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.
REGISTRATION & NOTIFICATION
| Document Title | Description | Issued by | Available Languages | Download |
|---|---|---|---|---|
| RDC No. 40/2015: Regulatory Requirements for Notification and Registration of Class I and Class II Medical Devices in Brazil. | Regulatory Requirements for Notification and Registration of Class I and Class II Medical Devices in Brazil. | Anvisa | English | For Sale |
| RDC No. 185/2001: Technical Regulation - The registration of Medical products at ANVISA: alteration, revalidation, or cancellation. (Annexes) | The Technical Regulation presented in the herein Annex about the registration of medical products at the Brazilian National Health Surveillance Agency (ANVISA), as well as its alteration, revalidation, and cancellation. Manufacturers or importers of a medical product shall submit to ANVISA the documents required for alteration, revalidation, and cancellation. | Anvisa | English | For Sale |
| RDC No. 67/2009: Technovigilance rules applicable to Registration Holders in Brazil. | This Resolution sets the general technovigilance requirements to be adopted by all registration holders for health products based in Brazil. Technovigilance is understood as a surveillance system for adverse events and technical complaints related to health products in post-marketing phase. | Anvisa | English | For Sale |
| Normative Instruction No. 32/2019: Inspection Processes and Requirements to verify the Good Manufacturing Practices of manufacturers of Active Pharmaceutical Ingredients, Health Products of risk class III and IV and Medicines. | This Normative Instruction establishes the procedures, flows, instruments and schedule related to compliance Inspection Processes and Requirements to verify the Good Manufacturing Practices of manufacturers of active pharmaceutical ingredients, health products of risk class III and IV and medicines. | Anvisa | English | For Sale |
| TECHNICAL NOTE No. 004/2016: Technical note about the need for submission of clinical trials for the purposes of registration of health equipment and materials. | Requirements to determine the need for clinical trials and guidelines for submission of data on safety and effectiveness for the purposes of registration of health products at the General Management of Technology of Health Products. | Anvisa | English | For Sale |
LABELING
| Document Title | Description | Issued by | Available Languages | Download |
|---|---|---|---|---|
| TECHNICAL NOTE No. 001/2013: Technical Note on Health Products Labeling Information. | Technical Note on Health products labeling Information. | Anvisa | English | For Sale |
| IN No. 04/2012: Rules for providing Instructions for Use of Healthcare Products in Non-printed formats. | This Normative Instruction hereby establishes the necessary requirements for providing, in non-printed formats, instructions for use of healthcare products subject to cadastro or registro registration and used by qualified professionals or in healthcare service environments. | Anvisa | English | For Sale |
GOOD MANUFACTURING PRACTICE (GMP)
| Document Title | Description | Issued by | Available Languages | Download |
|---|---|---|---|---|
| RDC No. 16/2013: Regulatory Requirements for Good Manufacturing Practices (GMP) for Medical Devices and In-Vitro Diagnostics in Brazil. | Regulatory Requirements for Good Manufacturing Practices (GMP) for Medical Devices and In-Vitro Diagnostics in Brazil. | Anvisa | English | For Sale |
| RDC No. 15/2014: Good Manufacturing Practice Certification for Medical Device Registration in Brazil. | Good Manufacturing Practice Certification for Medical Device Registration in Brazil. | Anvisa | English | For Sale |
| RDC No. 183/2017: Inspection programs and administrative procedures to grant of Good Manufacturing Practices Certificate to manufacturers of Medical Devices located outside the Brazilian territory and Mercosur. | Inspection programs and administrative procedures to grant of Good Manufacturing Practices Certificate to manufacturers of Medical Devices located outside the Brazilian territory and Mercosur. | Anvisa | English | For Sale |
| IN No. 8/2013: Good Manufacturing Practices of Medical Devices and In-Vitro diagnostic products for importers, distributors, and storage companies. | This Normative Instruction hereby establishes the requirements of the technical regulation of Good Manufacturing Practices of medical devices and in-vitro diagnostic products applicable to importers, distributors and storage companies. | Anvisa | English | For Sale |
CERTIFICATION & COMPLIANCE
| Document Title | Description | Issued by | Available Languages | Download |
|---|---|---|---|---|
| RDC No. 56/2001: Technical Regulation: Essential Requirements for Safety and Efficacy of Medical devices. | Technical Regulation: Essential Requirements for Safety and Efficacy of Medical devices. | Anvisa | English | For Sale |
| ORDINANCE No. 118/2015: General Requirements for Product Certification (RGCP). | General Requirements for Product Certification (RGCP). | Inmetro | English | For Sale |
| ORDINANCE No. 54/2016: Compliance Assessment Requirements for Equipment under Regime of Health Surveillance. | Compliance Assessment Requirements for Equipment under Regime of Health Surveillance. | Inmetro | English | For Sale |
IMPORTATION
| Document Title | Description | Issued by | Available Languages | Download |
|---|---|---|---|---|
| RDC No. 25/2001: Provisions on the import, commercialization and donation of used and refurbished healthcare products. | Provisions on the import, commercialization and donation of used and refurbished healthcare products. | Anvisa | English | For Sale |
RISK CLASSIFICATION
| Document Title | Description | Issued by | Available Languages | Download |
|---|---|---|---|---|
| RDC No. 36/2015: Resolution on the Risk Classification, the systems of Notification Control, Registration and Labeling requirements and instructions for use for In Vitro Diagnostic Devices and their instruments. | This Resolution establishes the risk classification, notification control regimes, registration and labeling requirements and instructions for use of in vitro diagnostic products, including their instruments. (Redaction by Resolution - RDC No. 270, of February 28th, 2019). | Anvisa | English | For Sale |
| IN No. 3/2015: Normative Instruction describes the classification of risk of cadastro and registro registrations for In Vitro Diagnostic products. | Normative Instruction describes the classification of risk of cadastro and registro registrations for in vitro diagnostic products. | Anvisa | English | For Sale |
GRP WHITEPAPER: HOMOLOGATION OF MEDICAL DEVICES & COMPONENTS IN BRAZIL BY ANATEL
Medical Devices that use functionalities such as Bluetooth, Wi-Fi and other wireless connectivity features require ANATEL registration is required as part of the registration process of devices as per the new Brazilian medical device regulations. ANATEL certification as a component of registration and modification applications for devices used for telecommunication as well as for devices using radio frequency (RF) or wireless technology.