Brazilian Drug and Medical Device Regulation - Food and Drug Law ...

Brazilian Drug andMedical DeviceRegulation:A Practical GuideEdited byCarlos T. Angulo and Areta L. Kupchyk

IntroductionThe Food and Drug Law Institute (FDLI) is pleased to provide Brazilian Drug and Medical Device Regulation: APractical Guide as a companion product to our pioneering conference, U.S. & Brazil: Navigating New Frontiers inPharmaceutical, Medical Device, and Food Law and Regulation. With this practical book and the groundbreaking2012 Brazil conference, FDLI is continuing its role as a leading provider of publications and programming in thearea of global food and drug law.Brazil is a fast-growing economy and of great interest to U.S. and international drug, medical device andfood companies. Brazil is currently the eighth largest goods trading partner with $75 billion in total (twoway)goods trades during 2011. Exports were valued at $65 billion while imports were valued at $39 billion.U.S. goods and services trade with Brazil was estimated at $103 billion in 2011. In March 2011, Brazil andthe U.S. signed an agreement on trade and economic cooperation and established the United States-BrazilCommission on Economic and Trade Relations, with the objective of promoting bilateral economic and tradecooperation, including intellectual property rights and regulatory issues affecting trade and investment.The U.S. Food and Drug Administration has opened offices outside of the United States and specifically in LatinAmerica, where it is collaborating with its counterpart, the Brazilian Health Surveillance Agency (ANVISA). U.S.drug and medical device companies wanting to do business in Brazil need to understand ANVISA proceduresin administering the regulatory scheme for drugs and medical devices, as well as FDA requirements. ThisPractical Guide, written by experienced Brazilian lawyers and regulatory specialists, provides summaries ofBrazil’s requirements for the development, approval and marketing of drugs and medical devices. This Guidealso includes English translations of many relevant laws and directives. This Guide is intended to help you totake advantage of various marketing pathways and enable successful partnerships in Brazil.viii

Chapter 1. Overview of Regulatory Framework and Governmental Oversightin BrazilBy Marcelo França Brisolla, Angela Fan Chi Kung, Camila Martino Parise and Benny SpiewakLegal SystemBrazil is a Federative Republic in which broad powers are granted to the federal government. The Constitutioncurrently in force, promulgated on October 5, 1988, establishes a presidential system with three separatebranches: executive, legislative and judicial.The legislative arm of the government is the Brazilian Congress (the Senate and the House of Representatives),whose members are elected on a proportional representation basis weighted in favor of the less populatedstates.The judicial branch comprises the Federal Supreme Court, the Superior Court of Justice and various lowerfederal and state courts.Brazil is a civil law country, adopting a codified legal system with a hierarchy of laws that encompasses theConstitution and amendments to the Constitution, supplementary, ordinary and delegated laws, provisionalmeasures, decrees, and ordinances or resolutions.Laws, delegated laws, provisional measures and decrees are enacted by the Brazilian legislative branch.Ordinances and resolutions are enacted by the administrative authorities. Under the hierarchy of laws, anordinance or resolution cannot create rules or limitations not established in a law or a decree, as its purposeis restricted to supplementing and regulating them. However, regulation by administrative authorities oftenextends beyond the limits prescribed by law.The Constitution establishes the universal healthcare system, under which the state has the duty to provide allcitizens with access to healthcare, and creates the Unified System of Health (known as SUS).Brazil is the only country in the world with a population of more than 100 million inhabitants 1 that has auniversal healthcare system. This scenario gives rise to considerable pressure on the government to adoptpublic health policies aimed at guaranteeing access to health at the lowest cost possible. As a result, thegovernment, as the main payer for drugs and healthcare services, often intervenes in the market by controllingprices and imposing mandatory discounts.Supervision and AdministrationDrugsThe Brazilian Federal Constitution has entrusted the provision of public healthcare to the Ministry of Health(MOH).In 1999, the National Agency of Sanitary Surveillance (ANVISA) was created 2 as an independent agencyoperating under a special regime and reporting to MOH. ANVISA was given the duties of sanitary surveillance,including powers to regulate and supervise the registration, manufacture, distribution and dispensing of drugsand, thus, to ensure the health and safety of consumers. ANVISA is ruled by a Collegiate Board of Directorscomposed of five members.

