Medical Device Approvals inBrazil: A Review and Update
Medical Device Approvals in Brazil: A Review and UpdateMedical Device Approvals in Brazil:A Review and UpdateWith a popula...
Medical Device Approvals in Brazil: A Review and UpdateBrazil is a member of the Southern             companies based else...
Medical Device Approvals in Brazil: A Review and UpdateGMP Inspection                                   responsible for ac...
Medical Device Approvals in Brazil: A Review and UpdateSteps to INMETRO CertificationOnce a medical device has been tested...
Medical Device Approvals in Brazil: A Review and Update2: Pre-License Inspection                         8.2.4: Monitoring...
Medical Device Approvals in Brazil: A Review and UpdateAnnual InspectionLike most other product certificationsystems, main...
Medical Device Approvals in Brazil: A Review and UpdateConclusionThe current size and anticipated continued growth of the ...
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Ul wp final_medical device approvals in brazil_v6

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This UL white paper reviews Brazil’s current regulatory framework for medical
devices, and the requirements for those entities seeking to manufacture, import or
sell medical devices in the country. It also discusses the registration and certification
process required of all device manufacturers, importers and distributors, and the
steps necessary to secure and maintain approval for medical devices. This white
paper includes information on requirements found in RDC 27/IN-3 and Resolution 350,
published by Brazilian regulatory authorities in June 2011.

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Ul wp final_medical device approvals in brazil_v6

  1. 1. Medical Device Approvals inBrazil: A Review and Update
  2. 2. Medical Device Approvals in Brazil: A Review and UpdateMedical Device Approvals in Brazil:A Review and UpdateWith a population of more than 190 million people and a mature healthcare system,Brazil represents the largest medical equipment market in South America and one ofthe largest markets in the world1. Manufacturers seeking to expand their market reachby selling medical devices in Brazil will encounter an evolving regulatory approvalssystem, including mandatory device registration. Because the Brazilian marketrepresents such a significant opportunity, manufacturers of medical devices canbenefit from understanding both the regulatory requirements and the registrationand certification process for their products.This UL white paper reviews Brazil’s current regulatory framework for medicaldevices, and the requirements for those entities seeking to manufacture, import orsell medical devices in the country. It also discusses the registration and certificationprocess required of all device manufacturers, importers and distributors, and thesteps necessary to secure and maintain approval for medical devices. This whitepaper includes information on requirements found in RDC 27/IN-3 and Resolution 350,published by Brazilian regulatory authorities in June 2011.Regulatory BackgroundResolution RDC No. 185 of October 22, 20012 is the primary regulation applicable to theregistration of all medical devices, except for in vitro diagnostic (IVD) devices, whichare covered by Resolution RDC No. 206 of November 2006. RDC No. 185 describes theapplicable device registration protocol and lists the documents required to legallyregister a medical device in Brazil. Annex II of RDC No. 185 describes the classificationstructure applicable to medical devices, assigning medical devices to one of fourdistinct risk classes (I, II, III and IV) according to 18 different rules. The classificationstructure for medical devices in Brazil corresponds to that used in the European Union(EU) under Council Directive 93/42/EEC concerning medical devices.page 2
  3. 3. Medical Device Approvals in Brazil: A Review and UpdateBrazil is a member of the Southern companies based elsewhere that do not 2. Certificate of Good ManufacturingCommon Market, also known as have subsidiaries in Brazil must depend Practice (GMP)MERCOSUR, which includes the countries on Brazilian-based third parties, such 3. Instructions manual in Portugueseof Argentina, Paraguay and Uruguay. As as hosting companies, distributors and 4. Labeling and packagingsuch, the process for the registration of dealers, to obtain ANVISA registrationmedical devices in Brazil has been partially for medical devices. Under such an 5. Letter from the deviceharmonized with that of these countries, arrangement, the local third party manufacturer, authorizing atheoretically easing the process of gaining holds the ANVISA registration, and a Brazilian company to hold theadmission to these other markets. manufacturer must maintain an effective product registration and distribute a device commercial relationship with a third partyANVISA Registration Process to ensure the ongoing maintenance of a 6. Clinical trials (sometimes it canAll medical devices imported into or registration. Otherwise, a manufacturer be replaced by the INMETROdistributed within Brazil must first be will need to repeat the registration certification or literature provingregistered with the Agência Nacional process with another local third party to the effectiveness of the device)de Vigilância Sanitária, also known maintain market access. 