巴西ANVISA RDC 751/2022：醫療器械風險分類規則與法規要求

If the wearable device does not make medical claims and is marketed strictly as a wellness or lifestyle product, it may fall outside the scope of medical device regulation in Brazil. However, if the product claims to monitor or diagnose medical conditions, ANVISA may classify it as a medical device and require registration or notification. Companies should carefully review labeling and intended use statements.

In Brazil, the Brazilian Registration Holder (often the local distributor or regulatory partner) plays a central regulatory role. The BRH submits the registration to ANVISA and manages communications with the authority. However, the manufacturer remains responsible for providing technical documentation, quality system evidence, and supporting post-market surveillance activities.

在巴西，如果软件具有诊断、监测或治疗相关的医疗用途，通常会被视为医疗器械（Software as a Medical Device）。ANVISA近年来对数字健康技术和AI医疗软件的监管讨论越来越多，因此企业在上市前应确认软件的风险分类，并准备技术文件和性能验证资料。

虽然CE认证不能直接替代巴西ANVISA的注册要求，但已有的国际认证（如CE或ISO 13485）通常可以作为技术文件的一部分提交，并有助于证明产品的安全性和质量体系。企业仍然需要按照巴西法规准备注册或备案资料。

Yes. Recent regulatory discussions in Brazil emphasize stronger post-market surveillance and vigilance requirements. When registering medical devices with ANVISA, manufacturers and their Brazilian Registration Holders (BRH) must maintain procedures for complaint handling, adverse event reporting, and traceability. These obligations are increasingly emphasized in regulatory updates, so companies entering Brazil should prepare robust post-market monitoring systems.

是的，在巴西註冊醫療器械通常需要一個本地的 Brazilian Registration Holder（BRH）。BRH 負責與 ANVISA 溝通、提交註冊申請、以及履行上市後監管義務。對於海外製造商來說，選擇合適且有經驗的 BRH 是進入巴西市場的重要一步。