Brazil Essential Requirements Checklist
€89.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
RDC 848/2024 · ANVISA · EU MDR GSPR
ANVISA Essential Requirements Checklist (RDC 848/2024)
All 119 essential requirements of RDC 848/2024, each one mapped to the matching EU MDR GSPR, so you locate evidence you already hold instead of starting from a blank page.
€89
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Excel workbook · 119 requirements · GSPR cross-reference
Instant download
The essential requirements get rebuilt from nothing, twice
A manufacturer already holding a CE technical file starts the ANVISA submission the same way it started the European one: requirement by requirement, evidence gathered again from the design file, the risk file, the validation reports. Most of that evidence already exists. It was produced once, against the EU MDR General Safety and Performance Requirements, and RDC 848/2024 asks for the same things under a different numbering.
The second failure is quieter. The requirements get ticked as met without a recorded method or a reference to the evidence, so the file shows a conclusion with nothing behind it — the first thing a reviewer asks for.
Neither is a hard problem. Both come from treating RDC 848/2024 as a new list rather than as a set of requirements that mostly already have an answer sitting in the CE file.
- Excel workbook
- 119 essential requirements
- EU MDR GSPR cross-reference
- English
- Instant download
- Single-organisation licence
Scope
What the kit covers
Every essential requirement in RDC 848/2024, organised by theme and traced back to the regulation itself — not a second-hand summary of it.
01
The 119 requirements
Each requirement stated in full, grouped by theme, in the order a reviewer works through the technical file.
02
The GSPR cross-reference
Every requirement pointed to its matching EU MDR General Safety and Performance Requirement, so a CE file becomes a source of evidence rather than a separate exercise.
03
Applicability, method and evidence
Three columns per requirement that turn the checklist into a controlled document: whether it applies, how conformity is demonstrated, and where the evidence sits.
Contents
What the workbook contains
Audience
Who the kit is for
- Manufacturers mapping an existing CE technical file onto ANVISA requirements
- RA consultants assembling the essential-requirements evidence
- Quality managers building or reviewing an ANVISA technical file
- Anyone who needs RDC 848/2024 in a workable, trackable form
The kit assumes you know your device’s classification and already have, or are building, a technical file. It is a documentation tool, not regulatory advice: the GSPR cross-reference helps you locate evidence, it does not establish legal equivalence between the two regimes.
What is included
What you get when you buy
- One Excel workbook (.xlsx), 119 essential requirements
- EU MDR GSPR cross-reference against every requirement
- Applicability, method and evidence columns, colour-coded, with dropdowns
- Guidance on completing and maintaining the checklist as a controlled document
- Single-organisation licence — yours to keep
- Instant download after purchase
Questions
Before you buy
How is this different from the gap analysis?
The gap analysis scores a whole ANVISA submission across 359 items, with a filing gate. This checklist focuses specifically on the RDC 848/2024 essential requirements and their GSPR mapping.
Can it sit in my technical file as-is?
Yes. It is structured to be completed and kept as the essential-requirements evidence within your ANVISA technical file.
Is the GSPR mapping a legal equivalence?
No. It is an aid to locate matching evidence in a CE file. Conformity still has to be demonstrated against the Brazilian requirement itself.
Do I need a copy of RDC 848/2024 to use this?
No. Every requirement is quoted in full inside the workbook. You will still want the regulation itself for anything the checklist references but does not reproduce, such as annexes and definitions.
What format does it come in?
A single Microsoft Excel (.xlsx) file, available for instant download after purchase.
Is this a one-off purchase?
Yes. The licence is for single-organisation use and the file is yours to keep, with no recurring cost.
Does the workbook get updated if the regulation changes?
The current version is 1.0, dated 2026, against the regulation as in force. Check the product page for later versions if RDC 848/2024 is amended.
Can I buy this for multiple projects?
The licence covers your organisation, so you can reuse it across your own device families. Contact us first if you need to license it beyond a single organisation.
Checklist and gap analysis
This checklist maps the requirements. The gap analysis scores the whole submission.
The essential requirements are one part of an ANVISA technical file. Once they are mapped and evidenced, the gap analysis checks the full 359-item submission against a filing gate, so the two are normally worked in sequence, not as alternatives.
ANVISA Essential Requirements Checklist (RDC 848/2024)
119 essential requirements, mapped to the matching EU MDR GSPR, in one Excel workbook you keep.
€89.00
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