7. List of all device accessoriesas ANVISA or the National Health The registration of most Class 1 and 2 8. For some devices, such asSurveillance Agency. Established in devices involves a relatively simple implantable medical devices,19993 under Brazil’s Ministry of Health, application process – referred to as cardiovascular products, high-riskANVISA is an independently administered, “cadastro,” meaning “abbreviated IVDs, dialysis equipment andfinancially autonomous regulatory registration” – based on the low to personal hearing aid systems, anagency responsible for the regulation moderate risk associated with devices Economic Information Reportand oversight of medical devicesand other medical products in Brazil. in these classes. However, based on the 9. INMETRO certificate,Specifically, ANVISA is responsible for the greater degree of risk associated with when applicableregistration of medical devices and for their use, a more rigorous process applies to some Class 1 and Class 2 medical The complete set of documentationthe maintenance of a registered products devices, as well as all Class 3 and Class 4 depends on the nature of the device, e.g.,database4. Unlike the EU Notified devices. In these cases, the party applying IVD devices, implants, electro-medicalBody system, the 510(k) system of the devices, etc. Defining the exact packageFood and Drug Administration (FDA) for ANVISA registration may be required of documentation is a complex process,in the United States, or the Canadian to provide some or all of the following and requires consulting various lawsMedical Device Conformity Assessment documentation with an application, and decrees (Law 6360:1976, RDC No.System (CMDCAS), ANVISA performs all depending on the device characteristics 185:2001 and RDC No. 59:2000). Theregistration and inspection functions and classification: documentation list above applies to thewithin the agency. 1. Free sales certificate (it can majority of medical devices; in practice,Only companies based in Brazil can be replaced by the INMETRO however, required documentation can beapply for ANVISA registration. Therefore, certificate when applicable) much more extensive.page 3
  4. 4. Medical Device Approvals in Brazil: A Review and UpdateGMP Inspection responsible for accrediting certification • NBR ISO 7785-1:1999:and Certification organizations that certify products for Dental handpieces – Part 1: compliance with applicable requirements High-speed air turbine handpiecesGMP certification based on an inspection and authorize the use of approvedconducted by ANVISA is required for • NBR ISO 7785-2:2004: certification marks. This certificationregistration (RDC No. 25, May 21, 2009). Dental handpieces – scheme is known as the BrazilianThe GMP certificate must be submitted Part 2: Straight and geared Conformity Assessment System (SBAC).with the registration application for all angle handpieces UL has been accredited by INMETROClass III and IV devices, as well as for Class to evaluate and test products, devices, • NBR ISO 9680:2001:I and II devices noted on the Exemption equipment, material, processes and Dentistry - Operating lightsList (Instruction IN-2, June 6, 2011). GMP services for compliance with the • NBR ISO 9919:1997: Medicalinspections are also required to revalidate standards recognized by SBAC. electrical equipment – Particularor update existing registrations. TheGMP certificate is valid for two years, To qualify for INMETRO certification, requirements for the basic safetyand ANVISA alone determines whether medical device manufacturers must have and essential performance ofsubsequent evaluations can be completed their products tested to SBAC-recognized pulse oximeter equipment forremotely through a paperwork audit. The standards by an INMETRO-accredited medical useapplication for GMP should contain the testing laboratory. The Associação • NBR ISO 11195:2000: Gas mixersfollowing documentation: Brasileira de Normas Técnicas, also for medical use – Stand-alone known as ABNT or the Brazilian gas mixers • Device description and indication Association for Technical Standards, of risk class • NBR ISO 8835-2:2010: Inhalational is responsible for the approval of all • Complete flow chart describing anaesthesia systems – Part 2: standards and for the application of any the relationship with third-party Anaesthetic breathing systems national deviations, typically limited to manufacturers, if any translation of a standard into Portuguese. • NBR IEC 61689:1998: Ultrasonics • Payment receipt for the GMP ABNT approved standards are generally – Physiotherapy systems – Field inspection fee preceded by an NBR designation. specifications and methods of measurement in the frequency • The GMP inspection check for Consistent with the requirements of range 0.5 MHz to 5 MHz compliance with RDC No. 59 RDC No. 27 and IN-3 published in June 2011, all medical devices sold in Brazil Importantly, under RDC No. 27 andINMETRO Certification Process that fall under the scope of the following Instruction IN-3, the third edition of IECBrazil’s Instituto Nacional de Metrologia, standards must be INMETRO certified: 60601-1 is now acceptable in Brazil forNormalização e Qualidade Industrial, INMETRO certification. This is a significant • NBR IEC 60601 seriesalso known as INMETRO or the National change from RCD No. 32 that omittedInstitute of Metrology, Standardization • NBR ISO 6875:1998: the third edition of IEC 60601-1 from theand Industrial Quality, is the body Dental patient chair Brazilian certification scheme.page 4