BRAZILIAN DRUG AND MEDICAL DEVICE REGULATION: A PRACTICAL GUIDEThe “health authority” concept encompasses a number of governmental authorities devoted to theprotection of health, from ANVISA down to its several departments and including State and Municipal HealthDepartments. Supervision of product quality and safety, as well as of means of production, is simultaneouslyentrusted to the three government levels (federal, state and municipal). Regulations, in turn, apply to the entirecountry when issued by ANVISA. Although the same authority is granted to other government levels, thescope of these regulations is obviously limited to their respective jurisdictions. The pharmaceutical industry isregulated by MOH and ANVISA at their various departments and levels.Each state is competent to establish the requirements that it deems necessary for effective sanitarycompliance, subject to federal legislation.Product registration, clearance of drugs at the ports and airports, certification of Good Manufacturing Practices(GMP) and compliance with advertising rules on drugs are dealt with at the federal level by ANVISA.Surveillance and inspection of pharmaceutical companies are dealt with at the state or municipal levels.Medical DevicesANVISA is responsible for the supervision and administration of medical products, including medical devices.ANVISA governs the import, distribution and marketing of medical devices. Product registration, premarketsubmission and approval are required. 3 A foreign company must work through a local Brazilian entity to obtain amarketing license from ANVISA to import and distribute medical devices in Brazil.There are two regulatory pathways for medical devices: 1) notification (“cadastro”) for Class I and II devices thatare considered low risk and, therefore, subject to basic controls; and 2) registration (“registro”) for Class III and IVdevices, which are considered higher risk, and Class I and II devices that are deemed higher risk and, therefore,are subject to greater controls. 4Available Sources of Laws and Regulations: A Quick ReferenceDrugsThe Brazilian Presidency and Senate websites (www.planalto.gov.br and www.senado.gov.br, respectively)contain an updated version of the Constitution and its amendments, supplementary, ordinary and delegatedlaws, provisional measures and decrees.Sanitary ordinances and regulations can be found at ANVISA’s website (www.anvisa.com.br) and the Ministry ofHealth’s website (www.saude.gov.br). However, such websites do not always provide current versions of suchlegal documents.Therefore, the most reliable sources for updated sanitary regulations are law firms or other private sources ofinformation, although these private entities charge their users a certain access fee and their databases are all inPortuguese.Medical DevicesThe following are regulations relevant to medical devices:(1) ANVISA Resolution RDC No. 3 of 2 February 2010 – How registration submissions are prioritized2

OVERVIEW OF REGULATORY FRAMEWORK AND GOVERNMENTAL OVERSIGHT IN BRAZIL(2) ANVISA Resolution RDC No. 16 of 23 April 2009 – GMP certification and maintenance(3) ANVISA Resolution RDC No. 24 of 21 May 2009 – Registration application process(4) ANVISA Resolution RDC No. 25 of 21 May 2009 – Establishes onsite GMP inspection requirementbased on device risk(5) ANVISA Resolution RDC No. 27 of 21 June 2011 – INMETRO certification procedures(6) ANVISA Resolution RDC No. 39 of 5 June 2008 – Regulations pertaining to clinical research(7) ANVISA Resolution RDC No. 55 of 4 November 2011 – Requirements for surgical and examinationgloves(8) ANVISA Resolution RDC No. 59 of 27 June 2000 – Good Manufacturing Practices for medical devices(9) ANVISA Resolution RDC No. 67 of 21 December 2009 – Vigilance requirements(10) ANVISA Resolution RDC No. 81 of 5 November 2008 – Technical regulations for imported goods(11) ANVISA Resolution RDC No. 97 of 9 November 2000 – Product family definition(12) ANVISA Resolution RDC No. 167 of 2 July 2004 – Guidelines for inspection of IVD manufacturers(13) ANVISA Resolution RDC No. 185 of 13 October 2006 – Economic Information Report requirements(14) ANVISA Resolution RDC No. 185 of 22 October 2001 – Medical device classification rules, technicalfile requirements(15) ANVISA Resolution RDC No. 61 of 18 November 2011 – IVD classification and requirements(16) ANVISA Resolution RDC No. 3385 of 13 October 2006 – List of products which require an EconomicInformation Report(17) Ordinance 686 of 27 August 1998 – Brazil Good Manufacturing Practices for in vitro diagnosticsEndnotes1. http://portalsaude.saude.gov.br.2. Law No. 9782/99.3. Law No. 6360 of 1976, Decree 74.094/97, ANVISA Resolution RDC No. 85/2001.4. ANVISA Normative Ruling No. 2/2011.3