Before you begin…
開(kāi)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.
制造商必須獲得原產(chǎn)國(guó)醫(yī)療器械注冊(cè)證書(shū)或自由銷(xiāo)售證書(shū)（CFS），或者其他可替代性文件，用以證明該產(chǎn)品已被批準(zhǔn)在原產(chǎn)國(guó)市場(chǎng)銷(xiāo)售。
Acceptable documents:
可接受文件：
l CFS from Home Market, consularized by Brazilian consulate
原產(chǎn)國(guó)的自由銷(xiāo)售證書(shū)，經(jīng)巴西領(lǐng)事館認(rèn)證
l INMETRO Certificate
INMETRO證書(shū)
l Proof of Marketing Approval in two other countries
除巴西以外，兩個(gè)其他國(guó)家的上市許可證明
Step 1: Determine Device Classification
步驟1：判定器械類(lèi)別
Class I Class II Class III Class IV
Devices are classified as Class I, II, III or IV
醫(yī)療器械分為I類(lèi)，II類(lèi)，III類(lèi)，或IV類(lèi)
Increasing risk to patient or user
增加患者或使用者的風(fēng)險(xiǎn)
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，順利的注冊(cè)過(guò)程始于根據(jù)巴西醫(yī)療器械監(jiān)管ANVISA發(fā)布的、巴西RDC 185/01決議建立的規(guī)則，對(duì)醫(yī)療器械進(jìn)行正確分類(lèi)
l Brazilian Resolution RDC 185/01 is fashioned similarly to the European Medical Device Directive (93/42/EEC)
巴西RDC 185/01決議類(lèi)似于歐洲的醫(yī)療器械指令（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類(lèi)，II類(lèi)，III類(lèi)和IV類(lèi)，類(lèi)似于歐盟的I類(lèi)，IIa類(lèi)，IIb類(lèi)和III類(lèi)
Step 2: Appoint Brazilian Registration Holder
步驟2：指定巴西注冊(cè)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.
制造商在巴西不設(shè)有辦事處的，須指定一個(gè)巴西注冊(cè)代
表（BRH）操控注冊(cè)過(guò)程并與ANVISA保持聯(lián)系。
l Your BRH must hold a Company Working Allowanc
permit (IN 01/94) from ANVISA
所指定的BRH必須持有巴西國(guó)家衛(wèi)生監(jiān)督局頒發(fā)的公司工作
津貼許可（IN 01/94）
l These permits allow your BRH to import, distribute and sell your product in Brazil
這些許可證，使得BRH可以在巴西進(jìn)口、批發(fā)和銷(xiāo)售醫(yī)療器械
產(chǎn)品
l Manufacturers do not need to obtain permits themselves
制造商自身無(wú)需獲得這些許可證
Step 3: INMETRO Product Certification
步驟3：巴西產(chǎn)品認(rèn)證
l Some electronic medical devices must obtain INMETRO
certification in accordance with RDC 27/2011 as part of the Brazilian registration process.
部分有源醫(yī)療器械必須依據(jù)RDC 27/2011獲得INMETRO認(rèn)證，
用以作為巴西注冊(cè)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.
在巴西以外進(jìn)行的電子安全測(cè)試，除非是由國(guó)際實(shí)驗(yàn)室認(rèn)可合作
組織（ILAC）實(shí)施并且是在最近兩年內(nèi)進(jìn)行的，否則不予接受。
l INMETRO certification is valid for five years.
巴西國(guó)家認(rèn)證有效期為五年。
Step 4: BGMP Compliance
步驟4:BGMP規(guī)則
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類(lèi)，II類(lèi)和所有III類(lèi)，IV類(lèi)產(chǎn)品的制造商必須遵守巴西生產(chǎn)質(zhì)量管理規(guī)范（BGMP）質(zhì)量體系要求
l BGMP requirements are specified by RDC 59/2000
BGMP要求與RDC 59/2000相對(duì)應(yīng)
l Brazilian quality system requirements resemble those
Of US Quality System Regulation 21 CFR Part 820
巴西質(zhì)量體系要求與美國(guó)質(zhì)量體系法規(guī)21CFR Part 820相類(lèi)似
l Once BGMP compliance has been established, ANVISA conducts BGMP inspections every two years.
一旦BGMP規(guī)則建立起來(lái)，ANVISA每?jī)赡陼?huì)進(jìn)行一次BGMP檢查。
l Manufacturers must self-audit every alternating
year.
