ANVISA (Brazil)Agência Nacional de Vigilância Sanitária

ANVISA (Agência Nacional de Vigilância Sanitária) is the Brazilian National Health Surveillance Agency — a federal autarchy linked to the Ministry of Health, created by Law 9.782/1999 with administrative + financial autonomy. Headquartered in Brasília with regional offices + permanent staff at major airports + ports + land borders. ANVISA's mandate covers the regulation, surveillance + enforcement of all 'health-surveillance products' supplied in Brazil.

ANVISA's scope is unusually broad by international standards: medicines (human + veterinary in part), medical devices + IVDs, biologicals + ATMPs, cosmetics + perfumes + personal-hygiene products, food (in coordination with MAPA — the Ministry of Agriculture), sanitizers + disinfectants, tobacco, blood + tissue + organ regulation, ionising-radiation services, ports + airports + borders sanitary surveillance, and aspects of clinical research approval (with CONEP).

Brazilian health surveillance is a tri-level system: ANVISA at federal level (norms + post-market for products in interstate / international commerce + CBPF inspections), state-level VISA (Vigilância Sanitária Estadual) covering state-internal commerce, and municipal-level VISA covering municipal services (pharmacies, clinics, restaurants). Most pharma + device manufacturing inspections are ANVISA-led with state VISA participation.

ANVISA is an ICH Regulatory Member since Nov 2016, a PIC/S member since 1 Jan 2021, a founding MDSAP regulator (since the MDSAP pilot in 2014 + the operational programme from 2017), an active ICMRA member, and the Mercosur reference + harmonisation lead through SGT-11 (Health Products Technical Subgroup) with Argentina, Paraguay, Uruguay + Bolivia.

Two structures gate the Brazilian market: the Brazilian Registration Holder (BRH / detentor de registro brasileiro) and the CBPF (Certificado de Boas Práticas de Fabricação — Good Manufacturing Practices Certificate).

• BRH — a Brazilian-domiciled legal entity that holds the ANVISA registration (registro) or notification (cadastro / notificação) and takes legal + regulatory responsibility for the product in Brazil. Non-Brazilian manufacturers either establish a Brazilian subsidiary BRH or contract with a third-party Brazilian Registration Holder. The BRH is the legal entity on which ANVISA enforcement actions, recalls, fines and post-market obligations attach.
• Responsável Técnico (RT) — every BRH must designate a Brazilian-licensed Technical Responsible (pharmacist, biologist, engineer, depending on product) registered with the relevant professional council (CRF, CRBio, CREA). The RT signs off on quality + regulatory submissions + is personally accountable for technical compliance.
• CBPF — mandatory GMP certificate issued by ANVISA after a satisfactory inspection of the manufacturing site (Brazilian or non-Brazilian). Required for all medicine + device + IVD manufacturers supplying the Brazilian market, valid 2 years (sometimes 4 for renewals from low-risk classes), renewable on re-inspection or via reliance routes.
• CBPF reliance routes — since the Aug 2023 RDC 786/2023 + subsequent updates, ANVISA can issue CBPF certificates by reliance on inspections by Mercosur partners, ICH regulators + PIC/S members in specified circumstances — significantly reducing duplicate-audit burden for sites with current EMA / FDA / Health Canada / TGA / PMDA / MHRA inspection outcomes.
• MDSAP for devices — ANVISA accepts MDSAP audit certificates as evidence for the QMS portion of CBPF for Class III + IV medical devices + IVDs from sites with current MDSAP certification, per ANVISA's MDSAP implementation framework.
• Authorisation of Operation (AFE) + Special Authorisation (AE) — separate from CBPF, every Brazilian company that manufactures, imports, distributes or commercialises health-surveillance products needs an AFE from ANVISA; for controlled substances (Portaria 344/1998 list) an additional AE is required.

