ANVISA Gap Analysis — Brazil

Registering a medical device with ANVISA means proving conformity across hundreds of discrete requirements drawn from RDC 751/2022 and the essential requirements of RDC 848/2024. Miss one mandatory item and the submission can stall for months.

This workbook turns that sprawl into a single, scored checklist. You mark each requirement Yes / No / Partial / N/A, record your evidence, and a live dashboard tells you how complete the file is — and whether any killer item still blocks filing.

What’s inside

18 worksheets, 359 evaluable requirements, one Excel file:

• Instructions — how to use the workbook, the scoring scale and the filing gate.
• Class & Route — Class I–IV, Notification vs Registration, and the evidence each demands.
• Dashboard — live counts and the DO-NOT-FILE gate driven by your answers.
• 00 Killer items — the mandatory items that block filing if unresolved.
• Requirement sheets — prerequisites, technical documentation, essential requirements, risk management, clinical, labelling, BGMP, post-market, UDI and more.
• Client questions & References — what to ask the client, and the regulatory register behind every item.

Why it works

• A filing gate, not just a list. The dashboard returns DO NOT FILE while any killer item is unresolved, so you never submit an incomplete file by accident.
• 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.

How to use it

1. Confirm the device class and route on the Class & Route sheet.
2. Score each requirement Yes / No / Partial / N/A and record your evidence.
3. Watch the dashboard flag gaps and killer items in real time.
4. Resolve every blocker, then hand a clean, filing-ready file to your local representative.

Who it’s for

• Manufacturers preparing a first ANVISA submission
• RA consultants who want a rigorous, ready-made scaffold
• Distributors and Brazil Registration Holders assembling a file on a manufacturer’s behalf
• QA/RA teams pressure-testing a file before it goes in

Specifications

Frequently asked questions