As the largest medical device market in South America and a significant emerging global economy, Brazil's medical device regulatory system has undergone profound modernization reforms in recent years, with its core direction being comprehensive alignment with the technical standards and regulatory logic of the International Medical Device Regulators Forum (IMDRF). The Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária - ANVISA) was established pursuant to Federal Law No. 9.782 of January 26, 1999. Administratively linked to the Brazilian Ministry of Health, it operates independently as a special autonomous public entity exercising technical decision-making authority by law. It is the core administrative body responsible for the full-chain regulation of health products, including medical devices, pharmaceuticals, and health supplies.

At the regulatory framework level, on March 1, 2023, Collegiate Board Resolution No. 751 (RDC n 751/2022) came into full effect, replacing the over-two-decades-old Collegiate Board Resolution No. 185 (RDC n 185/2001) and becoming the core implementing document for the general regulation of medical devices in Brazil. On June 1, 2024, Collegiate Board Resolution No. 830 (RDC n 830/2023) officially took effect as the specific regulation for In Vitro Diagnostic (IVD) devices. On September 4, 2024, Collegiate Board Resolution No. 848 (RDC n 848/2024) officially took effect, replacing Collegiate Board Resolution No. 546 (RDC n  546/2021) and systematically updating the essential safety and performance requirements for medical devices and IVDs. On March 1, 2026, Normative Instruction No. 426 (IN n 426/2026) became effective, marking the mandatory implementation phase of Brazil's Unique Device Identification (UDI) system.

This article focuses on the legal status of ANVISA, the current core regulatory framework, and several key compliance points, aiming to provide Chinese medical device enterprises intending to enter the Brazilian market with practical legal guidance. Subsequent articles in this series will separately address topics such as the compliance access obligations for foreign manufacturers, commercial and distribution structures, the local authorized representative system, risk classification and access pathways, among others.

ANVISA was established pursuant to Federal Law No. 9.782/1999, which is the fundamental law of Brazil’s health surveillance system, establishing ANVISA’s statutory position as the core executive body of the Brazilian National Health Surveillance System (Sistema Nacional de Vigilância Sanitária, SNVS). Federal Law No. 9.782/1999 explicitly grants ANVISA comprehensive regulatory powers, including formulating technical regulations, evaluating and authorizing the marketing of health products, supervising production and distribution channels, monitoring adverse events, implementing product recalls, and engaging in international cooperation. Any normative documents involving medical device regulation, including Collegiate Board Resolutions (Resolução da Diretoria Colegiada, RDC) and Normative Instructions (Instrução Normativa, IN), must be formulated within the authorization scope of Federal Law No. 9.782/1999 and must not conflict with its superior provisions.

The functions exercised by ANVISA in the field of medical devices mainly include the following five aspects:

1.First, the power to formulate technical regulations. ANVISA has the authority to formulate technical regulations related to the safety, performance, labeling, pre-market evaluation, and post-market surveillance of medical devices, primarily issued as RDC resolutions, which are universally binding.

2. Second, pre-market approval power. ANVISA is responsible for conducting risk assessments and granting marketing authorization for all medical devices intended to be marketed in Brazil, applying notification or registration procedures according to their risk classification.

3. Third, production and distribution supervision power. ANVISA has the authority to audit and certify the compliance of medical device manufacturing enterprises with Good Manufacturing Practices (Boas Práticas de Fabricação - BPF), and to supervise the customs clearance and release of imported products.

4. Fourth, post-market surveillance and enforcement power. ANVISA is responsible for operating the medical device adverse event monitoring system and has the authority to take administrative measures such as product recalls, sales suspensions, and registration revocations.

5. Fifth, international regulatory coordination function. ANVISA is a full member of the IMDRF and actively participates in the development and coordination of international regulatory standards. Its regulatory system uses IMDRF technical documents as important reference materials.

（1) RDC 751/2022: General Core Regulation for Medical Devices

RDC 751/2022 came into full effect on March 1, 2023, replacing the over-two-decades-old RDC 185/2001 and several other historical regulations like RDC 40/2015, marking Brazil's transition from fragmented legislation to a systematic integration of medical device regulation. This resolution is not a simple compilation of old rules but represents a systematic reconstruction of the regulatory logic with reference to IMDRF international standards, forming a closed loop under a unified framework, from the underlying rules of risk classification to the substantive requirements of technical documentation, and further to the dynamic management of post-market changes.

At the starting point of regulatory logic, RDC 751/2022 adopts the IMDRF classification system, dividing medical devices into four risk classes from Class I to Class IV based on 22 classification rules. This classification is not only a technical grading but also has decisive significance in procedural law: Class I and Class II follow the notification pathway, reflecting the procedural simplification for low-to-medium risk products; Class III and Class IV must undergo the registration pathway, subject to substantive review by ANVISA. The level of risk directly determines the complexity of the access procedure and the depth of the review.

