Decoding ANVISA’s New Medical Device Regulations: How the 2025 Manual Reshapes Brazil Market Access Strategy ?

This article interprets the Manual for Registration of Health Products at ANVISA (Manual para Registro de Materiais de Uso em Saúde na ANVISA), published by the Brazilian Health Regulatory Agency (ANVISA) on December 17, 2025. Prepared by ANVISA’s Medical Device Technical Management Office (GEMAT), the manual consolidates recent regulatory updates to provide clear guidance on registration procedures for medical device manufacturers and importers. It incorporates key regulatory revisions, including RDC n° 751/2022, RDC n° 556/2021, and RDC n° 848/2024, with a focus on updates to risk classification, registration procedures, and safety requirements. Below, we detail the core revisions, key dates, and summarize essential guidelines for preparing application materials for manufacturers and importers.

I. Detailed Analysis of Core Revisions

The manual’s core revisions are based on the following ANVISA regulations, which have significantly adjusted the medical device registration framework:

1. Updated Risk Classification System (Based on RDC n° 751/2022)
   • Key Revision: RDC n° 751/2022, published on September 15, 2022, thoroughly reformed the risk classification system for medical devices. Devices are now categorized into Class I (low risk), Class II (medium risk), Class III (high risk), and Class IV (highest risk) based on inherent risks. Classes I and II are subject to a notification process (notificação), while Classes III and IV require full registration (registro).
   • Specific Rules: Classification follows 22 rules considering factors such as duration of use (transient, short-term, long-term), invasiveness (non-invasive, invasive, implantable), and device type (active devices, special devices, etc.). For example, Rule 8 stipulates that devices contacting the central circulatory or nervous systems are automatically classified as Class IV.
   • Impact: This revision enables finer classification granularity, requiring manufacturers to accurately assess product risks before application to avoid rejection.
2. Optimized and Digitized Registration Procedures
   • Key Revision: The manual emphasizes electronic submission as the sole channel via ANVISA’s Solicita or Peticionamento systems. New procedures introduce an “optimized analysis pathway” (procedimento otimizado), leveraging evaluations from equivalent foreign regulatory authorities (AREE) to expedite registration for Class III and IV devices (per IN n° 290/2024).
   • Critical Changes:
     • Unified Extended Validity: Per RDC n° 751/2022 effective September 2022, medical device registration certificates now have a unified validity period of 10 years (previously 5 years). The manual reaffirms and emphasizes this established rule.
     • Revalidation applications must be submitted 6–12 months before expiration.
     • Registration numbers are standardized to 11 digits (first 7 digits: AFE number; last 4 digits: serial number), enhancing traceability.
3. Enhanced Safety and Performance Requirements (Based on RDC n° 848/2024)
   • Key Revision: RDC n° 848/2024, published on March 6, 2024, clarifies that medical devices must meet essential safety and performance requirements (requisitos essenciais de segurança e desempenho). Manufacturers must submit a Technical File (Dossiê Técnico), including risk management reports, clinical evaluation data, and biocompatibility test results.
   • New Requirements: Innovative devices require specific clinical study data. Additionally, labels and instructions must include Unique Device Identification (UDI) information to enhance traceability.
4. Clarified Group and Family Registration (Based on RDC n° 556/2021)
   • Key Revision: This regulation allows similar devices to be grouped into families, systems, or sets for registration, reducing redundant applications. However, devices within a group must share identical design and intended use.
   • Important Note: If the family registration option is not selected during the initial application, it cannot be added later; a new application is required.

II. Release and Effective Dates

• Manual Release Date: Published by ANVISA in Brasília in 2025 as the latest guidance document, replacing previous versions.
• Key Regulations’ Release and Effective Dates:
  • RDC n° 751/2022: Released September 15, 2022, effective upon publication.
  • RDC n° 556/2021: Released August 30, 2021, effective immediately.
  • RDC n° 848/2024: Released March 6, 2024, effective upon publication.
  • IN n° 290/2024: Released April 4, 2024, governing the AREE optimized procedure.
• Implementation Note: While the manual itself is not legally binding, the referenced regulations carry full legal force. Companies must ensure compliance with the latest regulations to avoid application rejection or penalties.

