Registration and approval of your medical devices with ANMAT, ANVISA, FDA and CE
We design and manage your medical device registration in one or several jurisdictions at once, with a single base dossier that avoids redoing documentation country by country.
Who this service is for
- Manufacturers entering Argentina, Brazil, the United States or the European Union.
- Companies already selling in one country that need to expand to other markets.
- Medtech and biotech startups that need their first registration done right.
- Importers and distributors that need to manage registration holdership.
What we solve
Delays and rejections rarely come from the product: they come from the process. A rushed classification, a dossier inconsistent across countries or a poor answer to a query can cost months. Our job is to make sure that does not happen.
What it includes
- Product risk classification in each target jurisdiction.
- Definition of the regulatory route and the optimal submission sequence.
- Technical dossier preparation, with base documentation reusable across markets.
- Management and follow-up with ANMAT, ANVISA, FDA and the Notified Body (CE).
- Responses to authorities’ queries and information requests.
- Sequencing strategy (for example, ANMAT and then ANVISA) to accelerate the whole.
Jurisdictions we cover
- ANMAT — ArgentinaRegistration of medical devices and medical technology, all risk classes.
- ANVISA — BrazilRegistration and notification, sequenced appropriately with the rest of the portfolio.
- FDA — United States510(k), De Novo or PMA pathways depending on device classification.
- CE marking — European UnionUnder the Medical Device Regulation (MDR) framework.
Why coordinate it in a single strategy
When each country is handled separately, the same information is rewritten several times, contradictions appear between files, and you lose the chance for one approval to leverage the next. With a common base dossier and a planned sequence, the whole moves faster and with less risk of rejection.
Frequently asked questions
How long does it take to register a medical device with ANMAT?
It depends on the risk class and the quality of the submitted file. A well-built dossier, with the correct classification and prompt answers to queries, is what shortens the timeline most. In the first conversation we estimate a realistic schedule for your case.
Can I register in Argentina and Brazil at the same time?
Yes. In fact, deciding the submission order (ANMAT first, ANVISA first or in parallel) is a strategic variable we define based on your product and commercial goals.
Do I need ISO 13485 to register?
It depends on the jurisdiction and product class. In many cases the quality system is part of the requirements. If you do not have it yet, we work on it alongside the registration (see the ISO 13485 service).
Do you work with Class I, II, III and IV products?
Yes, with all risk classes. The regulatory route changes with the class, and defining it well from the start is precisely the part that most affects the final timeline.
You may also need
ISO 13485 Quality Management System
Implementation of your audit-ready QMS, aligned with the FDA QMSR now in force.
View service ComplyISO 14971 risk management
The risk management file your dossier requires in any jurisdiction.
View service ComplyRegulatory affairs and ongoing compliance
Renewals, change management and post-market surveillance to keep your product current.
View serviceWhich product do you want to register, and in which markets?
Tell us your case. The first conversation is for understanding the product and estimating a realistic path, free of charge.