Brazil Essential Requirements Checklist

Brazil’s essential requirements of safety and performance (RDC 848/2024) are the backbone of an ANVISA technical file. This checklist lays out all of them in a structured, fill-in workbook.

Crucially, every requirement is mapped to the matching EU MDR General Safety and Performance Requirement (GSPR) — so if you already hold a CE technical file, you can locate the evidence you need instead of starting from a blank page.

What’s inside

One Excel workbook covering the essential requirements:

• 119 essential requirements from RDC 848/2024, organised by theme.
• EU MDR GSPR cross-reference column against every requirement.
• Applicability, method and evidence columns to record how each requirement is met.
• Guidance on how to complete and maintain the checklist as a controlled document.

Why it works

• EU GSPR cross-referenced. Essential requirements point to the matching EU MDR GSPR, so you can locate and reuse evidence from an existing CE technical file.
• Straight from the regulations. Every item is traced to the regulation, annex or guidance it comes from — not a second-hand summary.
• Built to be completed. Colour-coded fill-in fields, dropdowns and a clean print layout — designed to be worked in, not just read.
• A controlled document, ready to file. Structured so it can sit directly in your ANVISA technical file as the essential-requirements evidence.

How to use it

1. Confirm which requirements apply to your device and justify any exclusions.
2. For each requirement, state the method of conformity and reference the evidence.
3. Use the GSPR column to pull matching evidence from an existing CE technical file.
4. Keep the completed checklist in your technical file as controlled evidence.

Who it’s for

• Manufacturers mapping a CE file onto ANVISA requirements
• RA consultants assembling the essential-requirements evidence
• Anyone who needs the RDC 848/2024 requirements in a workable, trackable form

Specifications

Frequently asked questions