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Medical Devices → Brazil

需 ANATEL、INMETRO、ANVISA；巴西市场准入需符合当地法规

Lead time 4-12 weeks
Cost range BRL 15,000-60,000
HS code 9018
Duty rate 14.0%
VAT / tax 17%

Technical standards

Reference standards for this product category — verify applicability with your testing lab before export.

Standard No.OrganizationTitleYear
ISO 14971:2019 ISO 医疗器械风险管理 2019
ISO 11607-1:2019 ISO 最终灭菌医疗器械包装 2019
ISO 10993-1:2018 ISO 医疗器械生物学评价 第1部分：风险管理中的评价与试验 2018
GB/T 48018-2026 GB/T 基本医疗保险登记服务规范 2026
GB/T 37977.61-2026 GB/T 静电学 第6-1部分：医疗、商业和公共场所的静电控制 医疗卫生 2026
GB/T 48017.1-2026 GB/T 医疗保障基础信息业务分类与编码 第1部分：通用要求 2026
GB/T 46857.1-2025 GB/T 医疗装备运维服务 第1部分：通用要求 2025
GB/T 19973.2-2025 GB/T 医疗产品灭菌 微生物学方法 第2部分：用于灭菌过程的定义、确认和维护的无菌试验 2025

Required certifications

CertificationWhat it coversStatus
ANATEL 通信设备 Required
INMETRO 电子电气/玩具/轮胎 Required
ANVISA 医疗/食品/化妆品 Required

Labeling requirements

Common non-compliance risks

Frequently asked

需要 巴西 税号吗？
B2C 销售通常需要注册当地税号，否则无法在平台销售。
认证周期多久？
一般 4-12 周，视产品复杂度。
费用大概多少？
参考 BRL 15,000-60,000，复杂产品更高。

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Full compliance report

Complete certification list, testing checklist and official source links — cross-verified with China-side requirements.

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