巴西作为南美洲最大的医疗器械市场和全球重要的新兴经济体，其医疗器械监管体系近年来经历了深度现代化改革，核心方向系向国际医疗器械监管论坛（International Medical Device Regulators Forum, IMDRF）的技术标准与监管逻辑全面对齐。巴西国家卫生监督局（Agência Nacional de Vigilância Sanitária, ANVISA）系依据1999年1月26日颁布的联邦法律第9.782号（Lei n 9.782, de 26 de janeiro de 1999）设立，在行政上关联于（vinculada）巴西卫生部，但作为特别自治公法人（autarquia sob regime especial）依法独立行使技术决策权，是负责医疗器械、药品、卫生用品等健康产品全链条监管的核心行政机构。

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.

在监管框架层面，2023年3月1日，第751号合议董事会决议（RDC n 751/2022）全面生效，取代了运行逾二十年的第185号合议董事会决议（RDC n 185/2001），成为巴西医疗器械一般监管的核心执行文件。2024年6月1日，第830号合议董事会决议（RDC n 830/2023）作为体外诊断（In Vitro Diagnostic, IVD）器械的专项法规正式生效。2024年9月4日，第848号合议董事会决议（RDC n 848/2024）正式生效，取代第546号合议董事会决议（RDC n 546/2021），系统更新了医疗器械与IVD的安全与性能基本要求。2026年3月1日，第426号规范性指令（IN n 426/2026）正式生效，标志着巴西医疗器械唯一器械标识（Unique Device Identification, UDI）系统进入强制实施阶段。

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.

本文聚焦于ANVISA的法律地位、现行核心法规架构及若干关键合规要点，旨在为拟进入巴西市场的中国医疗器械企业提供具有操作价值的法律指引。本系列后续各篇将分别就外国制造商的合规准入义务、商业与分销架构、本地授权代表制度、风险分类与准入路径等各项专题展开。

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系依据联邦法律第9.782/1999设立，该法系巴西卫生监督体系的基本法律，确立了ANVISA作为巴西国家卫生监督体系（Sistema Nacional de Vigilância Sanitária, SNVS）核心执行机构的法定地位。联邦法律第9.782/1999明确赋予ANVISA制定技术法规、评估和授权健康产品上市、监督生产与流通环节、监测不良事件、实施产品召回以及开展国际合作等全面监管权限。任何涉及医疗器械监管的规范性文件，包括合议董事会决议（Resolução da Diretoria Colegiada, RDC）、规范性指令（Instrução Normativa, IN）等，均须在联邦法律第9.782/1999的授权范围内制定，并不得与其上位规定相抵触。

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.

ANVISA在医疗器械领域行使的核心职能主要包括以下五个方面：

1.技术法规制定权。ANVISA有权制定与医疗器械安全、性能、标签、上市前评估及上市后监督相关的技术法规，以RDC决议为主要载体，具有普遍约束力。

2. 上市前审批权。ANVISA负责对拟在巴西境内上市的全部医疗器械进行风险评估和上市授权，依风险等级分别适用备案或注册程序。

3. 生产与流通监督权。ANVISA有权对医疗器械生产企业的良好生产规范（Boas Práticas de Fabricação, BPF）符合性进行审核与认证，并对进口产品的通关放行实施监管。

4. 上市后监测与执法权。ANVISA负责运行医疗器械不良事件监测系统，有权采取产品召回、暂停销售、撤销注册等行政措施。

5. 国际监管协调职能。ANVISA系IMDRF的正式成员，积极参与国际监管标准制定与协调工作，其法规体系以IMDRF的技术文件为重要参考依据。

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.

（一） RDC 751/2022：医疗器械通用核心法规 RDC 751/2022: General Core Regulation for Medical Devices

RDC 751/2022于2023年3月1日全面生效，取代了运行逾二十年的RDC 185/2001及RDC 40/2015等多部历史法规，标志着巴西医疗器械监管从分散立法走向体系化整合。该决议并非旧规的简单汇编，而是以IMDRF国际标准为参照系，对监管逻辑进行了系统性重构，从风险分类的底层规则，到技术文档的实质要求，再到上市后变更的动态管理，均在统一框架下形成闭环。

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.

