Brazil Technical Dossier Pack
€249.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
ANVISA · RDC 751/2022 · RDC 848/2024 · IMDRF ToC
ANVISA Technical Dossier Pack — Class III and IV
The full dossier as eight structured Word and Excel templates, laid out on the table of contents a reviewer expects to read.
€PRICE
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8 files · 6 chapters · Word and Excel
Instant download · yours to keep
The content is usually there. The dossier is not
A manufacturer with a CE-marked Class III device has the design history, the risk file, the validation reports and the clinical evidence. What it does not have is a Brazilian dossier, and the gap between those two things is structure: which chapter holds what, in what order, with which cross-references.
So the work starts on a blank page. Chapters get invented as they go, evidence is described in one place and assumed in another, and the Registration Holder receives a set of files nobody can review as a single document.
What is missing is not information. It is a skeleton with the sections already in the right order and a note in each one saying what belongs there.
- 8 files
- 6 dossier chapters
- Word and Excel
- IMDRF table of contents
- Class III and IV
- Instant download
Scope
What the pack covers
It covers the full technical dossier ANVISA requires for Class III and IV devices, built on the IMDRF table of contents. Every item is traced to the regulation, annex or guidance it comes from, rather than to a second-hand summary of it.
01
The structure
Six chapter templates on the internationally recognised table of contents ANVISA aligns with, so the dossier reads in the order a reviewer works through it instead of the order it was written in.
02
The guidance
Each chapter carries guidance notes, bracketed prompts and evidence tables. You replace the prompts with your device and delete them before submission; nothing is left as a blank heading.
03
The control
Headers, footers, document codes and an Excel master index tracking every document, its status and its revision — so a dossier spread across eight files stays coherent and auditable.
Contents
Eight files
Audience
Who the pack is for
- Manufacturers of Class III and IV devices preparing a full ANVISA registration
- Regulatory affairs consultants who want a submission-ready dossier skeleton
- Brazil Registration Holders assembling a dossier on a manufacturer’s behalf
- Teams standardising how their technical files are structured across markets
It assumes the underlying evidence exists, or is being produced. It is a structure for a dossier, not a substitute for the studies and records that go inside it.
What is included
What you get when you buy
- Eight files: a README, six chapter templates and a master index
- Fully editable Word (.docx) templates, nothing locked or protected
- An Excel (.xlsx) master index for document status and revision control
- Guidance notes, bracketed prompts and evidence tables throughout
- Consistent headers, footers and document codes across the set
- Instant download after purchase, licensed for single-organisation use
Questions
Before you buy
Are these editable Word files?
Yes. They are fully editable .docx templates that you complete for your device, plus an Excel master index. Nothing is locked, and you can add or restructure sections if your dossier needs it.
Why the IMDRF table of contents?
It is the internationally recognised dossier structure ANVISA aligns with. Building on it means the file reads the way a reviewer expects, and the same content can be reorganised for other markets that use the same table of contents.
Does it include the essential requirements checklist?
It includes an essential requirements chapter, with the structure and evidence tables to record conformity. The full RDC 848/2024 checklist with GSPR mapping is a separate product, also available inside the Gold Kit.
Does it cover Class I and II devices?
The pack is built for the full dossier required at Class III and IV. Lower-class registrations follow a lighter path and do not need this level of documentation.
Do I still need a Brazil Registration Holder?
Yes. A foreign manufacturer registers through a Brazil Registration Holder, which submits the dossier and holds the registration. The pack prepares what they submit.
Is it in Portuguese?
The templates are in English. Translation requirements depend on what the Registration Holder files and should be agreed with them before you start completing the chapters.
Can I use it on more than one device?
Yes. The licence is for single-organisation use, with no limit on how many dossiers you build from it. Keep one completed set per registration.
What if the regulations change?
The current version is 1.0, dated 2026, built on RDC 751/2022 and RDC 848/2024. Revisions issued after your purchase are available to you at no further cost.
Is this regulatory advice?
No. These are documentation templates. They do not replace a Brazil Registration Holder or case-specific verification, and a regulatory review of the completed dossier before submission is worth doing.
Can my company buy several copies?
The licence already covers your organisation. If you need a purchase order or an invoice with specific details, get in touch and we will arrange it.
Pack and checklist
The pack gives you the dossier. The checklist tells you whether it holds up.
Chapter 03 is where conformity with the essential requirements is claimed, and it is the chapter a reviewer tests hardest. The Essential Requirements Checklist scores those requirements one by one against RDC 848/2024, with the mapping to the EU GSPR so evidence written for a CE file can be reused. Both are included in the Gold Kit.
ANVISA Technical Dossier Pack
Eight files, six chapters on the IMDRF table of contents,
a master index in Excel. Instant download, yours to keep.
€249.00
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