Before you begin…
开始之前…
You must obtain a device registration certificate or
certificate of free sale (CFS), or acceptable substitute, proving your product is approved for sale in your home market.
制造商必须获得原产国医疗器械注册证书或自由销售证书（CFS），或者其他可替代性文件，用以证明该产品已被批准在原产国市场销售。
Acceptable documents:
可接受文件：
l CFS from Home Market, consularized by Brazilian consulate
原产国的自由销售证书，经巴西领事馆认证
l INMETRO Certificate
INMETRO证书
l Proof of Marketing Approval in two other countries
除巴西以外，两个其他国家的上市许可证明
Step 1: Determine Device Classification
步骤1：判定器械类别
Class I Class II Class III Class IV
Devices are classified as Class I, II, III or IV
医疗器械分为I类，II类，III类，或IV类
Increasing risk to patient or user
增加患者或使用者的风险
l A smooth registration process in Brazil begins with
properly classifying your medical device using rules found
in Brazilian Resolution RDC 185/01 published by Brazilian medical device regulator ANVISA
在巴西，顺利的注册过程始于根据巴西医疗器械监管ANVISA发布的、巴西RDC 185/01决议建立的规则，对医疗器械进行正确分类
l Brazilian Resolution RDC 185/01 is fashioned similarly to the European Medical Device Directive (93/42/EEC)
巴西RDC 185/01决议类似于欧洲的医疗器械指令（93/42/EEC）
l Classes I, II, III and IV in Brazil are similar to Classes I, IIa, IIb and III in the European Union
巴西的I类，II类，III类和IV类，类似于欧盟的I类，IIa类，IIb类和III类
Step 2: Appoint Brazilian Registration Holder
步骤2：指定巴西注册代表
Manufacturers with no local presence in Brazil must
appoint a Brazil Registration Holder (BRH) to control
registration of their devices and liaise with ANVISA.
制造商在巴西不设有办事处的，须指定一个巴西注册代
表（BRH）操控注册过程并与ANVISA保持联系。
l Your BRH must hold a Company Working Allowanc
permit (IN 01/94) from ANVISA
所指定的BRH必须持有巴西国家卫生监督局颁发的公司工作
津贴许可（IN 01/94）
l These permits allow your BRH to import, distribute and sell your product in Brazil
这些许可证，使得BRH可以在巴西进口、批发和销售医疗器械
产品
l Manufacturers do not need to obtain permits themselves
制造商自身无需获得这些许可证
Step 3: INMETRO Product Certification
步骤3：巴西产品认证
l Some electronic medical devices must obtain INMETRO
certification in accordance with RDC 27/2011 as part of the Brazilian registration process.
部分有源医疗器械必须依据RDC 27/2011获得INMETRO认证，
用以作为巴西注册流程的一部分。
l Electrical safety testing conducted outside Brazil is
Acceptable if testing was performed by an International Laboratory Accreditation Program (ILAC)-certified laboratory and conducted less than two years ago.
在巴西以外进行的电子安全测试，除非是由国际实验室认可合作
组织（ILAC）实施并且是在最近两年内进行的，否则不予接受。
l INMETRO certification is valid for five years.
巴西国家认证有效期为五年。
Step 4: BGMP Compliance
步骤4:BGMP规则
l Some Class I and II manufacturers and all Class III and
IV manufacturers must comply with Brazilian Good
Manufacturing Practice (BGMP) quality system requirements
部分I类，II类和所有III类，IV类产品的制造商必须遵守巴西生产质量管理规范（BGMP）质量体系要求
l BGMP requirements are specified by RDC 59/2000
BGMP要求与RDC 59/2000相对应
l Brazilian quality system requirements resemble those
Of US Quality System Regulation 21 CFR Part 820
巴西质量体系要求与美国质量体系法规21CFR Part 820相类似
l Once BGMP compliance has been established, ANVISA conducts BGMP inspections every two years.
一旦BGMP规则建立起来，ANVISA每两年会进行一次BGMP检查。
l Manufacturers must self-audit every alternating
year.