制造商每隔一年應(yīng)進(jìn)行一次自審。
BGMP Exemptions
BGMP豁免
l Normative Instruction IN 2/2011
lists Class I and Class II devices that
must obtain BGMP certification
規(guī)范指令IN 2/2011列明I類(lèi)和II類(lèi)
設(shè)備必須取得BGMP認(rèn)證
l Class I and II devices not listed on
IN 2/2011 are not required to obtain
BGMP certification
IN 2/2011中沒(méi)列出的I類(lèi)和II類(lèi)
設(shè)備，不要求獲得BGMP認(rèn)證
l Qualifying firms go through an
abbreviated review process and
do not have to undergo BGMP recertifications or pay associated fees
復(fù)審合格的廠商，無(wú)需進(jìn)行BGMP重新認(rèn)證或支付相關(guān)費(fèi)用
Step 5: Economic Information Reports and
Clinical Trial Requirements
步驟五：經(jīng)濟(jì)信息報(bào)告和臨床試驗(yàn)要求
ANVISA requires Economic Information Reports (EIRs) for some devices
in accordance with RDC 185/06. EIRS include:
ANVISA依據(jù)RDC 185/06對(duì)某些設(shè)備要求經(jīng)濟(jì)信息報(bào)告（EIRs），
經(jīng)濟(jì)信息報(bào)告包括：
Pricing comparisons for other 病人/使用者信息；
Patient/user information markets 其他市場(chǎng)定價(jià)的對(duì)比；
Marketing materials 營(yíng)銷(xiāo)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.臨床試驗(yàn)：高風(fēng)險(xiǎn)和創(chuàng)新產(chǎn)品必須滿足ANVISA臨床試驗(yàn)要
求。ANVISA通常承認(rèn)產(chǎn)品在其他國(guó)家進(jìn)行過(guò)的臨床試驗(yàn)結(jié)果。
Step 6: Technical File Preparation
步驟6：技術(shù)文件準(zhǔn)備
l Technical files required by ANVISA resemble documents
required by the US FDA
ANVISA所要求的技術(shù)文件與美國(guó)FDA所要求的相類(lèi)似
l Technical files should be prepared according to RDC 185/01 Annex III Part A/B/C and provided in Portuguese
應(yīng)根據(jù)RDC 185/01附件三A/B/C部分要求準(zhǔn)備并提供葡萄牙文版的技術(shù)文件
l Technical files should include information on device safety and effectiveness as well as product design data
技術(shù)文件須包括產(chǎn)品的安全性和有效性以及產(chǎn)品的設(shè)計(jì)資料
l Meet ANVISA labeling requirements, labeling must be provided in Portuguese
滿足ANVISA標(biāo)簽要求，提供葡萄牙文版標(biāo)簽
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.
若之前有準(zhǔn)備過(guò)CE或美國(guó)FDA510（k）技術(shù)文件的，通?？稍儆眠@些信息來(lái)準(zhǔn)備巴西注冊(cè)的技術(shù)文件
Step 7: Submit Registration Application to
ANVISA
步驟7：向巴西國(guó)家衛(wèi)生監(jiān)督局提交注冊(cè)申請(qǐng)
l Your Brazilian Registration
Holder begins the process by
Submitting your registration
Application and Technical File
to ANVISA.
巴西注冊(cè)代表從向ANVISA
提交注冊(cè)申請(qǐng)和技術(shù)文件開(kāi)始，
跟進(jìn)注冊(cè)過(guò)程。
l Registration fees are due to ANVISA upon submission of your application and Technical File documents.
注冊(cè)費(fèi)用由ANVISA根據(jù)所遞交的注冊(cè)申請(qǐng)和技術(shù)文件收取。
l The device registration process is controlled by your BRH.
產(chǎn)品注冊(cè)過(guò)程由巴西注冊(cè)代表進(jìn)行跟進(jìn)。
Step 8: ANVISA Review and Approval
步驟8：ANVISA審評(píng)和審批
l ANVISA registration reviews can take six to 12
Months for Class I, II and III devices, and longer for
Class IV devices.
I類(lèi)，II類(lèi)和III類(lèi)設(shè)備的ANVISA注冊(cè)審評(píng)長(zhǎng)達(dá)
6-12個(gè)月，IV類(lèi)設(shè)備的時(shí)間將更長(zhǎng)。
l ANVISA registrations are valid for five years.
ANVISA認(rèn)證有效期為五年。
Upon approval, ANVISA will publish your device’s registration number in the Diário Oficialda Uni?o 根據(jù)審批，ANVISA將在DiárioOficialda Uni?o公布產(chǎn)品注冊(cè)號(hào)
Ongoing Compliance Issues
持續(xù)法規(guī)遵守
l ANVISA conducts on-site
BGMP audits every two
Years
ANVISA每?jī)赡赀M(jìn)行一次
BGMP現(xiàn)場(chǎng)審核
manufacturers must
conduct self-inspections
and submit reports to
ANVISA
小年期間，制造商應(yīng)進(jìn)行自審并把報(bào)告提交到ANVISA
l Both ANVISA device registrations and INMETRO certifications must be renewed every five years
ANVISA器械認(rèn)證和INMETRO認(rèn)證都應(yīng)每五年更新一次
Additional Resources
附加資源
PDF Chart of Brazil’s Regulatory Process:
巴西管理流程PDF圖表：
http://www.emergogroup.com/literature
List of Brazilian regulatory documents:
巴西管理文件清單：
http://www.emergogroup.com/resources/regulations-brazil
Thank you for your time!
List of all global offices: www.emergogroup.com/contact
-
服務(wù)流程資料添加中....
- 官方收費(fèi)資料添加中....
- 基礎(chǔ)法規(guī)資料添加中....
- 相關(guān)服務(wù)資料添加中....
全國(guó)服務(wù)熱線：