Brazilian device regulation is the RDC 751/2022 + RDC 848/2024 (IUD) + RDC 665/2022 (GMP for devices + IVDs) framework — RDC 751/2022 fully replaced RDC 185/2001 for devices + RDC 36/2015 for IVDs from Mar 2023, aligning Brazil with IMDRF + EU MDR + GHTF principles.

• Class I — Lowest risk; subject to Notification (Cadastro) on the ANVISA Solicit system.
• Class II — Low-medium risk; subject to Notification (Cadastro) with technical-dossier review on demand.
• Class III — Medium-high risk; full Registration (Registro) with technical + safety + performance dossier.
• Class IV — Highest risk; full Registration (Registro) with the deepest technical-dossier review + sometimes clinical-evaluation review.
• Class IV examples include implantable cardiovascular devices, AIMD-equivalent, IVDs for severe communicable disease screening.
• CBPF requirement — Class III + IV require CBPF for the manufacturing site BEFORE Registration is granted (the 'CBPF first' rule); Class I + II do not require CBPF but the manufacturer must comply with RDC 665/2022 GMP.
• MDSAP option — for Class II + III + IV devices from manufacturers with current MDSAP certification, ANVISA accepts MDSAP as evidence for the QMS portion of CBPF assessment.
• IUD — Brazilian Unique Device Identifier under RDC 848/2024; phased implementation by risk class through 2026-2030; recognition of GS1, HIBCC + ICCBBA issuing agencies aligned with IMDRF.
• Clinical evidence — increasing emphasis on Brazilian-relevant clinical evidence + post-market clinical follow-up for Class III + IV devices.
• Reliance — RDC 845/2024 + related RDCs enable reliance on FDA + EMA + Health Canada + TGA + PMDA device approvals for selected device categories with reduced evaluation timeline.

• RDC 658/2022 — current GMP for medicines (replacing RDC 301/2019 + RDC 658/2022 update); substantively aligned with PIC/S GMP guide including Annexes 1 (sterile, 2022 revision), 11 (computerised systems), 15 (qualification + validation), 16 (certification + release), 17 (real-time release testing).
• RDC 665/2022 — GMP for medical devices + IVDs; substantively aligned with ISO 13485:2016 + IMDRF QMS principles; the foundation for CBPF for device manufacturers + MDSAP integration.
• RDC 786/2023 + reliance routes — formal framework for ANVISA reliance on inspections by Mercosur partners, ICH regulators + PIC/S members for CBPF + post-CBPF surveillance.
• PIC/S membership since 1 Jan 2021 — Brazil's accession after a multi-year strengthening programme; ANVISA inspectors now participate in PIC/S Joint Reassessment + JV inspections.
• ICH Regulatory Membership since Nov 2016 — Brazil progressively implements ICH guidelines via dedicated RDCs (Q7 / Q8 / Q9 / Q10 / Q11 / Q12 / E6 GCP / etc.).
• ANVISA Inspectorate — federal inspectors with delegated authority; international inspections of non-Brazilian sites are conducted in person + increasingly via remote / hybrid inspection methods.
• ALCOA+ + data integrity — ANVISA Inspectorate enforces data-integrity expectations substantively aligned with PIC/S PI 041 + MHRA 2018 + WHO + FDA expectations.
• Non-compliance + market action — CBPF non-renewal, ARTG-equivalent registration cancellation, infringement procedures (Auto de Infração) + administrative + financial sanctions; cases of severe non-compliance referred for criminal prosecution.

