Brazilian Medical Device Regulatory System

Brazil possesses the largest medical device market in South America, and its regulatory system features unique characteristics from a global perspective.

Regulatory Authority: ANVISA

The central agency responsible for medical device regulation in Brazil is the National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, commonly known as ANVISA). Established in 1999, ANVISA is responsible for regulating pharmaceuticals, medical devices, cosmetics, food, and tobacco products. It can be understood as an institution comparable to Japan’s Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA).

Medical Device Classification

Brazil classifies medical devices into four classes based on risk:

Risk Class	Risk Level	Examples
Class I	Low risk	Bandages, hospital beds
Class II	Low-medium risk	Hypodermic needles, stethoscopes
Class III	Medium-high risk	Ventilators, implantable catheters
Class IV	High risk	Pacemakers, artificial heart valves

This classification is based on the classification rules in Annex VIII of the European Medical Device Regulation (MDR) No. 2017/745, as well as guidance from the International Medical Device Regulators Forum (IMDRF), and maintains a certain degree of international harmonization. The current classification framework is detailed in Resolution RDC 751/2022, which came into effect on March 1, 2023. This resolution includes specific classification rules (Rules 1-22) that address emerging technologies such as Software as a Medical Device (SaMD) (Rule 11) and devices containing nanomaterials (Rule 19).

Registration Process

To sell medical devices in Brazil, ANVISA registration is required. Since March 1, 2023, the registration terminology and requirements have been updated under RDC 751/2022.

Notificação (Notification) and Registro (Registration)

Brazil has two types of registration formats:

Notificação (Notification): Simplified registration system for Class I and Class II lower-risk devices

• The notification process is relatively simple and typically takes 30 days for ANVISA review
• Class I and II notifications do not expire and are exempt from renewal
• Manufacturers must maintain a complete technical dossier, but it is not submitted to ANVISA (kept on file for inspection purposes)

Registro (Registration): Full registration system for Class III and Class IV higher-risk devices

• Requires more detailed technical documentation and clinical data
• The review period ranges from 4 to 12 months depending on device type and submission quality
• Class III and IV registrations are valid for 10 years and must be renewed before expiration
• A complete technical file must be submitted to ANVISA

The technical dossier must be structured according to the IMDRF Table of Contents format as specified in Annex II of RDC 751/2022, which facilitates regulatory convergence and allows manufacturers to leverage documentation prepared for multiple jurisdictions.

Brazil-Specific Requirements

Brazilian Registration Holder (BRH)

Foreign manufacturers are required to establish a legal representative within Brazil. This representative serves as the contact point with ANVISA and is responsible for all regulatory-related operations, from product registration to post-market surveillance. The BRH (also referred to as “detentor” or license holder) is legally responsible for the device in the Brazilian market and coordinates all compliance activities, including import authorizations, registration maintenance, device recalls, and incident reporting.

INMETRO Certification

Many electrical medical devices are required to obtain certification from the National Institute of Metrology, Standardization and Industrial Quality (INMETRO). This certification demonstrates compliance with requirements for electrical safety and electromagnetic compatibility (EMC).

Medical devices requiring INMETRO certification include:

• Electrosurgical equipment
• Ventilators
• Anesthesia machines
• Infusion pumps
• Defibrillators
• Patient monitoring equipment
• Hemodialysis equipment
• Medical laser devices
• Ultrasonic diagnostic equipment
• X-ray diagnostic equipment
• MRI equipment
• Implantable electronic medical devices

Test reports from laboratories accredited by INMETRO or by members of internationally recognized forums such as IAAC (Inter-American Accreditation Cooperation) or ILAC (International Laboratory Accreditation Cooperation) are accepted for INMETRO certification. Testing performed outside Brazil is generally accepted, which can significantly reduce costs and time. The INMETRO certificate has indefinite validity, provided that the necessary maintenance audits are conducted. After ANVISA approval, devices must bear the INMETRO certification mark as a label. The maintenance and renewal process typically costs approximately $1,000 per certificate annually.