At the technical review level, this regulation sets forth comprehensive documentation submission obligations for Class III and Class IV devices, requiring submission of a complete technical file covering safety, performance, risk management, and clinical evaluation modules to ANVISA according to the IMDRF technical documentation directory structure. The substantive standards for technical documentation are set not only by RDC 751/2022 but also by RDC 848/2024, the latter further detailing the Essential Safety and Performance Requirements (RGS), establishing multi-dimensional technical compliance benchmarks from biocompatibility, electrical safety, electromagnetic compatibility to software validation and risk management. This design interlinks the classification rules, documentation structure, and substantive standards, forming a complete regulatory chain from “which class it falls into” to “what materials to submit” and finally to “what standards to meet”.

Regarding the full life-cycle management of products, RDC 751/2022 also extends its regulatory reach. On one hand, the resolution reiterates the mandatory Portuguese language requirement for labels and instructions for use, ensuring accessibility for end-users and enforceability of regulation; on the other hand, by establishing a post-market change management system and coordinating with IN 74/2020 to categorize changes into those requiring prior approval, those that can be implemented immediately but require notification, and those that require no report, the regulatory system can cover ongoing changes after product marketing, rather than stopping at the one-time approval for market access.

In summary, RDC 751/2022 is not an aggregation of scattered rules but constructs a logically self-consistent and progressively layered regulatory system with risk classification as its axis, technical documentation requirements and safety-performance standards as its two wings, and labeling language rules and change management systems as its extensions.

（2） RDC 830/2023: IVD Special Regulations

RDC 830/2023 officially took effect on June 1, 2024, consolidating previously scattered IVD regulations from multiple laws and achieving unified risk classification and registration processes for all IVD categories. This regulation adopts a dual risk assessment framework, comprehensively considering risks to individual health and public health, classifying IVD into four risk levels: Class I, Class II, Class III, and Class IV. Class I and Class II are subject to the notification path, while Class III and Class IV are subject to the registration path. The registration certificate is valid for 10 years.

It is noteworthy that this regulation adjusted the risk classification for some products: Epstein-Barr virus (EBV) detection was elevated from Class II to Class IV, hemoglobin subtypes from Class II to Class III, and Neisseria, Zika, Chlamydia, Parvovirus (Parvovirus), Plasmodium (Plasmodium) etc., from Class III to Class IV. Control materials without assigned values were newly included in the IVD scope and classified as Class II. Relevant enterprises must complete notification within 365 days after the regulation takes effect. Self-test devices are generally Class III, but can be Class II if the test results are not used to determine critical clinical status; companion diagnostics are usually Class III.

（3） IN 426/2026: UDI System and SIUD Database

The legal basis for Brazil's UDI regime is Collegiate Board Resolution No. 591 (RDC n 591/2021), which in December 2021 established the Unique Device Identification (UDI) system and the framework for Brazil’s UDI database (Sistema de Identificação Única de Dispositivos Médicos, SIUD), setting a phased mandatory implementation timeline by risk class (subsequently extended by RDC n 884/2024). On February 13, 2026, ANVISA issued Normative Instruction No. 426 (IN n 426/2026), setting detailed technical delivery requirements for the SIUD database and bringing it into actual operation. This instruction officially took effect on March 1, 2026, marking the transition of the Brazilian UDI system from the framework establishment phase to the substantive operation phase.

The core architecture of the UDI system includes: UDI-DI, a globally unique code identifying the device model, which must be publicly submitted in the SIUD database; UDI-PI (Production Identifier, Production Identifier), used for tracing production information such as batch number, serial number, expiration date, etc., does not need to be submitted to the SIUD database, and only needs to be reflected on the device carrier (label/packaging) and within the enterprise's internal traceability records. SIUD data submission deadlines are implemented in phases according to risk levels.

Furthermore, IN 426/2026 specifically regulates the technical requirements for data submission, such as supporting multiple submission modes like online form filing, XML/JSON format batch submission, or machine-to-machine automatic interface, device ownership changes must be completed within 30 days after the entry into force of the specific Resolutions on registration cancellation and transfer of ownership.

（4）IN 290/2024: AREE Reliance Pathway

On August 10, 2022, ANVISA issued Collegiate Board Resolution No. 741 (RDC n 741/2022), establishing the general criteria and reliance framework for leveraging prior assessments by an “Equivalent Foreign Regulatory Authority” (Autoridade Reguladora Estrangeira Equivalente, AREE). Building on this framework, on April 8, 2024, ANVISA issued Normative Instruction No. 290 (IN n 290/2024), which specifically implements this reliance mechanism for medical devices; it officially took effect on June 3, 2024.

The AREE scope of application is limited to Class III and Class IV medical devices and IVD products. Acceptable foreign regulatory authorities include the Australian Therapeutic Goods Administration (TGA), Health Canada (Health Canada), the U.S. Food and Drug Administration (FDA), and the Japanese Ministry of Health, Labour and Welfare (MHLW).

