Medical Device Product Registration and Approval
MEDICAL DEVICE REGULATION IN BRAZIL
Medical devices are regulated by the Brazilian Health Regulatory Agency (ANVISA) from the Ministry of Health in Brazil. Its primary objective is to protect and promote public health by exercising health surveillance over products and services and this includes any processes, ingredients, and/or technologies that may pose any health risk. Medical devices are regulated under Law No 6,360.
MEDICAL DEVICE REGISTRATION AND APPROVAL IN BRAZIL
Medical devices are classified into class I, II, III and IV (I being the lowest risk and IV being the highest risk).
There are 2 registration routes in Brazil; Cadastro registration route for the lower risk devices, and Registro registration route for the higher risk device. The significant difference between the 2 routes, is that the higher risk device requires a more detailed information from the technical file and it includes the Clinical Evaluation.
LATIN AMERICA REP
Foreign manufacturers must appoint an US agent as a local point of contact with US FDA.
If you are a foreign manufacturer, you may appoint ARQon to act as your authorized representative in the US.
Some of the responsibilities include:
Acting as a first point of contact with Regulatory authorities and import/customs offices
Being responsible for pre-certification and post-approval inquiries
Liaising between the Medical Device authority and foreign manufacturer in incident of Field Safety Corrective Action (FSCA), serious adverse event reporting to competent authorities, and in cooperation with manufacturer’s distributor