Meet Sobel at MEDICA 2026·Düsseldorf, 16–19 Nov.Book a meeting with us →Book a meeting Who we serve · Medical devices
Brazil, the EU, the UK, the US and Canada each classify, review and inspect in their own way. We plan the order, the route and the files, so the work you do for one market counts in the next.
Where do you want to sell?
Not sure where to start? Map your route in Sobel Route →In short
How market access for medical devices works
Every market sets its own risk classes, route to approval and local representative. What travels well between them is the core: an ISO 13485 quality system, the ISO 14971 risk file, biological and clinical evidence. Sobel builds that core once, then adapts it to ANVISA, the EU MDR, the UK MHRA, the FDA and Health Canada, in the order that makes sense for your device and your business.
Last updated 31 Oct 2026 · Reviewed by Sobel’s regulatory team
Trusted by medical device manufacturers in Brazil and abroad
Your markets
Pick a market to see its classes, route, local presence and quality system, and how Sobel helps there.
Brazil · ANVISA
How Sobel helps
Classification, dossier, GMP certification and the holder, with ANVISA requirements answered by the same team.
Ongoing support: keep Sobel as your regulatory team in Brazil, with a monthly scope built around your portfolio: changes, renewals, ANVISA requirements and post-market. How it works →
Europe · EU MDR
How Sobel helps
Technical documentation, clinical evaluation, the Notified Body process and your Authorized Representative, from one team.
Ongoing support: keep Sobel as your regulatory team for Europe, with a monthly scope built around your portfolio: technical documentation updates, Notified Body questions and post-market surveillance. How it works →
United Kingdom · MHRA
How Sobel helps
Your route into Great Britain (CE or UKCA), MHRA registration and the UK Responsible Person through our qualified partner.
Ongoing support: keep Sobel as your regulatory team for the UK, with a monthly scope built around your portfolio: MHRA registrations, changes and post-market surveillance. How it works →
United States · FDA
How Sobel helps
Pathway strategy, the 510(k) or De Novo file, registration and listing, and your US Agent, from one team.
Ongoing support: keep Sobel as your regulatory team for the US, with a monthly scope built around your portfolio: annual registration and listing, changes and FDA questions. How it works →
Canada · Health Canada
How Sobel helps
Classification, the licence application and MDSAP preparation, aligned with your other markets.
Ongoing support: keep Sobel as your regulatory team for Canada, with a monthly scope built around your portfolio: licence amendments, MDSAP follow-up and Health Canada questions. How it works →
Sources: ANVISA RDC 751/2022 and RDC 665/2022; Regulation (EU) 2017/745; FDA 21 CFR Parts 807, 814, 820 and 860; UK Medical Devices Regulations 2002 and MHRA guidance (updated 20 Feb 2026); Health Canada Medical Devices Regulations (SOR/98-282). General overview, not legal advice: your device’s class and route are confirmed in your plan.
The numbers behind your timeline
Demand keeps growing: 13,953 certificates in 2025, against 25,978 applications, across 52 Notified Bodies.
Team-NB, Medical Device Survey 2025 (41 of 52 designated Notified Bodies), new MDR certificates.
Class I and II Notification
Class III and IV Registration
77 applications from 55 companies rejected in a single resolution. Each one goes back to a review queue that can already take 9 to 12 months.
Reasons presented by ANVISA’s technical areas (GEMAT, GGTPS) at the ABIMO panel, Hospitalar 2026; Resolution RE 2,804 of 16 Jul 2026; queue: ANVISA GGTPS figures for 2024, ABIMED.
Most devices reach the US through an existing pathway. Choosing the right one is the first decision.
FDA, CDRH 2025 Annual Report.
We can’t shorten a regulator’s queue. We can make sure you join it with a complete file, in the right market order.
Book my assessmentRules change, and nobody tells you in person. RDC 751/2022 replaced RDC 185/2001, RDC 665/2022 rewrote Brazilian GMP and ISO 10993-1:2025 is now an ABNT NBR standard. With ongoing support, Sobel follows the ANVISA changes that affect your portfolio and tells you what to do, before an inspection or a renewal does.
How ongoing support works →Already in one market?
Most of your file can travel. We check what you already have, show what can be reused, what needs adapting and what is new, before you spend on the next market.
Example: CE marked in Europe, now Brazil
Your technical documentation, risk file and biological evaluation are the base. ANVISA adds its own classification, the Brazilian GMP for classes III and IV, a Brazilian Registration Holder and labels in Portuguese.
What we do for medical devices
Regulatory strategy and the safety evidence behind it, planned together so reviewers see one consistent story. Choose a team to see how it works.
Regulatory & Quality
Clinical Evidence & Product Safety
Where are you today?
A rejection, a technical requirement or a file that stopped moving. We read the letter and plan the answer.
What to do now →
A Brazilian Registration Holder independent from your distributor, through our qualified partner.
See the holder service →
The key changes in the new biological evaluation standard and a step-by-step plan.
Download the guide →Why Sobel
Andreas Kohl
CEO · Andratec
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.”
Mandy Blocher
Expert Regulatory Framework & Digital Transformation · Aesculap AG (B. Braun)
Broad expertise, real collaboration
“I experienced always supportive, pro-active collaboration from Sobel Consult with high degree of competency in broad regulatory range.”
It depends on your device class, where your evidence already stands and where your buyers are. We compare effort, timeline and cost for each market and suggest an order in your plan.
Much of it, yes: the quality system, risk file, biological evaluation and test reports are the base. Each regulator adds its own classification, forms and local requirements, which we map before you start.
Brazil requires a Brazilian Registration Holder, the EU an Authorized Representative, the UK a UK Responsible Person and the US a US Agent, for manufacturers based outside each market. Sobel acts directly as your EU Authorized Representative and US Agent through its own companies there; the Brazilian holder and the UK Responsible Person are offered through qualified partners.
Health Canada requires an MDSAP certificate for classes II to IV. In Brazil and the US it is optional, but the audit report can be used by ANVISA and the FDA.
It depends on the class and the route in each market. Your plan shows the timeline for each step before you commit.
Yes, for Brazil. See our IVD page for ANVISA registration of reagents, analysers and tests.
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