WELCOME TO QUALITHINGS
Integrated Solutions for Medical Device Companies
│Quality Assurance and Regulatory Affairs │
We Can Act as a Link Between Your Company and Anvisa
The Brazilian legislation establishes that only national companies can register medical devices, and these companies must have local and federal sanitary licenses. Foreign companies that wish to register their products in Brazil must have a partner company legally constituted in Brazil, such as QualiThings, that will be the holder of the authorization issued by Anvisa and legally responsible for the products imported to and distributed in the Brazilian territory.
We Can Act as a Link Between Your Company and Your Clients
Appointing an Anvisa representative gives you more flexibility and control over your products than appointing a distributor for that role. This means there’s no need to choose a distributor beforehand: you can start your registration process while learning about the Brazilian market and getting to know the distributors. Brazilian legislation allows the registration holder to give import permits authorizing the distributor(s) of your choice to import your devices.
How We Can Help
Entering a new market brings multiple challenges, especially for manufacturers of highly regulated products such as medical devices. But with careful planning and appropriate assistance, exporters of all sizes can have fruitful business opportunities and be successful in the Brazilian market. In fact, the potential rewards outweigh any challenges.
Product Registration
& Market Authorization
Our experts can prepare the product’s technical dossier, which shall include a complete technical file containing clinical data, biocompatibility studies, performance tests, instructions for use, and other documents required by Anvisa.
Product Distribution
& Billing Management
QualiThings can assist foreign manufacturers by creating distribution strategies in the Brazilian market through distributors or distribution centers specialized in health products.
Good Manufacturing Practices (GMP)
The Brazilian Good Manufacturing Practices (BGMP) are mandatory procedures created by Anvisa to ensure minimum quality standards in the manufacturing of health products, and apply to all companies that manufacture medical devices.
Tax Planning
& Accounts Receivable
Our professionals are trained to analyze, plan, and develop strategies considering what is beneficial for its partners and in compliance with the Brazilian legislations.
Post-Market Surveillance
& Strategies
Our post-registration services involve evaluating your requirements and suggesting inputs to the business processes that are designed to ensure customer satisfaction as well as compliance.
Registration Maintenance
& Hosting
We keep updated with the latest news and regulatory changes. We can timely alert the companies in case any action is required to maintain the product registration valid and avoid penalties.
Contact Us
BRAZIL - RS - PORTO ALEGRE
Rua Luiz Voelcker, 835, sala 5,
Porto Alegre, RS 91330-190
+55 (51) 3937-8827
EUA - FL - MIAMI
1150 NW 72nd Ave #455, Miami, FL 33126, EUA
+1 (689) 233-9730