Company’s Sanitary Legalization

Company sanitary legalization is mandatory for any company wishing to do business in Brazil in the medical field. The Brazilian legislation establishes that only national companies are able to register medical devices, and these companies must have local and federal sanitary licenses for the activities to be carried out (manufacture, import, etc.) It is worth mentioning that among the requirements for the company’s sanitary authorization are the implementation of a Quality Management System (QMS) and the Technical Responsibility assumed by a duly qualified professional, as well as documentation and infrastructure compatible with the proposed activities. Once legally authorized, the company is now able to be a Brazilian registration holder. DOMO Salute offers support to your company in obtaining all the mandatory sanitary licenses and certificates in order to meet the Brazilian regulation.