As of the 2024-2025 regulatory period, ANVISA has been working on updating Normative Instruction IN 116/2021, which governs the technical standards required for INMETRO certification. Once this revision is published, INMETRO certification bodies will immediately request updated test reports for the listed standards, and failure to provide these could result in cancellation of both the INMETRO certificate and the ANVISA registration.

In addition to medical devices, INMETRO certification is also required for consumer electronics (refrigerators, washing machines, air conditioners, etc.), information technology equipment, lighting fixtures, power tools, toys, and personal protective equipment.

ANATEL Certification

Some medical devices with wireless communication capabilities may also require certification from the National Telecommunications Agency (ANATEL). This certification demonstrates compliance with requirements for radio frequency spectrum use. Devices using Bluetooth, Wi-Fi, or other wireless communication technologies require ANATEL certification, similar to type approval processes in other countries. The device typically must be sent to Brazil for testing, and certification costs approximately $3,000-$4,000. Like INMETRO certification, ANATEL certification is required regardless of device class.

GMP Requirements

Manufacturing facilities must demonstrate compliance with Good Manufacturing Practices (GMP) for medical devices. Specifically for Class III and IV devices, Brazilian GMP (B-GMP) certification is required before registration approval. For foreign manufacturers, either an inspection by ANVISA or certification based on international mutual recognition agreements (MRA) is required.

According to RDC 687/2022, which came into effect for GMP certification processes, ANVISA accepts the protocol for applying for GMP certification at the time of registration application submission (as stated in Paragraph 2 of Article 14 of RDC 751/2022). However, final approval is contingent upon publication of a valid GMP certificate issued by ANVISA.

B-GMP certificates are valid for two years and must be renewed by the Brazilian Registration Holder at least six months before expiration. The ANVISA fee for B-GMP certification is BRL 72,804.90 (approximately $13,500 USD) per manufacturer. This represents a significant portion of the total registration costs.

As an alternative to ANVISA on-site inspection, manufacturers can participate in the Medical Device Single Audit Program (MDSAP). ANVISA recognizes MDSAP audit reports if Brazilian requirements have been taken into account. After the initial B-GMP certification, overseas manufacturers may provide a self-inspection report. Based on documental analysis (audit report within the scope of ISO 13485 and MDSAP), ANVISA may grant GMP recertification without requiring a re-inspection on-site for overseas manufacturers. When leveraging MDSAP certification, the B-GMP certificate validity extends to four years, significantly reducing the frequency and cost of recertification.

In January 2025, ANVISA published RDC 982/2025, which modernized Brazil’s regulatory framework by introducing a health risk-based model for GMP and GDP (Good Distribution Practices) certifications. This regulation adopts international audit equivalence principles, recognizing inspection reports from Authorities Recognized as Equivalent (AREE), PIC/S (Pharmaceutical Inspection Co-operation Scheme), IMDRF member countries, and MDSAP participants. This harmonization is expected to reduce redundancy in audits and accelerate market access for international manufacturers.

Post-Market Surveillance

Brazil operates a strict post-market surveillance system. Manufacturers are obligated to report medical device malfunctions and adverse events to ANVISA. In cases of serious problems, ANVISA has the authority to order product recalls. Post-market surveillance activities are coordinated through the National System of Health Surveillance (SNVS).

Additionally, Brazil has implemented a Unique Device Identifier (UDI) system based on RDC 591/2021, with implementation timelines as follows:

• Class IV devices: Compliance required as of July 2025
• Class III devices: Compliance required by January 10, 2026
• Class II devices: Compliance required by 2027
• Class I devices: Compliance required by 2028

RDC 884/2024 subsequently modified RDC 591/2021 to extend UDI implementation deadlines by one year for Class II, III, and IV devices. The Brazilian Registration Holder and manufacturers shipping devices to Brazil must closely monitor the ANVISA UDI database as this will impact the market significantly during the 2025-2026 period.

Recent Developments

In recent years, ANVISA has been strengthening its coordination with the International Medical Device Regulators Forum (IMDRF). Brazil officially joined MDSAP in 2016 to address the challenges of lengthy approval application processing times, particularly for high-risk class medical devices. The goal of joining MDSAP was to reduce the review burden for lower-risk devices and concentrate limited regulatory resources on reviewing higher-risk devices.

