Before you begin…
開始之前…
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國醫療器械注冊證書或自由銷售證書（CFS），或者(zhe)其他可替代性文件(jian)，用以證(zheng)明該產(chan)品已被批(pi)準在(zai)原(yuan)產(chan)國市場(chang)銷售。
Acceptable documents:
可接受文件：
l CFS from Home Market, consularized by Brazilian consulate
原產國的自由銷售證書，經巴西領事館(guan)認證
l INMETRO Certificate
INMETRO證書(shu)
l Proof of Marketing Approval in two other countries
除巴西以外(wai)，兩個其他(ta)國家的上市許可證明(ming)
Step 1: Determine Device Classification
步驟1：判定器械類別
Class I Class II Class III Class IV
Devices are classified as Class I, II, III or IV
醫療器械分為I類，II類，III類，或IV類(lei)
Increasing risk to ;patient or user
增加患者(zhe)或使用(yong)者(zhe)的風(feng)險
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，順利的注冊過程始于根據巴西醫療器械監管ANVISA發布的、巴西(xi)RDC 185/01決議建(jian)立的規則，對醫(yi)療(liao)器械進行正確分類
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(lei)似于(yu)歐(ou)洲的(de)醫(yi)療器械指(zhi)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(lei)，II類，III類和(he)IV類(lei)(lei)，類(lei)(lei)似于歐盟的I類，IIa類，IIb類和(he)III類
Step 2: Appoint Brazilian Registration Holder
步驟2：指定巴(ba)西注冊代(dai)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(zao)商(shang)在巴西(xi)(xi)不設有辦事處的，須指定(ding)一個巴西(xi)(xi)注冊代
表（BRH）操控注冊過程并與ANVISA保持聯系。
l Your BRH must hold a Company Working Allowanc
permit (IN 01/94) from ANVISA
所指定的BRH必須持有巴西國家衛(wei)生監督(du)局(ju)頒發的公司工作
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(jin)口、批發(fa)和銷售醫療器械
產品
l Manufacturers do not need to obtain permits themselves
制(zhi)造商自(zi)身無需獲得這些(xie)許可證
Step 3: INMETRO Product Certification
步驟3：巴西(xi)產品(pin)認(ren)證
l Some electronic medical devices must obtain INMETRO
certification in accordance with RDC 27/2011 as part of the Brazilian registration process.
部分有源醫療器械必須依據RDC 27/2011獲得INMETRO認證，
用以作(zuo)為巴西注冊流(liu)程的(de)一部分(fen)。
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(ba)西以外進(jin)行的(de)電子安全測試，除非是(shi)由國際(ji)實驗室認可合作
組織（ILAC）實施并且是在最(zui)近兩年內(nei)進行的，否則不予接受。
l INMETRO certification is valid for five years.
巴西(xi)國家認證有效期為五年(nian)。
Step 4: BGMP Compliance
步驟4:BGMP規則
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(lei)，II類和(he)所(suo)有(you)III類，IV類產(chan)品的制(zhi)造商必須遵守巴(ba)西生產(chan)質量管理規范（BGMP）質量(liang)體系(xi)要求
l BGMP requirements are specified by RDC 59/2000
BGMP要求(qiu)與RDC 59/2000相(xiang)對應(ying)
l Brazilian quality system requirements resemble those
Of US Quality System Regulation 21 CFR Part 820
巴西質量體系要求與美國質量體系法規21CFR Part 820相類似(si)
l Once BGMP compliance has been established, ANVISA conducts BGMP inspections every two years.
一旦BGMP規則建立起來(lai)，ANVISA每兩年會進行(xing)一(yi)次BGMP檢查(cha)。
l Manufacturers must self-audit every alternating
year.
