Our Services
The first step is to determine the medical device classification. In Brazil, devices are divided into four classes, based on their risk (Classes I to IV, from very low to very high risk) and market authorizations are issued by Anvisa depending on the risk class. QualiThings will carry out the analysis to ensure the correct classification of products based on Brazilian standards. Afterwards, our team will be dedicated to adjusting the product’s documentation, as required by Anvisa. prepare the product’s technical dossier, which shall include a complete technical file containing clinical data, biocompatibility studies, performance tests, etc.
BGMP is a set of mandatory procedures created by Anvisa to ensure minimum quality standards in the manufacturing, storage, transportation, and distribution of health products. The main objective is to ensure that all products are safe, effective, and of high quality.
BGMP applies to all companies that manufacture medical devices, located either on national territory or abroad. Manufacturers of Class III and IV medical devices must be certified in compliance with the BGMP requirements before they can register their products in Brazil.
QualiThings can help manufacturers adhere to these practices through its consulting services.
After the medical device is approved for commercialization by Anvisa, selling the product might pose another challenge. In Brazil, the healthcare market is price-driven. The Government of Brazil, which is the sponsor of several hospitals, is the main buyer of healthcare products to supply the Brazilian public healthcare system (SUS), the largest of its kind in the world. Foreign companies can participate in these bids, as long as they have a Local Representative.
QualiThings has an active database containing the main medical device stakeholders in Brazil, including over 6,000 public and private hospitals. Our sales services are connected to the public and private procurement systems in Brazil, allowing foreign companies to access bids throughout the Brazilian territory, including in large hospitals with high demand for health products.
Whether you are a small or a large-scale manufacturer, your business expansion, continual improvements, and customer satisfaction rests mainly on the quality standards of your business.
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.
QualiThings can assist foreign manufacturers by creating distribution strategies in the Brazilian market through distributors or distribution centers specialized in health products. The company has numerous partners throughout Brazil, which allows us to ensure that products are delivered to their locations in adequate condition in a timely manner. We have the ability to reduce delivery times while benefiting customers.
Operating in Brazil offers an additional challenge related to tax planning for foreigner companies. The laws and regulations are complex and difficult to understand. QualiThings have professionals trained to analyze, plan, and develop strategies considering what is beneficial for its partners and in compliance with the Brazilian legislations.
Moreover, we can manage the manufacturers’ accounts receivable by creating specific procedures according to the size and needs of each client. Our company will exchange files with banks, and register, reconcile, and write off paid bills, as well as solve operational and logistical problems that may affect foreign partner in Brazil.
Product Registration Certificates are valid for 10 years and the renewal application must be submitted in a timely manner. Any post-approval changes made to the medical devices must be sent to Anvisa, with relevant documents according to the current requirements.
As part of our daily routine, QualiThings follow all official publications, keeping updated with the latest news and regulatory changes. We can timely alert the foreign companys in case any prompt action is required to maintain the product registration valid and avoid penalties.
Get in touch
Send us a message, we will be glad to help you through the pathway into the Brazilian market.
+55 (51) 3937-8726