The Seven MDSAP Audit Processes
A Manufacturer's Guide to Compliance and Audit Readiness
Overview of the Process-Based Audit Model
The Medical Device Single Audit Program (MDSAP) lets one audit by a recognized Auditing Organization satisfy regulators in Australia, Brazil, Canada, Japan and the United States. Health Canada requires it for Class II to IV device licences. FDA accepts MDSAP reports in place of routine surveillance inspections, though not for-cause or pre-approval inspections. JJCC Group prepares you to pass the first time.
The Seven Processes at a Glance
| # | Process | Scope and Key Focus |
|---|---|---|
| 1 | Management | Leadership commitment, quality policy and objectives, resource allocation, management review, communication. Audited every cycle. |
| 2 | Measurement, Analysis & Improvement | Internal audits, CAPA, data analysis, monitoring of customer feedback and complaints, statistical techniques. Audited every cycle. |
| 3 | Medical device adverse events and advisory notices reporting | Country-specific vigilance reporting timelines, field safety corrective actions (FSCA), and recall procedures for all five jurisdictions. |
| 4 | Design & Development | Design controls including planning, inputs, outputs, V&V, design transfer, design changes, and the Design History File (DHF). |
| 5 | Production & Service Controls | Process validation (IQ/OQ/PQ), environmental controls, sterilization, traceability, identification, servicing, and installation. |
| 6 | Purchasing | Supplier qualification and re-evaluation, purchasing data, verification of purchased product, and supplier risk management. |
| 7 | Device Marketing Authorization & Facility Registration | Country-specific licenses, registrations, listings, UDI submissions, and authorized representative arrangements. |
Country-Specific Compliance Guidance
Australia (TGA):
Align with Therapeutic Goods (Medical Devices) Regulations 2002, Schedule 3. Maintain an Australian Sponsor and ensure ARTG inclusion. Report adverse events within 48 hours to 30 days based on severity
Brazil (ANVISA)
Comply with RDC 665/2022 (GMP) and RDC 67/2009 (technovigilance). Hold a Brazilian Registration Holder (BRH) and submit Technovigilance Reports for serious events within 72 hours.
Canada (Health Canada)
MDSAP is mandatory for Class II–IV device licenses under SOR/98-282. Mandatory Problem Reporting required within 10 days (serious) or 30 days (non-serious). Maintain a Canadian Medical Device License (MDL).
Japan (MHLW/PMDA)
Meet MHLW Ministerial Ordinance No. 169 requirements. Appoint a Marketing Authorization Holder (MAH/D-MAH) and report malfunctions within 15 to 30 days under the PMD Act.
United States (FDA)
Comply with 21 CFR Part 820 (QSR) — transitioning to QMSR alignment with ISO 13485 effective February 2026. File MDRs within 30 days (or 5 days for events requiring remedial action).
How MDSAP differs from an ISO 13485 audit
MDSAP follows a set audit sequence and adds each participating country’s regulatory requirements. Nonconformities are graded 1 to 5, and grades 4 and 5 are reported to the regulators. Your system must meet ISO 13485 plus every country rule for the markets you sell in.
Engagement Structure
- Pre-Audit Readiness Assessment (Week 1): Readiness assessment and document review
- On-Site Mock Audit (Weeks 2–3): On-site mock audit, following the MDSAP audit sequence
- Findings Report & Grading (Week 4): Graded report, using the MDSAP 1–5 scale
- Remediation Roadmap & CAPA Coaching (Weeks 5–8): Remediation and CAPA coaching
- Final Readiness Verification (Weeks 9+): Verification before your Stage 2 audit
Deliverables: a graded findings report, process-linkage matrix, CAPA tracker, audit-day playbook, and an executive readiness scorecard. JJCC Group Services guarantees that clients completing the full program enter their certification audit with documented evidence of process maturity across all seven MDSAP processes and clear ownership of every country-specific obligation.
Testimonial
What our clients say about JJCC
Professional, knowledgeable team guided us through FDA registration and complete product listing accurately and efficiently.
MDSAP Audit Process: Frequently Asked Questions
How JJCC Group Services Helps Medical Device Manufacturers Achieve and Maintain Certification
The Medical Device Single Audit Program (MDSAP) is one of the most consequential quality system audits a medical device manufacturer can undertake. The questions below address the issues most frequently raised by clients preparing for, undergoing, or maintaining MDSAP certification, and explain how JJCC Group Services supports manufacturers at every stage of the journey.
Ready to start your MDSAP journey?
Contact JJCC Group Services to schedule a complimentary readiness consultation. Our team will assess your current MDSAP posture and recommend the right combination of gap analysis, remediation, and mock audit services to achieve certification with confidence.