在监管逻辑的起点上，RDC 751/2022采纳IMDRF分类体系，依据22条分类规则将医疗器械划分为Class I至Class IV四个风险等级。这一分类不仅是技术层面的分级，更具有程序法上的决定意义：Class I与Class II适用备案路径，体现对低中风险产品的程序简化；Class III与Class IV则须走注册路径，接受ANVISA的实质性审查。风险等级的高低，直接决定了准入程序的繁简与审评强度的大小。

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.

在技术审评层面，该法规对Class III和Class IV器械设定了完整的文档提交义务，要求按照IMDRF技术文档目录结构，向ANVISA提交涵盖安全性、性能、风险管理及临床评价等模块的完整技术档案。技术文档的实体标准并非由RDC 751/2022孤立设定，而是与RDC 848/2024形成衔接，后者进一步细化安全与性能基本要求（RGS），从生物相容性、电气安全、电磁兼容性到软件验证与风险管理，构建了多维度的技术合规基准。这一设计使分类规则、文档结构与实体标准三者环环相扣，形成了从“分到哪类”到“交什么材料”再到“达到什么标准”的完整监管链条。

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”.

在产品的全生命周期管理上，RDC 751/2022同样延伸了监管触角。一方面，该决议重申了标签与使用说明书的葡萄牙语强制要求，确保终端用户的可及性与监管的可执行性；另一方面，通过确立上市后变更管理制度，并配合IN 74/2020将变更细化为需事先批准、可立即实施但需备案、以及无需报告三类，使监管体系能够覆盖产品上市后的持续变化，而非止步于准入审批的一时之举。

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.

综上，RDC 751/2022并非零散规则的叠加，而是以风险分类为轴心，以技术文档要求与安全性能标准为两翼，以标签语言规则与变更管理制度为延展，构筑了一个逻辑自洽、层层递进的监管体系。

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.

（二） RDC 830/2023：IVD专项法规RDC 830/2023: IVD Special Regulations

RDC 830/2023于2024年6月1日正式生效，整合了此前分散在多部法规中的IVD相关规定，实现了IVD全类别风险分类与注册流程的统一。该法规采用双重风险评估框架，综合考虑对个人健康的风险和对公共健康的风险，将IVD分为Class I、Class II、Class III和Class IV四个风险等级。Class I和Class II适用备案路径，Class III和Class IV适用注册路径，注册证书有效期为10年。

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.

值得关注的是，该法规对部分产品的风险分类进行了调整：EB病毒（VEB）检测从Class II提升至Class IV，血红蛋白亚型从Class II提升至Class III，奈瑟菌、寨卡、衣原体、细小病毒（Parvovirus）、疟原虫（Plasmodium）等从Class III提升至Class IV。无指定值的对照品被新纳入IVD范畴并归类为Class II，相关企业须在法规生效后365天内完成备案。自测器械一般为Class III，但检测结果不用于判定危重临床状态的情形可为Class II；伴随诊断通常为Class III。

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.

（三） IN 426/2026：UDI系统与SIUD数据库IN 426/2026: UDI System and SIUD Database

2026年2月13日，ANVISA发布第426号规范性指令（IN n 426/2026），为巴西UDI数据库系统设定了详细的技术交付要求。该指令于2026年3月1日正式生效，标志着巴西UDI制度从框架确立阶段进入实质性运营阶段。

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.

UDI体系的核心架构包括：UDI-DI，系全球唯一识别器械型号的编码，须在SIUD数据库中公开提交；UDI-PI（生产标识符，Production Identifier），用于批次、序列号、有效期等生产信息的追溯，无需提交至SIUD数据库，仅需体现于器械载体（标签/包装）及企业内部的追溯记录中。SIUD数据提交的最后期限依据风险等级分阶段实施。

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.

此外，IN 426/2026对数据提交的技术要求进行了具体规范，比如支持在线表单填写、XML/JSON格式批量提交或机器对机器自动对接等多种提交模式、器械所有权变更须在30日内完成SIUD数据更新等。

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.

（四） IN 290/2024：AREE信赖路径IN 290/2024: AREE Reliance Pathway

2024年6月3日，ANVISA正式实施第290号规范性指令（IN n 290/2024），建立了“同等外国监管机构”（Autoridade Reguladora Estrangeira Equivalente, AREE）信赖机制。该机制旨在利用已获认可的境外监管机构的前置审评成果，加速巴西境内的注册审批流程。

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.