• RDC 406/2020 + RDC 657/2022 — current pharmacovigilance + risk-management framework for medicines; BRH must maintain a Brazilian pharmacovigilance system + designate a Brazilian Pharmacovigilance Responsible.
• VigiMed — ANVISA's national ICSR submission gateway; E2B(R3) format aligned with WHO + ICH; Brazil is a major contributor to WHO VigiBase via UMC Uppsala.
• Notivisa — ANVISA's broader health-surveillance notification system covering medicines, medical devices (technovigilance), blood (hemovigilance), cosmetics + food adverse-event reporting.
• Reporting timelines — SUSARs within 15 calendar days of BRH awareness; other serious + non-serious in periodic safety reports (Brazilian PSURs aligned with ICH E2C in substance).
• Risk Management Plan (RMP) — required for new + high-risk medicines + significant lifecycle changes; Brazilian-specific risk-minimisation considerations incorporated.
• Technovigilance — medical-device + IVD adverse-event reporting via Notivisa; field-safety corrective actions + recalls coordinated with the BRH + ANVISA's technovigilance unit (NUVIG).
• Hemovigilance — blood + blood-component adverse-event monitoring + post-transfusion safety.
• Recalls + market action — RDC 55/2005 + updates govern recall classification (Class I / II / III), execution + verification; ANVISA actively monitors recall completion + can escalate to mandatory recall + product seizure.
• Public-facing dashboards — ANVISA + Ministry of Health publish adverse-event dashboards + medicine + device safety alerts at the federal + state level.
• Vanessa's Law-equivalent — hospital + healthcare-setting reporting of serious device incidents is increasingly mandated through Notivisa + state-level health regulations.

• ICH Regulatory Member since Nov 2016 — ANVISA actively adopts ICH guidelines through dedicated RDCs covering quality, safety, efficacy + multidisciplinary topics.
• PIC/S member since 1 Jan 2021 — mutual recognition + reliance on PIC/S inspections of non-Brazilian sites.
• MDSAP founding regulator — single QMS audit accepted by ANVISA + FDA + Health Canada + TGA + PMDA.
• Mercosur SGT-11 — ANVISA leads Mercosur harmonisation on health products with Argentina (ANMAT), Paraguay (DINAVISA), Uruguay (MSP) + Bolivia (AGEMED); harmonised technical standards + reliance procedures.
• Reliance procedures — RDC 741/2022 + RDC 786/2023 + RDC 845/2024 + sector-specific RDCs enable reliance on EMA / FDA / Health Canada / TGA / PMDA / MHRA approvals + inspections.
• WHO collaboration — ANVISA is a WHO-recognised regulatory authority + participates in WHO Prequalification reviews for medicines + vaccines + IVDs; Bio-Manguinhos / Butantan + other Brazilian manufacturers are major WHO prequalified suppliers.
• ICMRA — Brazil is an active member contributing on pandemic preparedness, supply chain, AI / ML regulation + biosimilars.
• PRR-IF — Pharmaceutical Regulatory Reliance + Information-Sharing Forum participation.
• Bilateral memoranda + cooperation agreements — ANVISA holds active MoUs with FDA, EMA, Health Canada, MHRA, PMDA + many others enabling information exchange + cooperation.

• BRH not established or RT not properly designated + registered with the professional council — submissions rejected at intake.
• CBPF lapse — non-Brazilian manufacturing site supplying Brazil without a current CBPF; import refused at the border (Anvisa port-of-entry inspection).
• Reliance route eligibility misjudged — RDC 786/2023 + similar reliance procedures applied where source-regulator inspection scope or recency doesn't match Brazilian requirements.
• MDSAP scope gaps for CBPF — MDSAP audit doesn't cover Brazil-specific Class III / IV product requirements; supplementary CBPF inspection required.
• RDC 658/2022 GMP Annex 1 (sterile) implementation behind — manufacturers slow to implement the 2022 sterile-products revision adopted in Brazil through RDC 658/2022.
• Brazilian-specific labelling errors — bula (patient leaflet) + secondary packaging text not aligned with ANVISA-approved version; INN + brand name placement, generic yellow stripe + risk-pictogram errors.
• Notivisa / VigiMed submission late — beyond the 15-day SUSAR timeline; technovigilance reports not submitted via Notivisa.
• Brazilian RMP not maintained — Brazilian-specific risk-minimisation measures not reflected in updates.
• Class III / IV device CBPF-first sequencing violated — Registration applications filed before CBPF in place; application returned without review.
• IUD implementation behind schedule — RDC 848/2024 phased transitions not met for the device's risk class.
• AFE / AE lapse for Brazilian distributor / importer — distribution operations suspended pending renewal.
• Recall classification under RDC 55/2005 inconsistent with risk; execution + verification by VISA reveals products still in commerce.
• Clinical-trial application (DD) deficiencies — Brazilian-trial CONEP + ANVISA dual-review timelines misjudged; trial enrolment delayed.
• Importation licence (LI) on SISCOMEX errors — ANVISA-controlled product imported without proper LI; product detained at customs.
• Variation classification under RDC 73/2016 (medicines) + RDC 751/2022 (devices) misjudged — changes implemented without the correct ANVISA approval / notification level.

