Medical Instrument Companies in Brazil

Brazil regulates medical devices under ANVISA's RDC 751/2022, with four risk classes:

• Class I and II: notification (notificação), with no technical review before the product is regularized; ANVISA can check documents or inspect later.
• Class III and IV: registration (registro), with a technical dossier and an ANVISA Brazilian GMP (B-GMP) certificate. Registration is valid for 10 years and renewable.

Only a Brazilian legal entity (a manufacturer or importer) can hold the notification or registration, so foreign manufacturers authorize a local holder. Labels and instructions must be in Portuguese, and some devices also need INMETRO conformity certification. See the medical certifications page.

Medical certifications

Only a Brazilian legal entity (a manufacturer or importer) can hold an ANVISA notification or registration (the "detentor"). The holder needs an ANVISA company operating authorization (AFE), files in its own name, communicates changes and keeps the technical dossier. The foreign manufacturer authorizes it through a consularized or apostilled declaration.

If your distributor is the holder, changing distributor can mean moving registrations. Many foreign manufacturers therefore use an independent holder so they can change distributors more freely. That is a commercial practice, not a legal requirement. Brazilian companies, currently more than 60, are listed on the Brazil country page.

Brazil

RDC 751/2022 requires labels and instructions for use in Portuguese. They must include the Brazilian holder's name and address and, where applicable, manufacturing and expiry dates. For reusable devices, the information must cover reprocessing: cleaning, disinfection, packaging, the re-sterilization method and any limit on the number of reuses.

Label artwork and IFU are submitted with the notification or registration petition. A manufacturer exporting to Brazil therefore needs validated reprocessing instructions translated into Portuguese before filing. Some devices also need INMETRO conformity certification, so check whether that applies. See the medical certifications page.

Medical certifications

For imported Class I and II notifications, RDC 751/2022 asks for a declaration from the legal manufacturer. It must authorize the Brazilian applicant and confirm knowledge of and compliance with B-GMP. It must be consularized or apostilled, in Portuguese, English or Spanish (or with a sworn translation), and no more than two years old if it states no validity. Class III and IV registrations also need proof of registration or free sale in the country of manufacture or sale.

Petitions missing mandatory documents can be refused without a technical query. Listed Brazilian companies are in cities such as São Paulo, Rio Claro and Ribeirão Preto; see the Brazil country page.

Brazil

Class I, under Rule 6 of Annex I to RDC 751/2022. Transient surgically invasive devices are Class II unless they are reusable surgical instruments (Class I) or meet higher-risk conditions, such as contact with the heart, central circulatory system or central nervous system, which can make them Class IV. Class I and II devices are notified rather than registered.

Note that RDC 751 defines reusable surgical instruments more widely than some other jurisdictions: the definition covers instruments that may or may not be connected to an active device. Where several rules apply, the strictest applies, and ANVISA may challenge the declared class. See the medical certifications page.

Medical certifications