It is particularly important to note that the AREE pathway is a procedural acceleration mechanism rather than a substantive exemption mechanism: applicants must still submit complete technical documentation, ANVISA’s substantive technical review will not be simplified or skipped due to the application of the AREE pathway. According to industry feedback, this pathway can effectively reduce the number of technical inquiry rounds, thereby shortening the overall registration cycle; however, the specific shortening extent varies by product and case, and ANVISA has not released official quantitative data.

Foreign manufacturers cannot directly apply for registration or notification in their own name with ANVISA. According to Brazilian regulatory rules, for any medical device intended to be marketed in Brazil, its registration certificate or notification must be held by a Brazilian-based registration/notification holder (detentor da notificação ou do registro, BRH) as the legal certificate holder. BRH must have a license issued by ANVISA to manufacture or import medical devices, accordingly. BRH is the legal rights holder of the registration certificate, bears all communication obligations with ANVISA, and bears statutory responsibility for post-market surveillance of the product. Regarding the BRH selection strategy, it is recommended that manufacturers prioritize independent third-party BRH service providers, avoiding binding the registration certificate to an exclusive distributor. If the BRH identity overlaps with the distributor, once the distributor relationship terminates, the continuation of the registration certificate will face significant uncertainty, potentially forcing the product to withdraw from the Brazilian market. An independent BRH arrangement helps maintain the neutrality and stability of the registration asset.

For Class III and Class IV medical devices, approval of the ANVISA registration application is conditional upon obtaining Brazilian Good Manufacturing Practice certification as a statutory prerequisite or parallel condition. In practice, the registration application can be advanced concurrently with BPF certification; ANVISA also allows submission of the BPF certificate after the registration application is accepted, but the final issuance of the registration certificate is subject to passing BPF certification. For manufacturing facilities that have joined the Medical Device Single Audit Program (MDSAP), ANVISA can directly accept the audit reports and certificates issued by MDSAP certification bodies, thereby exempting them from conducting their own BPF on-site inspections; simultaneously, according to RDC 850/2024, the BPF certificate validity period for such enterprises is extended from the general 2 years to 4 years (conditional upon continuously maintaining MDSAP certification), significantly reducing compliance costs.

In addition to ANVISA registration and BPF certification, specific categories of medical devices must also obtain supplementary mandatory certifications from other government agencies before they can be legally imported and marketed: First, active (electrical) medical devices included in the mandatory certification list -  that is, those covered under Collegiate Board Resolution No. 549 (RDC n 549/2021, which establishes the current framework making mandatory certification a prerequisite for medical device registration or notification) and Normative Instruction No. 283 (IN n 283/2024, in force since April 1, 2024, replacing former IN n 116/2021, listing applicable technical standards such as the ABNT NBR IEC 60601 series) — must obtain electrical safety certification from the Brazilian National Institute of Metrology, Standardization and Industrial Quality (Instituto Nacional de Metrologia, Qualidade e Tecnologia - INMETRO) to prove the product complies with applicable Brazilian electrical safety technical standards; not all active devices require INMETRO certification, only the categories covered by the aforementioned regulatory list. Second, medical devices containing wireless communication functions must also obtain telecommunications equipment certification from the Brazilian National Telecommunications Agency (Agência Nacional de Telecomunicações - ANATEL) to prove the product complies with Brazilian radio spectrum management and electromagnetic compatibility requirements. The aforementioned two certifications and ANVISA registration are mutually independent statutory requirements. Enterprises must advance them simultaneously in their market access planning to avoid delaying the overall launch schedule due to the absence of any one link.

Brazil’s ANVISA medical device regulatory system is undergoing deep alignment with IMDRF international standards and a systematic upgrade. RDC 751/2022 as the core regulation for general medical device regulation, RDC 830/2023 as the IVD special regulation, together with the UDI/SIUD system mandatorily implemented by IN 426/2026, and the AREE reliance pathway implemented by IN 290/2024, collectively constitute the latest legal framework for medical device regulation in Brazil.

For Chinese medical device enterprises intending to enter the Brazilian market, the following strategic suggestions are proposed: First, continuously track ANVISA regulatory developments, especially the safety and performance essential requirements of RDC 848/2024 and the implementation timelines of various regulations; Second, carefully select independent BRH partners to ensure the security and stability of registration assets; Third, actively promote MDSAP certification to extend the BPF certificate validity period and reduce compliance costs; Fourth, for eligible Class III/IV products, fully utilize the AREE reliance pathway, leveraging existing results approved by foreign regulatory authorities to accelerate the Brazilian market access process; Fifth, IVD product manufacturers must focus on checking whether the RDC 830/2023 classification adjustments involve their own product lines, ensuring compliance adjustments are completed within the statutory period.