  5. 5. Medical Device Approvals in Brazil: A Review and UpdateSteps to INMETRO CertificationOnce a medical device has been tested to the requirements of the appropriate technicalstandard and all user manuals have been translated into Portuguese, an applicant canproceed with the INMETRO certification process. The INMETRO-accredited certificationbody will then conduct the steps described in the following sections.1: Documentation AnalysisFirst, the certification body will review the product documentation, consisting ofthe following: • User manuals translated into Portuguese • Quality manual and master control list of a manufacturer’s quality management system • Some certification agencies will accept a manufacturer’s test reports, such as IECEE CB Scheme test reports, that have been issued within the past two years. Other test that are acceptable to a wider range of certification agencies include reports issued by organizations accredited by signatories of the International Laboratory Accreditation Cooperation (ILAC), including the American Association for Laboratory Accreditation (A2LA) and the U.S. National Voluntary Laboratory Accreditation Program (NVLAP). • If a device remains unchanged since the test reports were originally issued, a manufacturer should provide a declaration to that effectThe certification body will review the test reports to assess whether a medical devicehas been completely evaluated to all applicable standards, including collateral andparticular standards, and complete any additional tests that might be required.During this analysis, the certification body may also create a file that containstechnical information about a device, including a list of critical components. When thecertification body is satisfied that a product complies with applicable requirements,a pre-license inspection is performed.page 5
  6. 6. Medical Device Approvals in Brazil: A Review and Update2: Pre-License Inspection 8.2.4: Monitoring and measurement manufacturer are compliant with all of product applicable requirements, the certificationThis factory inspection is similar to body issues an INMETRO certificate.CENELEC’s Common Interest Group 8.3: Control of nonconforming product An INMETRO certificate is valid for five(CIG) 23 quality inspection. The scope 8.5.2: Corrective action years, and evidence of the certificationof the pre-license inspection includes In addition to the ISO clauses above, is published in INMETRO’s directory ofverification of compliance with the an auditor conducting a pre-license approved products. In addition, evidencefollowing clauses of ISO 13485:2003: inspection will look for evidence that of certification may also be published by4.2.3: Control of documents the following production tests are being the certification body in its own directory4.2.4: Control of records performed by a manufacturer on 100% of approved products. of those medical devices bearing the At the end of a certification process,7.1: Planning of product realization INMETRO mark: an applicant is authorized to use7.2.3: Customer communication • Leakage current certification marks to demonstrate a7.3.6: Design and development validation (earth, enclosure, patient) device’s compliance (examples of marks7.3.7: Control of design and (Clause 19 of IEC 60601-1) issued by UL are shown in Figure 1). These marks should be placed on bothdevelopment changes • Earthing the approved medical device and on the7.4.3: Verification of purchased product (protective/functional and product packaging. The orange-colored, potential equalization)7.5.1: Control of production and rectangular mark should be a minimum (Clause 18 of IEC 60601-1)service provision of 50 mm in size. The black and white • Dielectric strength marks with the wording INMETRO and7.5.2: Validation of processes for (Clause 20 of IEC 60601-1) OCP-0029 should be at least 22 mm. Theproduction and service provision • Functional test smallest mark with the word SEGURANÇA7.5.3: Identification and traceability should be at least 11 mm. These two 3: Certification and Product Marking7.5.5: Preservation of product smaller marks are used only in cases After a certification body has where there is insufficient space for the7.6: Control of monitoring and completed its review of test reports largest rectangular mark. The certificationmeasuring devices and user manuals as well as its body should provide instructions for8.2.3: Monitoring and measurement pre-license factory inspection and has appropriate use of the certification marksof processes determined that a device and the device as well as artwork for printing purposes.      Figure 1: INMETRO Certification Markspage 6
