MORE THAN COMPLIANCE
Regulatory strategy for medical devices cosmetics in vitro diagnostics
Decisions that strengthen your product and open markets in Brazil, the US, Europe, the UK and Canada.
Trusted by manufacturers in Brazil and abroad
Find your regulatory path
Start with your product. We’ll help define the right market and regulatory pathway.
Medical Devices
Regulatory strategy for medical devices, implants and software, from development to global market access.
Cosmetics
Safety assessment, labeling review and market compliance for cosmetic products in Brazil, the EU and the US.
In Vitro Diagnostics
Classification, performance evaluation, registration and post-market for reagents, analyzers and tests.
WORKING WITH SOBEL
Where is your product today?
Every client arrives at a different moment. We shape the work around yours, in every market you sell: ANVISA, FDA, EU MDR/IVDR, UK MHRA and Health Canada.
01 · Project
Launching or entering a new market
A new product or a new country. You need the right route defined early and a team that takes it all the way to approval. How we work: Regulatory Projects, with fixed scope, price and timeline.
What we do
- Regulatory strategy and classification
- Gap analysis and technical file
- Submission: CE, FDA, ANVISA or Health Canada
02 · Partnership
Already on the market
Your registrations need care in every market you sell. You need a team that already knows your products. How we work: Ongoing Support, monthly, with regulatory and scientific lines and one contact.
What we do
- Renewals and changes
- Local representation and vigilance
- QMS upkeep and regulatory monitoring
03 · Priority
Facing a deadline
An authority or an auditor is waiting for your answer. You need a clear response strategy, now. How we work: Priority Project, from response strategy to technical answer.
What we do
- ANVISA requirements
- FDA additional information requests
- Notified Body and audit findings, CAPA
04 · On demand
Regulatory team or consultancy
Your team needs extra regulatory capacity, a market it does not cover yet, or specialist evidence. How we work: On-demand Support, regulatory and scientific capacity when you need it.
What we do
- Dossier review and regulatory capacity
- Submissions and representation in new markets
- Biological and clinical evaluation
WHY SOBEL
Regulation as a business decision, not a checklist.
Classification decides cost and timeline. The right class from day one avoids rework.
Market sequence decides cash flow. Which country comes first changes how fast revenue starts.
One strategy, many markets. Evidence built once, reused across regulators.
“We know how regulators think, because we’ve been one of them.”
Maik EndlerFounder & CEOFormer BSI auditor (Notified Body)
One multidisciplinary team. Regulatory affairs, biological and clinical safety, toxicology and quality specialists working together on your project.
Meet the team →CLIENT VOICES
Trusted for decisions that move products forward.
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Fast solutions, focused on your goals
“Sobel provided a friendly, goal-oriented service with fast solutions. We look forward to working together on future projects.”
Andreas Kohl
CEO · Andratec
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Broad expertise, real collaboration
“I experienced always supportive, pro-active collaboration from Sobel Consult with high degree of competency in broad regulatory range.”
Mandy Blocher
Expert Regulatory Framework & Digital Transformation · Aesculap AG (B. Braun)
Clear regulatory direction
The right pathway and priorities for your product.
Fast and responsive support
We act quickly to keep projects moving.
Practical guidance
Actionable advice for your next step.
Latest insights
Insights and updates to help you navigate compliance with confidence.
News: ISO 10993-1:2025 Is Now ABNT NBR – What It Means for ANVISA
ISO 10993-1:2025 is now ABNT NBR in Brazil. See what changes in biological evaluation for ANVISA registration.
EUDAMED Deadline 2026: What to Do Before 27 November
Your devices have been on the EU market for years. They have valid certificates, a technical file and a vigilance process. But if they are not yet registered, the EUDAMED
FDA and Generative AI-Enabled Medical Devices: What the 2026 Discussion Paper Signals for Manufacturers
Generative AI medical devices are moving into a new regulatory phase. In its 2026 discussion paper, the FDA examines how risk, evidence, postmarket monitoring and third-party model dependencies may need
FAQ
Questions we hear before every first call
Clear answers to what manufacturers ask us most, across Brazil, the US, Europe and Canada.
Ask your question →Do we need a local representative in each market?
In Brazil, the US, the EU and the UK, yes: foreign manufacturers need a local representative, such as a Brazilian Registration Holder for ANVISA, a US Agent for the FDA or an EU Authorized Representative. We act as, or coordinate, your representation, so you can sell without opening a company in each country.
Should our distributor hold our registration?
You can, but the registration then depends on that partner. With an independent representative, the registration follows your strategy, so you can change or add distributors without starting over.
Can we reuse our CE marking or FDA clearance in other markets?
Often, yes. Many regulators follow IMDRF principles and accept MDSAP audit reports, so evidence built for one market can support the next. We map what transfers, what is missing and which market should come first.
We are a Brazilian manufacturer. Can you take our product to Europe or the US?
Yes. We support Brazilian manufacturers entering the EU, the UK, the US and Canada, from regulatory strategy and technical documentation to representation, with experience gained inside a European Notified Body.
How long does it take, and what does it cost?
It depends on the product class, the market, the route and the evidence you already have. Authority fees also vary by market and company size. After a short assessment, you receive a scope with a fixed price and timeline.
We received an ANVISA requirement, an FDA request or an audit finding. Can you help?
Yes. Send us the document and its deadline. We review it, define the response strategy and prepare the technical answer with your team.
Do we need a long-term contract?
No. Many clients start with a single project and move to monthly ongoing support once their product is on the market.
