A guide for importing medical equipment into brazil 1. The document protocol shall comply with the provisions in rdc no. Rdc 16 rdc 59 and portaria 686 future revision of anvisa rdc 59 brazilian gmp. Ausraa australias regulatory process for medical devices. The place of ceps in anvisa, brazil jeanne sophie gautier anvisa the place of the certification procedure in the global re gulatory environment 1920 september 2017 prague, czech republic. Requirements for labelling of nivds are established on rdc 185 2001 and of ivds on rdc 362015 all labelling must be in portuguese for imported devices it is allowed the importation without labels in portuguese. Active pharmaceutical ingredients questions and answers. These files are maintained by your brh in case of anvisa onsite inspections. The primary challenge to successfully submitting an anvisa regulatory file is directly associated with bio.
Brazil anvisa regulatory approval process for medical devices. Anvisa premarket approval rdc 185 2001 anvisa good manufacturing practices rdc 1620 anvisa gmp certification requirement for product registration rdc 252009 anvisa pms rdc 672009 and rdc 232011 food and drugs act r. Companies need to understand the regulatory structure as well as their requirements to initiate product development in a new country. Classification rules are contained in annex ii of rdc 185 2001. Rdc resolution of board of directors, anvisa sbac brazilian compliance evaluation system sdci secretariat of development and industrial competitiveness, mdic secex secretariat of foreign trade, mdic sgt working subgroup, gmc, mercosul sgef secretary of economic policy sps sanitary and phytonanitary tbt technical barriers to trade. According to anvisa, all medical devices are regulated by the brazilian ministry. For the past five years, anvisa has updated their regulations and developed numerous guidances. Brazil medical device regulations anvisa guidelines emergo. Promoting medical products globally baker mckenzie. Class iii and iv device manufacturers must prepare a technical file including clinical data, clinical studies, and additional device information in accordance with annex iii part a, b or c of rdc 185 01 and submit to anvisa. The collegiate board of directors of the brazilian national health surveillance agencyin the, exercise of the powers article 11, vested by subsection iv, from the regulation approved by decree no. All documents listed below were published by anvisa in portuguese and. Medical device registration process in brazil anvisa.
The monitoring authority in brazil known as anvisa is known for its work and functions with their set of requirements for gmp inspections. Send legal documents, as well as proposed rdc 185 2001compliant labeling ifu and labels to brh. All files at this point must be submitted in brazilian portuguese. The board of the national health surveillance agency, in exercise of the powers conferred on it by sections iii and iv of art. A guide for importing medical equipment into brazil. New regulation for stability studies of medicinal products. Medical device registration process in brazil anvisa marceloall, is there an rdc that aligns with section 8. Anvisa primarily aims at protecting and promoting public health, exercising health surveillance of products and services that include processes, ingredients and technologies that may pose any health risks. Content of the dossier for chemical purity and microbiological quality in effect until december 2018 guideline on requirements for revisionrenewal of certificates of suitability to the european pharmacopeia monographs in effect until december 2018. The collegiate board of director of the brazilian national health surveillance agency anvisa. Download the chart in pdf, or read below for the explanation of the process. If approved, anvisa will publish registration number in the dirio oficial da unio dou. Anvisa will use this audit to investigate the product and its safety. We also can help you register your medical devices with anvisa.
The requirements for api mas are listed on rdc 572009. Ministry of health mh national health surveillance. Brazil medical device registration and approval chart emergo. This will include clinical data and studies, device information, and parts of the rdc 185 2001. Yes, please send the documentation in a searchable and indexed pdf file. Brazilian resolution rdc 185 01 is similar to the european medical devices directive 9342eec and classification is very similar. Overview brazil is one of the biggest countries in south america and latin america.
Resolution rdc number 185, from 10222001 approve the technical. National health surveillance agency anvisa this text is not a substitute for that published in the federal official gazette of brazil unofficial translation. Anvisa gmp certification requirement for product registration rdc 252009. Brazil medical device regulations anvisa guidelines. Some devices will be required to be economic information report eir compliant according to. Regulatory impact analysis initiated plan to use imdrf documents as.
Anvisa medical device registration and approval in. Class i class ii class iii class iv appoint a company that holds a company working allowance permit from anvisa as your brazil registration holder brh. This includes information about the devices in accordance with annex iii part abc in rdc 185 2001, as well as proposed labeling and instructions for use for the devices. Pay the application fee and have the brh will submit the application to anvisa. Our guide for how to register medical devices in brazil. Medicinal product regulation and product liability in brazil. Registration renewals must be initiated one year, and no later than six months, prior to expiration. Mapping of applicable technical regulations, conformity assessment. Defines the registration requirements of medical products. It spends hugely on healthcare boosting the medical devices locally. Class iii and iv registrations are valid for 5 years. Article 5 the manufacturing site undergoing the certification process may send the documents referred to in items viii to xii of article 4 directly to anvisa, as long as the.
General overview of the brazilian regulatory framework 3. The brazilian anvisa medical device approval process explained. Mapping of applicable technical regulations, conformity. Anvisa accepts dmfs in portuguese, english and spanish. Legal documents, ifus, and proposed labeling are also included in the technical file.
Guide for regularization of medical equipment in anvisa. Anvisa encourages applicants and api manufacturers to. On november 7, 2019, anvisa published the resolution rdc 3182019, which defines the criteria for conducting stability studies of medicinal products and active pharmaceutical ingredients apis, except for biologicals, for the evaluation of results, and for the preparation of protocols and stability reports. A guide to brazils medical device requirements nist. Medicinal product regulation and product liability in.