However, unlike other participating countries, ANVISA does not fully accept MDSAP audit reports without conditions and may require additional documentation or conduct independent inspections. Through such pilot participation, Brazil is actively pursuing international regulatory harmonization.

Regulatory Reliance and AREE Pathway

A significant development in 2024 was the introduction of regulatory reliance mechanisms. In April 2024, ANVISA published Normative Instruction IN 290/2024, based on RDC 741/2022, which permits manufacturers of Class III and IV medical devices and IVDs to leverage authorizations from Authorities Recognized as Equivalent (AREE). This reliance pathway commenced on June 3, 2024.

The scope includes devices already authorized by one of four AREEs:

• Australia Therapeutic Goods Administration (TGA)
• Health Canada
• U.S. Food and Drug Administration (FDA)
• Japan Ministry of Health, Labour and Welfare (MHLW)

To utilize this pathway, devices must be identical, have the same intended use and indications, and must not have been authorized under an abbreviated procedure. While manufacturers still must submit the complete technical dossier and other documents (such as the Essential Safety and Performance Requirements Checklist per RDC 848/2024) required by RDC 751/2022, leveraging AREE authorizations has resulted in significantly faster review times. The Brazil Registration Holder (or manufacturer in Brazil) submits an amendment after the initial registration submission. Experience indicates that when accepted by ANVISA, reviews through the reliance route are considerably swifter, and there is a reduced likelihood of receiving additional information requests from ANVISA regarding clinical data and performance testing.

Essential Safety and Performance Requirements

On March 6, 2024, ANVISA published RDC 848/2024, which updated the Essential Safety and Performance Requirements and revoked RDC 546/2021. This resolution came into force 180 days after publication (September 2024) and represents a significant harmonization effort with IMDRF guidance IMDRF/GRRP WG/N47FINAL:2018.

Importantly, the scope of RDC 848/2024 was expanded to include In Vitro Diagnostic medical devices (IVDs) in addition to general medical devices. Prior to this regulation, IVD manufacturers did not have to document compliance with explicit essential safety and performance requirements. Chapter II, Section IV of RDC 848/2024 is specific to IVDs only. The Essential Safety and Performance Requirements are now emphasized as pivotal throughout the entire lifecycle of the device or IVD, from initial conception to decommissioning and final disposal.

Medical device and IVD manufacturers must assess the additional requirements to ensure their products comply and update their Essential Safety and Performance Requirements checklists accordingly. This represents a new compliance burden for IVD manufacturers entering the Brazilian market.

Software as Medical Device and Digital Health

Following the COVID-19 pandemic, the regulatory framework for telemedicine devices and digital health solutions has been advanced. RDC 657/2022 provides specific instructions regarding Software as a Medical Device (SaMD), including defining exception regulatory situations, providing specific considerations about labeling, instructions for use, and safety and performance requirements. Rule 12 in RDC 751/2022 specifically addresses risk classification of SaMD.

As part of the 2024-2025 regulatory priorities, ANVISA has proposed a revision of RDC 657/2022 to include more specific regulatory document requirements, enhanced content about design verification, and comprehensive cybersecurity assessment requirements, reflecting the growing importance of cybersecurity in medical device safety.

E-Labeling and Instructions for Use

RDC 751/2022 permits e-labeling in non-printed format (“Formato Não Impresso”) according to Articles 50-54. However, Article 54 explicitly states that e-labeling is not permitted for devices intended for layperson use. One of ANVISA’s priority topics for 2024-2025 is to propose further legislation for electronic Instructions for Use (e-IFU) for medical devices intended for layperson use. This new legislation is expected to dictate the readability, format, and provision for access of e-IFUs.

Device Reprocessing Regulations

The topic of medical device reprocessing has been controversial in Brazil, and ANVISA has hosted several public consultations that have not yet yielded final legislation. Currently, a manufacturer’s self-declaration of “single-use” is insufficient. For a medical device to be qualified as “single-use,” the device material must either be listed in RE 2606/2006, or the manufacturer must submit objective evidence to support that the device cannot be reprocessed due to compromised cleaning, disinfection, or sterilization, as well as loss of performance, functionality, and integrity. ANVISA is expected to issue another public consultation to propose the removal of RE 2606/2006 and change the criteria to a risk-based approach supported by comprehensive documentation.

