WHAT WE DO
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.
ANVISA Medical Device Registration in Brazil
DOMO Salute has the knowledge and expertise to work out the correct classification for your
device and to assist with every step of the preparation and submission of your application.
Brazilian Registration Holder
The BRH is responsible for your device registration in Brazil and acts as a link between your
company and ANVISA.
Brazilian Good Manufacturing Practices Certification
GMP certification is required for class III and IV medical devices manufacturers in compliance
with the Brazilian requirements.
INMETRO and ANATEL Certification
Certifications in other Regulatory Agencies may be needed in order to meet the Brazilian
regulation and get ANVISA’s approval.