ANVISA Medical Device Classification

The National Health Surveillance Agency is responsible for the registration of medical devices in Brazil and assigns a unique 11-digit identification number to each device, according to specific resolutions.

According to ANVISA, all medical devices are regulated by the Brazilian Ministry of Health, under Article 12 of Law No. 6360 of September 23, 1976, published in the Official Gazette of September 24, 1976. This Article regulates the manufacture, use, and sale of medical devices in Brazil.

All medical devices have to be registered and/or listed with ANVISA.

Listing is the first step in the registration process of all medical devices. This is a simple process that applies to medical devices classified according to the first paragraph of Article 25 of Law No. 6360 as Class I and Class II, which do not require registration under Resolution RDC ANVISA 24 of May, 1999.

On the other hand, some medical devices require registration, even if classified as Class I or Class II, because of the potential risk involved, as indicated in Resolution RDC ANVISA 185 of October 22, 1999, and other complementary regulations also used in this process.

The requirement for medical device registration and/or listing with ANVISA is determined by the classification of the device into four risk classes (I to IV) based on 18 classification rules. Classes I, II, III and IV represent low-, medium-, high- and very-high-risk devices, respectively.

Thus, medical devices classified as Class I and Class II may or may not require registration depending on their use, because they pose a low risk to the patient. Class III and Class IV devices require listing and registration, and all the parameters and specifications of the device have to be given during the registration process.

The classification rules for the registration of medical devices are based on the evaluation of risks arising from the application and use of the devices.