This is a simplyfied overview! Together with our local strategic partners, we specialize in assisting manfacturer's to determine their strategy for meeting these requirements and then implementing it. Contact Us
For most companies the access point to South America is Brazil. Brazil is the second largest healthcare market in the Americas (bigger than Canada and second only to the U.S.A.) and a member of the South American Free Trade Area, Mercosur. A common strategy for entering South America is:
Mercosur has a "common-ish" approach to Medical Device Regulation, but seperate submissions have to be in each country, and of course different state-regulators can interpret the same rules in different ways!
Unlike the other Mercosur countries, and the rest of South America, Portuguese is the language of Brazil - in fact more correctly Brasilian-Portuguese, rather different to European-Portuguese. Brazil also hosts the biggest Medical Trade Fair in South America every June Hospitalar.
Products can only be registered in Brazil by a company established in Brazil. For a company looking to export to Brazil, there are three common mechanisms:
To start a local company and then obtain the necessary registration from ANVISA as a medical device establishment typically takes 12 - 18 months. Using a distributor, who is already established as a company and holds an ANVISA registration can eliminate this, however the distributor will then hold the registration of your product and will be able to decide whether to allow the appointment of secondary distributors. We have seen cases of distributors turning an agreement into an exclusive agreement and even changing manufacturers. The third option of using a third party (like an EU Authorized Representative in Europe) to hold the regulatory responsibility as the initial importer, but to allow importation to any number of distributors offers the same advantages as using a distributor directly, but without the disadvantages.
Products can be registered individually or as "families"; each family member must have:
So for example a range of catheters of different sizes can be a family, but the same size catheters for a different intended use or made of a different material can not.
There are really three parts to registering a product in Brazil:
The official documents (for example: a certificate of free trade, authority to distribute) may need to be notarized (by a Notary Public), have a "sworn" translation and be certified by the nearest Brazilian Consulate in your home country.
The product details (for example: Brazilian Labeling, Directions for Use, Service or Operator Manual) are basically the same as those required by a US 510(k) or EU CE Marking Technical File.
The formal report is again very analgous to an EU CE Marking Technical File, explaining the product, how it works, what it is intended to do and summarizing the testing and clinical experience to demonstrate it is both safe and effective.
Some tests may need to be repeated in Brazil to the appropriate Brazilian Version of a standard.
Like most international agencies, ANVISA makes charges for reviewing submissions. These are generally called taxes and are calculated by a formula based on the submission and the size of the company making the submission.
Product registration is valid for 5 years, but the re-newal process should be started at least 6 months before the original registration runs-out.
Brazil has its own Good Manufacturing Practice Regulations. ANVISA is currently investigating the use of third-parties to conduct international inspections and has announced an intention to inspect internationally. However this is achieved, the possibility of getting an "FDA-style" inspection from Brazil is fast becoming real rather than just theoretical!
The other Mercosur countries operate similar systems.
MeddiQuest use local partners in South America to make submissions to the various regulatory agencies. We believe it is important to have a local contact who can keep abreast of changing regulations and is ready to discuss submissions on a face-to-face basis with regulators. We believe it is equally important that we prepare documentation before contacting local partners to ensure that money and time is not wasted when incomplete information is available and that documents are not translated needlessly.
There are many other issues to consider before entering the South American market: Intellectual Property, Trade Mark, Contracts etc. Through our membership of "Global Business Development Group" and "Global Overseas" MeddiQuest offers a "one-stop shop" for access to all the local lawyers, accountants, marketeers and other specialists that you may need.
For more information on South America, please contact us: