Chapter 1 Brazilian ANVISA Administration Information Abstract

1. Administration and Abstract

The Brazilian Health Regulatory Agency (Anvisa) is an autarchy linked to the Ministry of Health, part of the Brazilian National Health System (SUS) as the coordinator of the Brazilian Health Regulatory System (SNVS), present throughout the national territory.

Anvisa’s role it to promote the protection of the population’s health by executing sanitary control of the production, marketing and use of products and services subject to health regulation, including related environments, processes, ingredients and technologies, as well as the control in ports, airports and borders.

2. Administrative Regulation

• Medical Equipments: Resolution RDC 185/2001 and RDC 40/2015

• Materials for health use: Resolution RDC 185/2001 and RDC 40/2015

• Orthopedic Implants: Resolution RDC 185/2001

• In vitro diagnostics: Resolution RDC 36/2015

• Clinical Trials:The regulation that normalizes the submission of clinical trials with Medical Devices to ANVISA’s approval is the Resolution RDC 10/2015

3. Risk Level Classification of Medical Device and IVD Products

Anvisa classifies medical devices into four categories: medical devices, hygiene materials, orthopaedic implants, and in vitro diagnostics.

Medical devices in Brazil are divided into four categories based on the risk posed to the human body.

The latest Brazilian regulation is RDC 751/2022, which came into effect on March 1, 2023, and the new regulation is closer to the European Union, including the definition of medical devices, classification rules. Medical devices also follow 22 classification rules, which are largely similar to the 22 rules outlined in the European Medical Device Directive (MDD) 93/42/EEC.

4. Entry Requirements

Foreign medical device manufacturers without a physical location in Brazil must designate a Brazilian Registration Holder (BRH). BRH acts as the liaison between the manufacturer company and the Brazilian Health Regulatory Agency (ANVISA) and is responsible for the manufacturer's registration of medical devices in Brazil and is noted on the device registration.

Manufacturers are required to maintain BRH as long as selling medical devices in Brazil.

The Brazilian registration holder will be responsible for maintaining the registration in the duration of its validity, and the manufacturer and its designated distributor will have exclusive use of this record and service.

5. Registration Language

English + Portuguese

Chapter 2 Registration Flow, Cycle & Official Fee

1. Registration Flow

2. Registration Approach

3. Registration Cycle and Official Fee

Chapter 3 FAQ

Q: How many opportunities are provided for supplementary information?

A: The medical device registration process is subject to procedural evaluation, reevaluation, audit, market supervision and inspection. If any inconsistency is found or additional information is required, the holder shall adjust it within 30 days; Corrections to previously submitted information are subject to a specific request; Failure to respond to the adjustment notice within 30 days may result in cancellation of registration.

Q: What are the requirements for BRH?

A: All manufacturers that do not have a physical office in Brazil must appoint a Brazilian agent as BRH, as only Brazilian companies can apply for product registration, and the certificate is held by BRH. BRH can be a business partner of the company in Brazil, a branch of the company in Brazil, or a consulting agency with a branch in Brazil. BRH must hold the qualification of business license AFE (Autorizacao de Funcionamento).

Q: Is it mandatory to register a medical device in ANVISA requiring the registration certificate of country of origin?

A: Registration certificate of country of origin is not required.

Q: Is it possible to speed up registration if having a GHTF record?

A: If there is approval from the European Union, the United States, Japan, Australia and Canada, it can influence the audit process of the Brazilian authorities.

Q: If the manufacturer has the MDSAP system certificate, does it still require to apply for BGMP?

A: Manufacturers must obtain Brazilian Good Manufacturing Practice (BGMP) certification prior to product registration for Class III and Class IV medical devices. The MDSAP certificate is only a good reference for accelerating GMP certification approval, but it does not replace it. If there is a MDSAP certificate, only the document audit can be carried out, which is most likely to eliminate the BGMP on-site audit.

Q: What is INMETRO certification?

A: Certification of electronic medical devices by the National Institute for Metrology, Standardization and Industrial Quality (INMETRO). The certificate is valid for no validity period and INMETRO certification is carried out by a product certification body or OCP (e.g. SGS, TUV Rheinland, UL). As with medical device registration, INMETRO certification requires a licensed BRH, and foreign manufacturers cannot obtain INMETRO certification on their own without a local representative in Brazil. As part of the registration of medical devices, all applicable products must provide a notarized copy of their INMETRO certificate with the registration application.

Q: Is the certificate of registration transferable?

A: In accordance with RDC Resolution 102/2016, transfer of ownership will be considered a new registration procedure.

Q: How long is the Brazilian registration certificate valid?

A: ClassI&II permanently valid; ClassIII&IV is valid for 10 years.