Brazil Technical Dossier Pack
€249.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
For Class III and IV devices, ANVISA requires a full technical dossier. This pack gives you that dossier as a set of structured, fill-in Word templates organised on the IMDRF table of contents — the internationally recognised structure ANVISA aligns with.
Rather than a blank page, you get a professionally laid-out skeleton with guidance notes, bracketed prompts and evidence tables, ready to be completed for your device.
What’s inside
Eight files — a README, six dossier chapters and a master index:
- BR-TF-00 README — how the pack is structured and how to complete it.
- Chapter templates (01–06) — device description; design and manufacturing; essential requirements; risk management; verification and validation; clinical and post-market.
- Master Index (Excel) — a control sheet tracking every document, its status and revision.
- Guidance and evidence tables throughout, with bracketed prompts to replace and delete before submission.
Why it works
- Straight from the regulations. Every item is traced to the regulation, annex or guidance it comes from — not a second-hand summary.
- Structured on the IMDRF ToC. Follows the internationally recognised table of contents ANVISA aligns with, so the dossier reads the way a reviewer expects.
- Built to be completed. Colour-coded fill-in fields, dropdowns and a clean print layout — designed to be worked in, not just read.
- Consistent and controlled. Headers, footers, document codes and a master index keep a multi-file dossier coherent and audit-ready.
How to use it
- Start from the README to understand the structure and document codes.
- Complete each chapter template against your device, replacing the bracketed prompts.
- Track status and revisions in the master index.
- Delete the guidance notes and assemble the dossier for your BRH to submit.
Who it’s for
- Manufacturers of Class III/IV devices preparing a full ANVISA registration
- RA consultants who want a submission-ready dossier skeleton
- Teams standardising how their technical files are structured
Specifications
Frequently asked questions
Are these editable Word files?
Yes — fully editable .docx templates you complete for your device, plus an Excel master index.
Why the IMDRF table of contents?
It is the internationally recognised dossier structure ANVISA aligns with, so the file reads the way a reviewer expects.
Does it include the essential requirements?
It includes an essential-requirements chapter; for the full RDC 848/2024 checklist with GSPR mapping, add the Essential Requirements Checklist or the Gold Kit.
€249.00
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