制造商每隔一年(nian)應(ying)進行一次自審。
BGMP Exemptions
BGMP豁(huo)免
l Normative Instruction IN ;2/2011
lists Class I and Class II devices that
must obtain BGMP certification
規范指令IN 2/2011列明I類和II類
設備必須取得BGMP認證
l Class I and II devices not listed on
IN 2/2011 are not required to obtain
BGMP certification
IN 2/2011中沒列(lie)出的I類和II類
設備，不要求獲得BGMP認證
l Qualifying firms go through an
abbreviated review process and
do not have to undergo BGMP recertifications or pay associated fees
復審合格的廠商，無需進行BGMP重新(xin)認證(zheng)或(huo)支付相(xiang)關費用
Step 5: Economic Information Reports and
Clinical Trial Requirements
步驟五：經濟信息報告和臨床試驗要求
ANVISA requires Economic Information Reports (EIRs) for some devices
in accordance with RDC 185/06. EIRS include:
ANVISA依據RDC 185/06對某些設備要求經(jing)濟信息報告（EIRs），
經濟信息報告包括：
Pricing comparisons for other 病人/使用者信息(xi)；
Patient/user information markets 其他市(shi)場定價的對比(bi)；
Marketing materials 營(ying)銷材料 ；
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：高風險和創新產品必須滿足ANVISA臨床試驗要
求。ANVISA通常承認產品在其他國家進行(xing)過的臨床試驗結果。
Step 6: Technical File Preparation
步驟6：技術文件準備
l Technical files ;required by ANVISA resemble documents
required by the US FDA
ANVISA所要求的技(ji)術文件與美(mei)國FDA所要求的相類似
l Technical files should be prepared according to RDC 185/01 Annex III Part A/B/C and provided in Portuguese
應根據RDC 185/01附件(jian)三(san)A/B/C部分(fen)要(yao)求(qiu)準備并提供葡(pu)萄牙文版(ban)的(de)技術文件(jian)
l Technical files should include information on device safety and effectiveness as well as product design data
技術(shu)文件(jian)須(xu)包(bao)括產(chan)品的安(an)全(quan)性和有效性以及產(chan)品的設計(ji)資料
l Meet ANVISA labeling requirements, labeling must be provided in Portuguese
滿足ANVISA標簽要求(qiu)，提(ti)供葡萄牙(ya)文(wen)版標簽
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.
若之前有準備過CE或美國FDA510（k）技術(shu)文(wen)件的(de)，通常可再用這些(xie)信(xin)息來準備巴西注(zhu)冊的(de)技術(shu)文(wen)件
Step 7: Submit Registration Application to
ANVISA
步驟7：向巴西國家衛生監督局提交注冊申請
l Your Brazilian Registration
Holder ;begins the process by
Submitting your registration
Application and Technical File
to ANVISA.
巴西注冊代表從向ANVISA
提交注冊申(shen)請和技(ji)術文件開始，
跟進注冊過程。
l Registration fees are due to ANVISA upon submission of your application and Technical File documents.
注冊費用由ANVISA根據所(suo)遞(di)交的注冊申請和技術(shu)文件收取。
l The device registration process is controlled by your BRH.
產品注冊過程由(you)巴(ba)西注冊代表進行跟進。
; ;
Step 8: ANVISA Review and Approval
步驟8：ANVISA審(shen)評和審(shen)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，II類(lei)和III類設(she)備的ANVISA注冊審(shen)評長達
6-12個月，IV類(lei)設備的時間將更長。
l ANVISA registrations are valid for five years.
ANVISA認證(zheng)有效期為五年(nian)。
Upon approval, ANVISA will publish your device’s registration number in the Diário Oficialda Uni?o 根據審批，ANVISA將在DiárioOficialda Uni?o公布產品注冊號(hao)
Ongoing Compliance Issues
持續法規遵守
l ANVISA conducts on-site
BGMP audits every two
Years
ANVISA每兩年(nian)進行(xing)一(yi)次
BGMP現(xian)場審核(he)
List of Brazilian regulatory documents:
巴西管理文件清單：
Thank you for your time!
List of all global offices:
全國服務熱線：