III. Guidelines for Preparing Application Materials for Manufacturers and Importers

To correctly prepare registration applications, the manual provides clear guidelines covering the entire process from company registration to document submission:

1. Pre-requisites for Company Compliance
   • Operating Authorization (AFE): Manufacturers or importers must first obtain an AFE from ANVISA, certifying eligibility to engage in medical device activities. Applications are submitted electronically per RDC n° 16/2014.
   • Local Health License (LF): Companies must also obtain an operating license from the local health authority (VISA), ensuring facility compliance.
   • Good Manufacturing Practice Certificate (CBPF): For Class III and IV devices, a CBPF issued by ANVISA or at least a submission agreement is mandatory. Per RDC n° 687/2022, CBPF is a prerequisite for registration approval.
2. Core Document Checklist for Applications
   Applications must be submitted electronically. Key documents include (based on Technical File structure):
   • Application Form (Formulário de Petição): Must be fully completed with device name, model, risk classification, etc. The form cannot be modified; all fields must be accurate.
   • Technical File (Dossiê Técnico): Organized into 6 chapters:
     1. Administrative and technical information (e.g., company data, product identification).
     2. Detailed product description, global commercial history, and intended use.
     3. Safety and performance data: risk management report, physicochemical properties, biocompatibility tests (per ISO 10993), sterilization validation, etc.
     4. Clinical evidence summary compliant with IMDRF guidelines, demonstrating safety and efficacy.
     5. Label and instruction models, in Portuguese, including UDI information.
     6. Production flow chart outlining all steps from raw materials to finished product.
   • Additional Documents:
     • For imported devices: Manufacturer’s Authorization (authorizing Brazilian representative) and Free Trade Certificate (CLC), both notarized or apostilled, valid within 2 years.
     • Specific device requirements: e.g., implantable devices require UDI labels; sterile devices need sterilization method documentation.
3. Step-by-Step Application Process
   • Step 1: Complete company registration and profile setup via ANVISA’s system (cadastramento).
   • Step 2: Select the application subject code (Código de Assunto), e.g., “Solicitar Registro de Dispositivos Médicos,” and verify the document checklist.
   • Step 3: Submit the application electronically and pay the regulatory fee (TFVS), calculated based on company size and product type.
   • Step 4: After protocol submission, respond to any technical queries (exigência técnica) within 120 days to avoid application rejection.
   • Step 5: Upon approval, the registration is announced in the Federal Official Gazette (DOU), permitting market entry.
4. Common Errors and Avoidance Recommendations
   • Incomplete Documentation: Missing CBPF or clinical reports lead to direct rejection. Use ANVISA’s official checklist.
   • Incorrect Classification: Misclassification is a frequent cause of rejection. Companies should confirm classification via ANVISA’s consultation channels in advance.
   • Non-compliant Labeling: Instructions must align with the Technical File; avoid misleading information.

IV. Conclusion

The 2025 ANVISA manual consolidates critical regulatory updates, providing a clear strategic blueprint. Its core value lies in:

1. Elevating Service Standards and Efficiency
   Standardized requirements (e.g., electronic processes, AREE fast-track) enable the planning of more efficient registration pathways, significantly enhancing project success rates and timelines.
2. Deepening Professional Service Value
   Detailed Technical File and clinical evidence requirements elevate services from mere documentation assistance to comprehensive compliance partnership, ensuring product safety and efficacy.
3. Securing Client Market Access
   Mastery of the manual is central to reducing compliance risks and accelerating market access for clients. We will continue monitoring regulatory developments to ensure long-term compliance vitality for client projects.

In summary, this manual is a key tool for translating complex regulations into tangible competitive advantages for clients, supporting their steady growth in the Brazilian market.

If you require professional support and services, please do not hesitate to contact us.