制造商每隔一年应进行一次自审。
BGMP Exemptions
BGMP豁免
l Normative Instruction IN 2/2011
lists Class I and Class II devices that
must obtain BGMP certification
规范指令IN 2/2011列明I类和II类
设备必须取得BGMP认证
l Class I and II devices not listed on
IN 2/2011 are not required to obtain
BGMP certification
IN 2/2011中没列出的I类和II类
设备，不要求获得BGMP认证
l Qualifying firms go through an
abbreviated review process and
do not have to undergo BGMP recertifications or pay associated fees
复审合格的厂商，无需进行BGMP重新认证或支付相关费用
Step 5: Economic Information Reports and
Clinical Trial Requirements
步骤五：经济信息报告和临床试验要求
ANVISA requires Economic Information Reports (EIRs) for some devices
in accordance with RDC 185/06. EIRS include:
ANVISA依据RDC 185/06对某些设备要求经济信息报告（EIRs），
经济信息报告包括：
Pricing comparisons for other 病人/使用者信息；
Patient/user information markets 其他市场定价的对比；
Marketing materials 营销材料 ；
Other materials 其他材料；
Clinical trials: Highrisk and innovative devices must meet ANVISA clinical trial requirements. ANVISA usually accepts clinical trial results previously conducted in other markets as adequate to meet such requirements.临床试验：高风险和创新产品必须满足ANVISA临床试验要
求。ANVISA通常承认产品在其他国家进行过的临床试验结果。
Step 6: Technical File Preparation
步骤6：技术文件准备
l Technical files required by ANVISA resemble documents
required by the US FDA
ANVISA所要求的技术文件与美国FDA所要求的相类似
l Technical files should be prepared according to RDC 185/01 Annex III Part A/B/C and provided in Portuguese
应根据RDC 185/01附件三A/B/C部分要求准备并提供葡萄牙文版的技术文件
l Technical files should include information on device safety and effectiveness as well as product design data
技术文件须包括产品的安全性和有效性以及产品的设计资料
l Meet ANVISA labeling requirements, labeling must be provided in Portuguese
满足ANVISA标签要求，提供葡萄牙文版标签
l Firms that have already prepared Technical Files for CE Marking or US FDA 510(k) clearance may usually reuse that information to prepare their Brazilian Technical Files.
若之前有准备过CE或美国FDA510（k）技术文件的，通常可再用这些信息来准备巴西注册的技术文件
Step 7: Submit Registration Application to
ANVISA
步骤7：向巴西国家卫生监督局提交注册申请
l Your Brazilian Registration
Holder begins the process by
Submitting your registration
Application and Technical File
to ANVISA.
巴西注册代表从向ANVISA
提交注册申请和技术文件开始，
跟进注册过程。
l Registration fees are due to ANVISA upon submission of your application and Technical File documents.
注册费用由ANVISA根据所递交的注册申请和技术文件收取。
l The device registration process is controlled by your BRH.
产品注册过程由巴西注册代表进行跟进。
Step 8: ANVISA Review and Approval
步骤8：ANVISA审评和审批
l ANVISA registration reviews can take six to 12
Months for Class I, II and III devices, and longer for
Class IV devices.
I类，II类和III类设备的ANVISA注册审评长达
6-12个月，IV类设备的时间将更长。
l ANVISA registrations are valid for five years.
ANVISA认证有效期为五年。
Upon approval, ANVISA will publish your device’s registration number in the Diário Oficialda União 根据审批，ANVISA将在DiárioOficialda União公布产品注册号
Ongoing Compliance Issues
持续法规遵守
l ANVISA conducts on-site
BGMP audits every two
Years
ANVISA每两年进行一次
BGMP现场审核
manufacturers must
conduct self-inspections
and submit reports to
ANVISA
小年期间，制造商应进行自审并把报告提交到ANVISA
l Both ANVISA device registrations and INMETRO certifications must be renewed every five years
ANVISA器械认证和INMETRO认证都应每五年更新一次
Additional Resources
附加资源
PDF Chart of Brazil’s Regulatory Process:
巴西管理流程PDF图表：
http://www.emergogroup.com/literature
List of Brazilian regulatory documents:
巴西管理文件清单：
http://www.emergogroup.com/resources/regulations-brazil
Thank you for your time!
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