AREE适用范围限于Class III和Class IV的医疗器械及IVD产品。可接受的境外监管机构包括澳大利亚治疗用品管理局（TGA）、加拿大卫生部（Health Canada）、美国食品药品监督管理局（FDA）及日本厚生劳动省（MHLW）。

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).

需特别指出的是，AREE路径属于程序性加速机制而非实质性豁免机制：申请人仍须提交完整的技术文档，ANVISA的实质性技术评审不会因适用AREE路径而简化或跳过。据行业反馈，该路径可有效减少技术问询的轮次，从而缩短整体注册周期；但具体缩短幅度因产品与个案而异，ANVISA并未发布官方量化数据。

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.

外国制造商无法直接在ANVISA以自身名义提出注册或备案申请。依据巴西监管规则，任何拟在巴西境内上市的医疗器械，其注册证书或备案通知须以巴西境内的注册/备案持有人（detentor da notificação ou do registro，BRH）作为法定持证方。BRH是注册证书的法定权利人，承担与ANVISA之间的全部沟通义务，并对产品的上市后监督承担法定责任。在BRH选任策略上，建议制造商优先考虑独立的第三方BRH服务机构，避免将注册证书绑定于独家经销商。如将BRH与经销商身份重合，一旦经销商关系终止，注册证书的存续将面临重大不确定性，可能导致产品被迫退出巴西市场。独立的BRH安排有助于保持注册资产的中立性与稳定性。

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.

对于Class III和Class IV的医疗器械，ANVISA注册申请的审批以取得巴西良好生产规范认证为法定前置条件或并行条件。实务中，注册申请可与BPF认证同步推进，ANVISA亦允许在注册申请受理后补交BPF证书，但注册证书的最终颁发须以BPF认证通过为前提。对于已加入医疗器械单一审核计划（MDSAP）的生产企业，ANVISA 可直接采信MDSAP认证机构出具的审核报告与证书，从而免除自行实施BPF现场检查；同时，依据RDC 850/2024，此类企业的BPF证书有效期由一般的2年延长至4年（以持续维持MDSAP认证为条件），合规成本显著降低。

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.

除ANVISA注册及BPF认证外，特定类别的医疗器械还须取得其他政府机构的补充性强制认证，方可合法进口和上市销售：其一，纳入强制认证清单的有源（电）医疗器械——即依据第27号合议董事会决议（RDC n 27/2011）及第283号规范性指令（IN n 283/2024）列明、属于强制认证范围的电医疗设备——须获得巴西国家计量、标准化与工业质量研究所（Instituto Nacional de Metrologia, Qualidade e Tecnologia, INMETRO）颁发的电气安全认证，以证明产品符合适用的巴西电气安全技术标准；并非所有有源器械均需INMETRO认证，仅限前述法规清单所涵盖的品类。其二，含有无线通讯功能的医疗器械，还须获得巴西国家电信管理局（Agência Nacional de Telecomunicações, ANATEL）颁发的电信设备认证，以证明产品符合巴西无线电频谱管理与电磁兼容性要求。前述两项认证与ANVISA注册系相互独立的法定要求，企业在市场准入规划中须同步推进，避免因某一环节的缺失而延误整体上市时间表。

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.

巴西ANVISA医疗器械监管体系正经历向IMDRF国际标准的深度对齐与系统性升级。RDC 751/2022作为医疗器械一般监管的核心法规，RDC 830/2023作为IVD专项法规，连同IN 426/2026强制实施的UDI/SIUD系统，以及IN 290/2024推行的AREE信赖路径，共同构成了巴西医疗器械监管的最新法律框架。

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.

对于拟进入巴西市场的中国医疗器械企业，提出以下策略性建议：第一，持续跟踪ANVISA法规动态，特别是RDC 848/2024的安全与性能基本要求以及各法规的实施时间节点；第二，审慎遴选独立的BRH合作伙伴，确保注册资产的安全与稳定；第三，积极推进MDSAP认证，以延长BPF证书有效期并降低合规成本；第四，对于符合条件的Class III/IV产品，应充分利用AREE信赖路径，借助已获境外监管机构批准的既有成果加速巴西市场准入进程；第五，IVD产品生产企业须重点核查RDC 830/2023分类调整是否涉及自身产品线，确保在法定期限内完成合规调整。

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.