General overview of the brazilian regulatory framework. Brazils base regulations and medical device classification schemes are similar to those found in the european mdd 9342eec. Medical devices benefit patients by helping health care providers diagnose and treat patients. Anvisa is the authority responsible for medical devices in brazil. A guide to brazils medical device requirements nist. A medical device is any device intended to be used for medical purposes.
Anvisa medical device registration in brazil domo salute. In order to market medical devices in brazil you have to get previous approval from the brazilian health regulatory agency anvisa. Brazils anvisa launching notification pathway for lowrisk medical devices and ivds. I have a software product which i would like to sell in brazil. Medical software is a category of tools used in medical settings that collect data points on individual patient health for future reference, longterm study of behaviors, or shortterm diagnoses. Learn what is a software as a medical device samd and how to register it in the european union medical device regulation eu mdr 2017745 rule 11. Medical device registration and approval in brazil general countryspecific regulatory information is provided on this page for medical device registration and approval in brazil.
Medical device classification, anvisa, brazil registration. Premarket approvals for products categorized as risk class iii and iv are valid for ten years from the date of their publication in the brazilian official gazette, and. These devices will be audited for compliance and will need to submit a gmp certificate with their registration. We also can help you register your medical devices with anvisa. In this section you can find 442 medical device importers in brazil registered on our portal. Com user to receive detailed device specific compliance information for each market, including brazil, to expedite the preparation of your medical. Most devices that comply with these will comply with gmp. It shows you the definition of a medical device in europe and even in other countries like usa, brazil and china. Brazil medical device regulations anvisa guidelines.
Brazilian regulators prepare threetier medical device change. The companies are divided into importers for medical beddings, medical furniture, medical machines. All medical devices are required to comply with brazils good manufacturing practices gmp, which is similar to iso 485 and qsr. Anvisa will not conduct an audit of gmp compliance. Anvisa top medical device regulatory priorities for brazil heading.
In usa, its fda who is the health authority and who defines what is a medical device. However, manufacturers seeking to gain access to the brazilian market face. Non brazilian manufacturers need a local brazilian registration holder brh based in brazil. It is registered as a class 2 medical device by us fda. Thus what differentiates a medical device from an everyday device is its intended use. All medical devices in brazil are regulated by the brazilian health surveillance agency anvisa, medical devices are classified according to their risk, class i low risk to class iv high risk. Iii manufacturing site of software as a medical device samd. A guide for importing medical equipment into brazil. Gain market access in brazil with anvisa approval bsi. Working on regulations for the registration of software as a medical device samd in brazil. Software embedded in a medical device is referred to as. Anvisa class i medical device notification pathway to be.
It spends hugely on healthcare boosting the medical devices locally. Brazil is the largest medical device market in latin america, and it has a. This is the case, for example, with software devices and surgically invasive devices. Authorization of medical devices in brazil johner institute. Comprehensive list of medical device regulations for medical devices sold in brazil. The tools can be found in all sectors of the healthcare and medical. Adavium medical is a us venture capitalbacked company created to be the largest medical equipment and diagnostics company focused on brazil, the third largest private healthcare market in the world. Anvisa regulatory priorities for medical devices in 2020 global. Brazil is the largest medical device market in latin america, with an established but complex regulatory system. Brazil is the largest market for medical devices in south america. Is your medical device ready for the brazilian market. Medical is the international website for the worldwide medical industry. Access the brazilian market by meeting the requirements for your medical device.
This portal is an active b2b website for all medical device suppliers and their products like medical devices. The product performs qa for linear accelerators used in radiation therapy, but does not control or calibrate the accelerators and does not interact with patients in any way. Brazil medical device registration anvisa approval. In brazil, the institution that oversees medical device regulations is the brazilian national health surveillance agency anvisa the beginning of the medical device registration process requires the classification of the device according to the level of risk it poses to the human body. Guidance on what a software application medical device is and how to comply with the legal requirements. All medical devices in brazil are regulated by the brazilian health surveillance agency anvisa.