Brazil AFE Company Authorization under Decreto No. 8.077/2013: Who Can Apply and Entry Structures

1. Key takeaways

The company operating authorization (AFE, Autorização de Funcionamento de Empresa) can only be applied for by a legal entity legally established in Brazil; foreign manufacturers cannot obtain it themselves. The entity threshold is set jointly by Article 2 of Decreto n° 8.077/2013 (published August 14, 2013) and RDC n° 16/2014 (published April 1, 2014).

GRZAN’s judgment: AFE and product registration are two parallel preconditions, and holding an AFE does not clear the way for shipment. The frequent question of whether the AFE must be renewed periodically is also moot — RDC n° 860/2024 (published and effective May 8, 2024) has deleted the renewal provisions for AFE/AE.

2. Legal basis

• Company operating authorization and local sanitary licensing — Decreto n° 8.077/2013, signed August 14, 2013, published in the DOU and effective August 15, 2013 (Article 26), Articles 2, 3, 4, 5, 6, 7, 10 (§2), 23, 24 and 25
• Company operating authorization and special authorization — RDC n° 16/2014, published April 1, 2014, provisions on AFE scope; as amended by RDC n° 860/2024 (published and effective May 8, 2024)
• AFE rules for importing parts and accessories — RDC n° 939/2024, applicable from December 4, 2024, provisions exempting components from AFE
• Basic law on sanitary oversight of health products — Lei n° 6.360/1976, published September 23, 1976, Article 12

3. Expert insights

Why does Brazil lock the applicant to a domestic legal entity? GRZAN reads it as a matter of enforceability. Health supervision must find a responsible person and be able to act on site: Article 5 of Decreto n° 8.077/2013 requires a designated technical responsible person (RT, Responsável Técnico), Article 4 applies one certificate per address, and the whole design targets an entity verifiable inside the country.

GRZAN also flags a layer often ignored: the AFE must expressly state the activities the company intends to conduct and the product categories (Article 2 of Decreto n° 8.077/2013), and Article 3 conditions the authorization on conformity with Article 2 and with ANVISA’s specific rules. An AFE is therefore not a general business license; expanding into new product categories returns to the authorization level. Foreign parents stuffing new product lines directly into an existing AFE is one of the gaps GRZAN encounters most often.

Reading across the decree’s 26 articles, several more are frequently missed: Article 6 provides that although public institutions are exempt from the local licença, they remain bound by equivalent requirements; Article 10, §2 excludes imports for personal use without resale from the authorization — the compliant channel for samples and small trial batches; Article 23 requires notification to ANVISA at least 6 months before ceasing production or import, extendable to 12 months — companies planning an exit who ignore this will be pursued during withdrawal; Article 24 provides that violating the decree constitutes a sanitary offense under Lei n° 6.437/1977; Article 25 repeals Decreto n° 79.094/1977 and Decreto n° 3.961/2001; and Article 26 provides that publication in the DOU on August 15, 2013 is the effective date.

Only two landing structures result: establish a Brazilian legal entity to hold the AFE and import on its own license, or have a Brazilian importer or distributor that already holds an AFE handle the import stage. GRZAN’s advice is to choose by degree of control — the former costs more but stays in hand; the latter starts fast but leaves customers and registration documents in someone else’s keeping.

The first pitfall is conflating the AFE with product registration. Article 7 is explicit that products must first be registered with ANVISA; the AFE only settles whether the company may conduct the activity at all — without either, no shipment.

The second pitfall is the renewal wording. RDC n° 860/2024 deleted the AFE/AE renewal provisions and broadened exemptions; the AFE remains valid as long as local sanitary licenses are valid and the granted conditions are maintained. Internal documents still saying the AFE needs periodic renewal should be corrected at once. Note that this change concerns the AFE itself; product registration validity follows the 10-year rule of Article 11 of RDC n° 751/2022, and the two must not be applied to each other.

The third pitfall appears with components. RDC n° 939/2024 distinguishes two cases: importing components without their own registration is exempt from the AFE; accessories separately registered under RDC n° 751/2022 or RDC n° 830/2023 are treated as finished devices, and their import requires an AFE, with bonded warehouse storage requirements besides.

From the standpoint of responsibility allocation, the two structures differ beyond cost. With an own Brazilian entity, customs clearance, warehousing, technical vigilance and complaint response are all controllable; when a local importer is engaged, the registration holder and the importer are often different entities, and once a field action (Ação de Campo) or recall occurs, directives must travel through contract. GRZAN’s advice is to write into the agreement whose name reports vigilance events and executes recalls — not merely who pays.

4. Practical recommendations

• Lock the entity structure at initiation: establish a Brazilian legal entity, or contract with a local AFE-holding importer and settle ownership of the registration documents.
• State the intended activities and product categories expressly in the AFE application, finalizing the product list before filing.
• Check warehouse addresses against the one-certificate-per-address rule of Article 4; moving warehouses triggers license-level adjustments.
• Designate a qualified RT and fold the role into post-market vigilance and complaint response.
• Revise internal templates to delete periodic AFE renewal wording, replacing it with maintained granted conditions plus valid local licenses.
• Before cross-border delivery, re-verify under Article 7: product registration, AFE and local sanitary license must all stand together.
• Where a local licensed importer is used, name the registration holder, AFE holder and technical vigilance responsible party in the agreement, leaving no blank node in recall execution.

5. Verification checklist

• □ The applicant has been confirmed as a legal entity legally established in Brazil
• □ The one-certificate-per-address requirement of Article 4 of Decreto n° 8.077/2013 has been checked against warehouse arrangements
• □ An RT has been designated and appointment records kept (Article 5)
• □ Product registration with ANVISA has been confirmed complete (Article 7)
• □ AFE renewal wording has been removed from documents and RDC n° 860/2024 cross-checked

Regulatory information verified as of October 29, 2026.

GRZAN Regulatory Team

GRZAN provides registration and compliance support for medical device and IVD manufacturers entering the Brazilian market, covering AFE entity structuring, importer and distributor arrangements, local sanitary licensing and post-market compliance. For assistance with Brazilian regulatory requirements, contact info@grzanglobal.com.