Sale!
Full Brazil Market Access Kit

Full Brazil Market Access Kit

Original price was: €487.00.Current price is: €399.00.

SKU MDR-BR-GOLD Category Tags , , , , , ,

ISO 13485 & MDSAP Ready

Editable Word & Excel

ISO 13485 / MDSAP / FDA QMSR

Used by 100+ quality teams

The complete Brazil toolkit: score your file, map the essential requirements, and build the technical dossier — the three kits that together take you from where you are to a filing-ready ANVISA submission.

Bought together as the Gold Kit, the three save you compared with buying them separately.

What’s inside

All three Brazil kits, in one download:

  • ANVISA Gap Analysis — 18-sheet scored workbook, 359 items, with the DO-NOT-FILE gate.
  • Essential Requirements Checklist — 119 RDC 848/2024 requirements, GSPR cross-referenced.
  • Technical Dossier Pack — eight fill-in Word templates on the IMDRF ToC, plus master index.

Why it works

  • The full method, end to end. Assess with the gap analysis, evidence with the checklist, assemble with the dossier pack — one coherent workflow.
  • 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.
  • 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.
  • Straight from the regulations. Every item is traced to the regulation, annex or guidance it comes from — not a second-hand summary.

How to use it

  1. Start with the gap analysis to see where your file stands.
  2. Use the checklist to evidence the essential requirements, reusing CE evidence via the GSPR mapping.
  3. Build the dossier from the technical templates.
  4. Resolve every killer item, then hand a filing-ready file to your BRH.

Who it’s for

  • Manufacturers preparing a complete ANVISA registration
  • RA consultants who want the full Brazil toolkit in one purchase
  • Teams that will reuse the method across multiple devices

What the bundle includes

  • ANVISA Gap Analysis — Brazil — normally €149
  • Brazil Essential Requirements Checklist — normally €89
  • Brazil Technical Dossier Pack — normally €249

Bought separately these come to €487. As the Gold Kit they are €399 — a saving of €88.

Specifications

Format Excel (.xlsx) + Word (.docx)
Included kits Gap analysis, essential requirements checklist, technical dossier pack
Files 10 in total
Regulatory basis RDC 751/2022; RDC 848/2024; IMDRF ToC
Language English
Delivery Instant download after purchase
Licence Single-organisation use; yours to keep
Version 1.0 · 2026
Good to know. These are documentation tools, not regulatory advice, and do not replace a Brazil Registration Holder or case-specific verification.

Frequently asked questions

What do I save versus buying separately?

The three kits are €487 bought individually; the Gold Kit is €399, a saving of €88.

Is it the same files, just bundled?

Yes — you receive the full, unmodified contents of all three kits in one download.

Do I still need a BRH?

Yes. The bundle prepares and de-risks the file; a Brazil Registration Holder still submits it.

Original price was: €487.00.Current price is: €399.00.

Related products

Picture of Alessandro Stella

Alessandro Stella

Alessandro Stella is a freelance Medical Device Regulatory Consultant and ISO 13485 / ISO 9001 Lead Auditor based in Italy. With over 13 years of experience spanning R&D, Quality, and Regulatory Affairs, he has supported companies across Europe and beyond in EU MDR technical documentation, QMS implementation, ISO 13485 compliance, and FDA submissions. His device expertise covers cardiovascular devices, AI-based standalone software, robotic surgery systems, active wearables, and more. Alessandro is the founder of MD Regulatory.