MDSAP Documentation Kit — 15 SOPs + 18 Templates for All 5 Jurisdictions (BR · JP · CA · AU · USA)

MDSAP Documentation Kit — Complete

The flagship kit. Everything your QMS needs to face an MDSAP audit confidently across all 5 jurisdictions: Brazil, Japan, Canada, Australia, USA. 15 procedures + 18 templates + a User Guide and Master Index, all aligned to the latest 2025-2026 regulatory frameworks.

What’s included:

Shared Core (4 procedures + 8 templates) — the QMS backbone reusable also for ISO 13485:

• SOP-CORE-01 Document and Record Control + 3 templates
• SOP-CORE-02 Management Review + 1 template
• SOP-CORE-03 Internal Audit + 3 templates
• SOP-CORE-04 CAPA + 1 comprehensive template

MDSAP Manifesto:

• SOP-MDSAP-00 MDSAP Program Management

Marketing Authorization (5 jurisdictions):

• SOP-REG-BR Brazil (ANVISA RDC 751/2022) + Classification + Pathway template
• SOP-REG-JP Japan (PMDA, Shonin/Ninsho/Todokede) + JMDN + Pathway template
• SOP-REG-CA Canada (Health Canada MDL/MDEL) + Classification + MDL Checklist
• SOP-REG-AU Australia (TGA ARTG) + Conformity Assessment Pathway template
• SOP-REG-US USA (FDA 510(k)/De Novo/PMA) + Pathway + SE Matrix (Excel)

Vigilance Reporting (5 jurisdictions):

• SOP-VIG-BR Brazil (Notivisa, RDC 67/2009) + Reportability worksheet
• SOP-VIG-JP Japan (PMD Act, LISTED/UNLISTED logic) + Reportability worksheet
• SOP-VIG-CA Canada (MPR §59 + FRN §61.2) + combined worksheet
• SOP-VIG-AU Australia (MDIR + PRAC + exemption framework) + Exemption worksheet
• SOP-VIG-US USA (FDA MDR 21 CFR 803) + MDR Reportability worksheet

Plus: Quick Start User Guide and a comprehensive Master Index spreadsheet cataloguing all documents across the kit.

Why this kit: Buying the 15 packages individually would cost €1,035. Save more than 60% with the complete kit. Plus the User Guide and Master Index that aren’t available separately — together they make onboarding faster and cross-references reliable.

Updated: May 2026 — reflects FDA QMSR (Feb 2026), MDSAP P0002.010, ANVISA RDC 591/2021 UDI, AusUDID, PRAC, and other current regulatory frameworks.

Format: Microsoft Word + Microsoft Excel (fully editable)
Delivery: Instant download — single ZIP with structured folder hierarchy