• Pre-submission meeting count + commitment-incorporation rate before standard / reliance / priority submission.
• Reliance pathway utilisation rate vs standard pathway.
• Evaluation cycle time vs target by pathway (365 days standard, reduced under reliance + priority).
• CBPF certificate continuity per Brazilian + non-Brazilian site.
• MDSAP + Conformity Assessment certificate continuity per device line.
• Class III + IV device 'CBPF-first' sequencing compliance.
• VigiMed + Notivisa on-time submission rate (15-day SUSAR + technovigilance).
• Brazilian PSUR + RMP on-time submission rate.
• Recall classification + execution timeline under RDC 55/2005.
• IUD implementation status per device line vs RDC 848/2024 phased transition.
• AFE / AE + RT registration freshness across Brazilian operating entities.
• Bula + Brazilian labelling freshness + alignment with ANVISA-approved version.
• ANVISA inspection outcome trend (CBPF, sectoral, surveillance inspections) per site.

V5 Ultimate runs the GMP + QMS + pharmacovigilance + technovigilance evidence layer underneath every ANVISA-regulated activity. Specifically:

• RDC 658/2022 + RDC 665/2022 + Annex 11 control framework — computerised-systems lifecycle, electronic-record + electronic-signature controls aligned with ICH + PIC/S expectations ANVISA Inspectorate enforces.
• CBPF inspection readiness — full document control, training, deviation, CAPA, change control, complaint, recall + post-market surveillance evidence pre-staged for federal + state inspector requests.
• MDSAP-ready QMS — ISO 13485-aligned controls + MDSAP-specific procedures + audit-evidence presentation accepted as alternative for CBPF QMS portion.
• BRH + RT workflows — Brazilian-domiciled registration holder + designated Responsável Técnico structure encoded at the workspace level with role-based controls + e-sig routing.
• Notivisa + VigiMed wiring — adverse-event capture (technovigilance + pharmacovigilance) with 15-day SUSAR + Notivisa submission packaging, E2B(R3)-ready content.
• IUD lifecycle — RDC 848/2024 issuing-agency selection (GS1 / HIBCC / ICCBBA), Brazilian UDI-DI + UDI-PI generation, label printing, IUD database submission, phased-transition tracking by risk class.
• Reliance-procedure packaging — RDC 741/2022 + RDC 786/2023 + RDC 845/2024 dossier-bridging support; cross-walk between EMA / FDA / Health Canada / TGA / PMDA approvals + Brazilian dossier requirements.
• Recall + URPTGA-equivalent execution — RDC 55/2005 classification + execution + verification workflows with state-level VISA coordination.
• Variation classification — RDC 73/2016 (medicines) + RDC 751/2022 (devices) variation tracking + approval / notification routing.
• Public-procurement alignment — REME / RENAME / SUS supply readiness for products subject to Brazilian public-health procurement, including data + reporting requirements for the SUS pipeline.
• Brazilian Portuguese localisation — Brazilian Portuguese-language label, bula, training + SOP packs with version control + ANVISA-approved-version traceability.
• Audit trail + e-signature — 21 CFR Part 11-equivalent + Brazilian electronic-signature law (Lei 14.063/2020 + ITI ICP-Brasil) compatible record-keeping for ANVISA + state VISA inspection use.