all five MDSAP regulatory frameworks — Health Canada SOR/98-282, FDA 21 CFR 820/QMSR, ANVISA RDC 665, TGA Therapeutic Goods Act, and PMDA PMD Act — ensuring your QMS satisfies every participating authority.
Design + Testing + Certification Under One Roof
Integrated services covering regulatory design review, safety and performance testing at our accredited labs, and complete MDSAP certification support — eliminating multi-vendor complexity and coordination overhead.
AO Relationship Network
Established relationships with all major MDSAP Auditing Organizations including BSI, SGS, TUV, DEKRA, Intertek, and others. We help you select the right AO and facilitate seamless audit coordination.
Multi-Region Expertise — 30+ Countries
Register your medical device in 30+ countries from a single partner. Leverage MDSAP certification alongside EU MDR, UK UKCA, Saudi SFDA, India CDSCO, and other regulatory pathways for comprehensive global market access.
Transparent Pricing & Fixed-Fee Packages
No hidden costs or hourly billing surprises. Our fixed-fee packages cover the complete scope from gap analysis through certification and ongoing maintenance, with clear milestones and deliverables at every stage.
Six Steps to Your MDSAP Certificate
A proven, structured approach that maximizes first-audit pass rates and delivers predictable certification outcomes across all five markets.
QMS Gap Analysis & Regulatory Strategy
We conduct a comprehensive gap analysis of your existing QMS against ISO 13485:2016 and MDSAP requirements for all target participating countries, delivering a prioritized remediation roadmap with clear timelines and resource estimates.
ISO 13485 Implementation & Documentation
Our team implements or optimizes your ISO 13485:2016 Quality Management System, developing all required documentation including quality manual, SOPs, work instructions, and records aligned with the seven MDSAP audit process areas.
Country-Specific Companion Document Preparation
We prepare your QMS for country-specific requirements defined in MDSAP companion documents: Health Canada SOR/98-282, FDA 21 CFR 820/QMSR, ANVISA RDC 665, TGA Therapeutic Goods Act, and PMDA PMD Act requirements.
Auditing Organization Selection & Scheduling
We help you select the optimal MDSAP-recognized Auditing Organization from 16+ recognized AOs based on your device scope, geographic location, scheduling needs, and budget. We coordinate all audit logistics and pre-audit documentation.
MDSAP Audit Support & Nonconformity Resolution
We provide on-site support during your MDSAP audit. If nonconformities are identified, we manage root cause analysis, CAPA development, evidence compilation, and timely response submission within the 30-day critical finding deadline.
Certification Maintenance & Surveillance Audit Support
After certification, we provide ongoing support including regulatory change monitoring, QMS continuous improvement, management review facilitation, internal audit programs, and preparation for annual surveillance and recertification audits.
MDSAP Certification Across All Device Sectors
NexorTest supports medical device manufacturers across every therapeutic area and technology vertical pursuing MDSAP certification.
- 🏥 Cardiovascular Devices
- 🦴 Orthopaedic Implants
- 🔬 In Vitro Diagnostics (IVD)
- 💻 Software as Medical Device (SaMD)
- 🧬 Dental Devices
- 👁 Ophthalmic Devices
- 🩺 Patient Monitoring Systems
- 💉 Drug Delivery Devices
- 🧠 Neurological Devices
- ❤ Wound Care Products
- 🏋 Rehabilitation Equipment
- 💡 AI/ML-Based Medical Devices
- 🩸 Blood Bank Equipment
- 📊 Imaging & Radiology Devices
- 🧪 Laboratory Instruments
- 🛡 Sterilization Equipment
MDSAP Certification FAQ
Expert answers to the most common questions about the Medical Device Single Audit Program and MDSAP certification.
What is MDSAP?
MDSAP (Medical Device Single Audit Program) is an international program managed by the International Medical Device Regulators Forum (IMDRF) that allows a single quality management system (QMS) audit of a medical device manufacturer to satisfy the requirements of five participating regulatory authorities simultaneously: Health Canada, US FDA, ANVISA (Brazil), TGA (Australia), and PMDA/MHLW (Japan). Instead of undergoing separate regulatory audits for each market, manufacturers engage an MDSAP-recognized Auditing Organization (AO) to conduct one comprehensive audit covering ISO 13485:2016 and country-specific regulatory requirements. The program reduces audit burden, lowers costs, and provides predictable 3-year certification cycles.
Is MDSAP mandatory?
