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Medical devices and IVD · Brazil

A Brazilian Registration Holder independent from your distributors

To sell a medical device or IVD in Brazil, a Brazilian company authorised by ANVISA holds the notification or registration. Sobel offers this service through a qualified partner, so your products are not tied to a distributor.

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Is this for you?

Who we do this for

First time in BrazilYou have no Brazilian company and need a holder to file with ANVISA.

Registered with a distributorYour registration sits with a distributor and you want more independence.

More than one distributorYou want to work with several importers in Brazil.

Changing holderYou want to change who holds your products and need to know what is possible in your case.

What you get

What the holder service includes

One team coordinates the regulatory work; our qualified partner acts as the holder of your products in Brazil.

A holder with the ANVISA company authorisation and a technical lead, through our qualified partner
Preparation of the notification or registration and follow-up with ANVISA
Support for vigilance and field actions, based on the information you provide
Changes, UDI data and renewals planned on a shared calendar
Technical documentation organised for ANVISA requests
Support for the importers you choose to work with

Who does what

Clear roles from the start. The details are set in the contract for each case.

Topic	You, the manufacturer	The holder (our partner)	Sobel
Product and quality system	Owns the design, the technical file and the quality system	Keeps the documentation ANVISA may request	Adapts the file to the ANVISA format
Manufacturer declaration	Issues the declaration naming the holder	Is named in it as holder	Prepares the text with you
ANVISA filing	Provides documents and answers	Files as the holder	Prepares the petition and follows up
Vigilance and field actions	Investigates and proposes actions	Communicates with ANVISA in Brazil	Coordinates both sides
Import and sale	Chooses the distributors	Supports the importers you choose	Keeps the paperwork current

How it works

1ReviewWe look at your products, their classes and their current situation in Brazil, including any registration held by a distributor.
2DeclarationYou sign the manufacturer declaration that names the holder. We tell you the format and legalisation it needs.
3FilingThe holder files the notification or registration. If you are changing holder, we first check which route applies to your case.
4After approvalVigilance, changes, UDI data and renewals, planned on a shared calendar.

Talk to a specialist

Keep exploring

Medical Devices · BrazilClasses, routes and the full ANVISA pathway.→IVD · BrazilHow ANVISA classifies and regulates IVDs.→Product stuck at ANVISA?Rejected or stalled filings, analysed and answered.→

Why Sobel

Regulation as a business decision, not a checklist.

Four disciplines work on every project, in the same team, from the first decision to post-market.

Strategy

Classification and market sequence decided first. The right class from day one avoids rework.

Science in house

Biological, clinical and toxicological evaluation by our own Clinical Evidence & Product Safety team.

Regulatory, five markets

ANVISA, FDA, EU MDR, MHRA and Health Canada, coordinated together.

Technology

A dedicated technology team builds the workflows that keep every project traceable and on time.

“We know how auditors think, because we’ve been one of them.”

Maik Endler

Founder & CEO

Mechanical engineer, trained in Germany
Former BSI auditor (Notified Body)
Industry experience at Sirona (now Dentsply Sirona)

Questions, answered

Frequently asked questions

Rules cited on this page: RDC 751/2022 · RDC 830/2023 · RDC 16/2014 · RDC 67/2009 · RDC 551/2021 · RDC 903/2024 · RDC 591/2021 · RDC 81/2008

Why does a foreign manufacturer need a Brazilian holder?

ANVISA grants notifications and registrations to a Brazilian company responsible for the product in Brazil. That company needs an ANVISA company authorisation, a local health licence and a technical lead. A foreign manufacturer without a Brazilian subsidiary usually works with a holder.

Is Sobel the holder?

No. Sobel offers the holder service through a qualified partner. Sobel coordinates the regulatory work, and the partner holds the notification or registration for you.

Can my registration be moved away from my distributor?

Sometimes. The options depend on the type of product, whether it is notified or registered, and the cooperation of the current holder. In some cases a transfer is possible; in others the new holder files again. We review your case and explain the options before any step.

Can I sell through more than one distributor?

In many cases, yes. Importers with their own ANVISA authorisation can work with products held by another company, following ANVISA import rules. We check how this applies to your products.

What does the holder do after approval?

The holder keeps the product compliant in Brazil: it communicates with ANVISA on vigilance and field actions, files changes, keeps the documentation available and manages renewals when they apply. We plan these steps with you.

What do you need from us?

A declaration from the legal manufacturer that names the holder, your technical documentation and, depending on the class, evidence about your manufacturing quality system. We send you a checklist for your products after the first review.