Certificate Issuance Modernization

In December 2024, ANVISA launched a new medical device certificate tool to replace the older Sicert system. Integrated with Solicita (ANVISA’s electronic submission system), the new platform offers updated templates, clearer layouts, translations, and certificate previews, enabling faster and more transparent issuance for manufacturers, importers, and distributors. Companies were required to transition from Sicert before December 1, 2025, when Sicert stopped issuing new certificates. Certificates can be validated via QR code or through ANVISA’s consultation system, improving security and reducing regulatory risk.

Key Considerations for Japanese Companies

Major challenges for Japanese companies entering the Brazilian market include:

Language Barrier: All application documents must be submitted in Portuguese. While some documents may be submitted in English or Spanish for certain procedures, all labeling, Instructions for Use, and many technical documents require Portuguese translation by sworn translators.

Time Constraints: Registration (Registro) in particular requires extended periods. For Class III and IV devices, the entire process including B-GMP certification can take 6-18 months. Even after obtaining MDSAP certification, there may be a 2-month wait for B-GMP certificate issuance. Class I and II notifications are relatively quick (approximately 30 days review time), but complete preparation including all ancillary certifications (INMETRO, ANATEL where applicable) must be factored in.

Certification Costs: In addition to registration fees, costs include Brazilian Registration Holder fees, INMETRO certification fees ($4,000-$6,000 per device), ANATEL certification if applicable ($3,000-$4,000), and B-GMP certification fees ($13,500 per manufacturer every 2-4 years depending on MDSAP status). For Class I/II devices, annual ongoing costs to the BRH range from $1,000-$2,000 per product. For Class III/IV devices, these annual costs increase to $1,500-$3,000 per product, not including B-GMP recertification expenses.

Domestic Manufacturing Preference Policy: Products manufactured within Brazil tend to receive preferential treatment. The new public procurement law (Law 14.133/2021) has expanded access for international companies to participate in public tenders, but registration through a Brazilian Registration Holder remains mandatory.

Post-Market Response: Adaptation to the strict post-market surveillance system is necessary. Brazilian Registration Holders must coordinate post-market surveillance activities, vigilance reporting, handling of device modifications, and responses to ANVISA inquiries. The UDI implementation requirements add another layer of compliance obligations beginning in 2025-2026.

Documentation Structure: The requirement to structure technical dossiers according to the IMDRF Table of Contents format (RDC 751/2022 Annex II) can actually benefit Japanese manufacturers, as documentation prepared for European MDR or other IMDRF-aligned jurisdictions can be leveraged, reducing duplication of effort.

Regulatory Reliance Opportunities: Japanese manufacturers with MHLW approval can leverage this authorization through the AREE reliance pathway for Class III and IV devices, potentially accelerating ANVISA review and reducing the burden of responding to additional information requests.

Summary

Brazil’s medical device market presents significant opportunities for international manufacturers, with a market projected to reach $7.3 billion by 2028, growing at a 5.1% CAGR. Approximately 69% of medical devices in the Brazilian market are imported, with major suppliers including China, the United States, and Europe. Recent regulatory modernization efforts, including the implementation of RDC 751/2022, regulatory reliance pathways, enhanced MDSAP recognition, and harmonization with IMDRF principles, have made market access more streamlined for manufacturers with existing authorizations in reference countries.

However, Brazil maintains country-specific requirements that demand careful attention, particularly regarding INMETRO and ANATEL certifications, Portuguese-language documentation, mandatory Brazilian Registration Holder representation, and B-GMP certification for higher-risk devices. Understanding these requirements and planning appropriately for timelines and costs is essential for successful market entry.

The ongoing regulatory evolution in Brazil, with active participation in IMDRF and increasing adoption of international harmonization principles, suggests continued improvements in regulatory efficiency while maintaining robust safety oversight. Companies that invest in understanding the Brazilian regulatory landscape and establish strong partnerships with experienced Brazilian Registration Holders are well-positioned to succeed in this important Latin American market.