MDSAP is mandatory for Health Canada since January 1, 2019, replacing the former Canadian Medical Devices Conformity Assessment System (CMDCAS). All manufacturers of Class II, III, and IV medical devices sold in Canada must hold a valid MDSAP certificate. For the other four participating authorities — US FDA, ANVISA (Brazil), TGA (Australia), and PMDA/MHLW (Japan) — MDSAP participation is voluntary but highly beneficial. For FDA, an MDSAP audit can substitute for a routine facility inspection. For ANVISA, TGA, and PMDA, MDSAP certificates are accepted as evidence of QMS compliance, streamlining market access.
What countries participate in MDSAP?
MDSAP has five full participating regulatory authority members: Health Canada (Canada), US FDA (United States), ANVISA (Brazil), TGA (Australia), and PMDA/MHLW (Japan). In addition, there are eight affiliate members as of 2025: Argentina (ANMAT), South Korea (MFDS), Israel (AMAR), Kenya (PPB), Mexico (COFEPRIS), Taiwan (TFDA), South Africa (SAHPRA), and Malaysia (MDA). Affiliate members observe and may adopt MDSAP principles, potentially becoming full members in the future, which would further expand the program’s global reach.
What is the MDSAP audit process?
The MDSAP audit follows a 3-year certification cycle. An initial certification audit is conducted by a recognized Auditing Organization (AO), followed by annual surveillance audits in years two and three, then a recertification audit. The audit uses a process-based methodology covering 7 QMS processes: Management, Device Marketing Authorization and Facility Registration, Measurement Analysis and Improvement, Medical Device Adverse Events and Advisory Notices Reporting, Design and Development, Production and Service Controls, and Purchasing. Nonconformities are graded from Grade 1 (minor) to Grade 5 (critical). Manufacturers have 30 days to respond to critical findings, compared to 15 days for traditional FDA 483 observations.
How much does MDSAP certification cost?
MDSAP certification costs depend on several factors including company size, number of employees, scope of devices manufactured, number of participating countries selected, and the Auditing Organization (AO) chosen. Typical costs include AO audit fees (which vary by AO and audit duration), internal preparation costs, QMS gap remediation expenses, and ongoing surveillance audit fees. While the initial investment may be comparable to or slightly higher than a single ISO 13485 audit, MDSAP delivers significant cost savings by eliminating 3-4 separate regulatory audits that would otherwise be required. NexorTest offers transparent fixed-fee consulting packages. Contact us for a personalized cost assessment.
What are MDSAP auditing organizations?
MDSAP Auditing Organizations (AOs) are independent third-party certification bodies recognized by the MDSAP regulatory authorities to conduct MDSAP audits. There are 16+ recognized AOs worldwide, including BSI Group, DEKRA Certification, DNV Presafe, DQS MED, LNE/GMED, Intertek, SGS, TUV Rheinland, TUV SUD, UL, NSAI, and NCC Certificacoes. AOs must be accredited to ISO/IEC 17021 and undergo regular oversight by the MDSAP regulatory authorities. Choosing the right AO is important as each has different strengths, geographic coverage, scheduling availability, and fee structures.
What is the difference between MDSAP and traditional audits?
Traditional regulatory audits require separate audits for each market — an ISO 13485 certification audit, a Health Canada audit, an FDA inspection, and potentially separate audits for Brazil, Australia, and Japan. MDSAP consolidates these into a single comprehensive audit that satisfies all five participating authorities simultaneously. Key differences include: (1) Single vs. multiple audits — one MDSAP audit replaces 3-4 separate audits. (2) Cost savings — elimination of redundant audit fees, travel costs, and preparation time. (3) Predictable scheduling — fixed 3-year cycle vs. unannounced inspections. (4) Standardized grading — consistent Grade 1-5 system across all authorities. (5) Longer response times — 30 days vs. 15 days for FDA 483 observations.
Can NexorTest help prepare for MDSAP audits?
Yes, NexorTest provides comprehensive MDSAP preparation and support services throughout the entire certification lifecycle. Our services include: QMS gap analysis against MDSAP requirements and all participating country companion documents, ISO 13485:2016 implementation and optimization, documentation and SOP development, mock audits simulating actual MDSAP audit conditions, Auditing Organization selection and coordination, on-site audit support during the actual MDSAP audit, nonconformity resolution and CAPA management, and ongoing post-certification maintenance. With over 300 successful MDSAP certifications and a 98% first-audit pass rate, NexorTest ensures your organization is fully prepared for a successful MDSAP audit outcome.
Ready to Achieve MDSAP Certification?
Get a free MDSAP assessment from our global regulatory experts. We will map your fastest path to certification across all five participating markets.
Expand Your Reach with Multi-Market Access
Leverage NexorTest's global regulatory network to register your medical device in 30+ markets from a single integrated program.
US FDA 510(k)
EU MDR CE Marking
EU IVDR
UK UKCA / MHRA
Saudi SFDA
UAE MoHAP
