Brazil's Medical Device Regulations

Medical devices are governed by ANVISA, the Agência Nacional de Vigilância Sanitária, under the Brazilian Ministry of Health. ANVISA is an autonomous arm of the government and is responsible for the protection of the public’s health. Anvisa categorizes Medical Devices into four types: medical equipment, materials for health use, orthopedic implants and in vitro diagnostics.

Table of Contents

REGISTRATION & NOTIFICATION
Document Number Document Title Issued by Description Available Languages Download
RDC No. 185/2001 RESOLUTION OF THE COLLEGIATE BOARD - RDC No. 185, OF OCTOBER 22nd, 2001 Anvisa Approves the Technical Regulation presented in the herein Annex about the registration of medical products at ANVISA, as well as its alteration, revalidation, or cancellation. English/Portuguese For Sale
RDC No. 23/2012 RESOLUTION OF THE COLLEGIATE BOARD - RDC No. 23, OF APRIL 4th, 2012 Anvisa It addresses the compulsory execution and notification of field actions by the registration holders for health products in Brazil. English/Portuguese For Sale
RDC No. 40/2015 RESOLUTION OF THE COLLEGIATE BOARD - RDC No. 40, OF AUGUST 26th, 2015 Anvisa Defines the requirements for notification and registration of medical products. English/Portuguese For Sale
RDC No. 67/2009 RESOLUTION OF THE COLLEGIATE BOARD - RDC No. 67, OF DECEMBER 21st, 2009 Anvisa It addresses technovigilance rules applicable to registration holders for health products in Brazil. English/Portuguese For Sale
ORDINANCE No. 118/2015 ORDINANCE No. 118, OF MARCH 6th, 2015 Anvisa General Requirements for Product Certification (Requisitos Gerais de Certificação de Produtos - RGCP). English/Portuguese For Sale
RISK CLASSIFICATION
Document Number Document Title Issued by Description Available Languages Download
RDC No. 36/2015 RESOLUTION OF THE COLLEGIATE BOARD - RDC No. 36, OF AUGUST 26th, 2015 Anvisa It provides on the risk classification, the systems of notification control, registration and labeling requirements and instructions for use of products for in vitro diagnosis, including their instruments and makes other provisions. English/Portuguese For Sale
IN No. 3/2015 NORMATIVE INSTRUCTION - IN No. 3, OF AUGUST 26th, 2015 Anvisa It regulates item I of Art. 20 of the Resolution of the Collegiate Board – RDC no. 36, of August 26th, 2015, that describes the classification of risk, the schemes for control of cadastro and registro registrations and the requirements for both labeling and instructions of use for in vitro diagnostic products, including its instruments, and gives other provisions. English/Portuguese For Sale
LABELING
Document Number Document Title Issued by Description<