  7. 7. Medical Device Approvals in Brazil: A Review and UpdateAnnual InspectionLike most other product certificationsystems, maintaining an INMETROcertification requires certain periodicactivities. For an approved medicaldevice to remain INMETRO certified forthe full five year certification period,a manufacturer’s facility is subject toannual surveillance inspections. Anannual INMETRO inspection should takeplace approximately 12 months after theoriginal certification has been issued andat succeeding 12 month intervals for theduration of the certification period. Forexample, for a certification originallyissued in November 2010, the firstannual surveillance inspection would beconducted around November 2011, andagain in November 2012, November 2013and November 2014.When a certification body has locallyqualified staff and facilities, the annualINMETRO surveillance inspections can beconducted by local assessors. The scope to issue CB Test Reports or that is ILAC Companies that do not comply withof these annual maintenance inspections accredited. A device needs to be retested the approval requirements for medicalis the same as the pre-license inspection even if its design is unchanged since the devices can face severe penalties, fromconducted at the beginning of the financial assessments to the confiscation initial product approval.certification process. of unapproved products. CustomsRecertification Other Issues and Concerns officials in Brazil will only authorize the importation of products after consultingAs previously mentioned, the INMETRO Most safety certifications provide with ANVISA’s approved productscertificate is valid for a period of five testing to a base standard and applicable database to ensure that a product hasyears, after which a device must be particular standards. ANVISA requires been properly registered. In case ofrecertified. If a certificate holder wishes products to be tested to most of the doubt, customs officials will typicallyto renew a medical device certification for particular and collateral standards, hold all products at an owner’s expenseadditional five year term, a device needs including IEC 60601-1-2 (EMC) and IEC until registration and certification canto be fully retested by any laboratory able 60601-1-4 (software). be verified.page 7
  8. 8. Medical Device Approvals in Brazil: A Review and UpdateConclusionThe current size and anticipated continued growth of the Brazilian market presentssignificant opportunities for manufacturers of medical devices. Brazil’s regulatoryapproval scheme for medical devices is similar to that found in other countries. Inaddition, Brazil relies on national versions of widely accepted international standardsto assess product compliance.Despite these similarities, the length of time between filing an application for aregistration of a medical device and the final government approval can be lengthy.The International Trade Administration of the U.S. Department of Commerce estimatesthat it can take as little as three months or as long as two years to achieve productregistration, depending on the type of submission to ANVISA, i.e., new registration,update or revalidation.5Medical device manufacturers can ease the process of gaining access to this lucrativemarket by understanding the similarities and differences between Brazil’s medicaldevice approval scheme and the schemes used in other major markets. Stayinginformed of anticipated changes in regulations can provide valuable time to developalternative plans and strategies for gaining and maintaining market access. Finally,working with an experienced and knowledgeable accredited certification body inBrazil such as UL can smooth the compliance process and mitigate setbacks fromunanticipated issues and challenges.For more information about the “Approval of Medical Devices in Brazil” white paper,please contact Tara Kambeitz, global marketing manager – Health Sciences atTara.L.Kambeitz@us.ul.com.1 U.S. Department of Commerce, International Trade Administration, “Healthcare Technologies Resource Guide – A Reference for US Exporters to World Markets,” 2009-2010 edition.2 Brazil Resolution RDC No. 185, October 22, 2001, http://www.anvisa.gov.br/legis/resol/2001/185_01rdc.htm (last accessed on June 10, 2011).3 www.anvisa.gov.br/eng/legis/law_9782.htm4 A full description of ANVISA’s structure and responsibilities is available at http://www.anvisa.gov.br/eng/institution/index.htm (last accessed on June 11, 2011).5 “Medical Device Regulatory Requirements for Brazil, International Trade Administration,” U.S. Department of Commerce, updated March 2011, http://www.ita.doc.gov/td/health/brazilmdprofile.pdf (last accessed on June 10, 2011).UL and the UL logo are trademarks of Underwriters Laboratories Inc. © 2011.Copyright©2011 Underwriters Laboratories Inc. All rights reserved. No part of this document may be copied or distributed without theprior written consent of Underwriters Laboratories Inc. 7/11THIS DOCUMENT IS PROVIDED FOR INFORMATIONAL PURPOSES ONLY AND IS NOT INTENDED TO CONVEY ANY LEGAL ADVICE.USE OF THE INFORMATION IN THIS DOCUMENT IS AT YOUR OWN RISK. PLEASE CONSULT WITH LEGAL COUNSEL FOR ADVICE ONCOMPLYING WITH THE REGULATIONS DESCRIBED ABOVE.page 8

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