Brazil Medical Device Regulations

Regulatory Agency

National Health Surveillance Agency (ANVISA) is responsible for regulating medical devices in Brazil.
National Institute of Metrology Standardization and Industrial Quality (INMETRO) is responsible for assessing the conformity for active medical devices.
National Telecommunications Agency (ANATEL) is responsible for the certification and approval of medical devices that contain communication via Bluetooth, wireless or mobile data.
National Nuclear Energy Commission (CNEN) is responsible for licensing and authorizing activities involving the use of ionizing radiation.
National Research Ethics Commission (CONEP) analyzes and approves clinical research protocols involving medical devices.

Medical Device Definition

Medical Device (Medical Product): Any instrument, apparatus, equipment, implant, in vitro diagnostic medical device, software, material, or another article, intended by the manufacturer to be used, alone or combined, in human beings, for any of the following specific medical purposes, and whose main action intended action is not achieved by pharmacological, immunological or metabolic means in the human body, but which may be aided in its intended action by such means:

-diagnosis, prevention, monitoring, treatment (or alleviation) of a disease);
-diagnosis, monitoring, treatment, or repair of an injury or impairment;
-investigation, replacement, or alteration of the anatomy or of a physiological or pathological process or state;
-support or maintenance of life;
-control or support of conception; or
-provision of information through in vitro examination of samples from the human body, including organ and tissue donations.

Active Medical Device: any device whose operation depends on a source of energy not generated by the human body for that purpose, or by gravity, and which acts by changing the density or by converting that energy, except those intended to transmit energy, substances or other elements between an active device and the patient without producing any significant change.

Active Medical Device for Diagnosis and Monitoring: any active device used alone or in combination with other devices to provide information for the detection, diagnosis, monitoring, observation or treatment of physiological states, health conditions, diseases or congenital malformations.

Active Therapeutic Medical Device: any active device used alone or in combination with other devices to maintain, modify, replace or restore biological functions or structures in the context of a treatment or mitigation of a disease, injury or disability.

Single-Use Medical Device: a device intended to be used on one person during a single procedure, as specified by the manufacturer.

Family: grouping of medical devices, for the purpose of notification or registration, provided for in specific regulations, where each product has similar technical characteristics of:

1. Indication, purpose of use;
2. Functioning and action;
3. Technology;
4. Content or composition, when applicable; and
5. Precautions, restrictions, warnings and special care.

According to Art. 4 of the resolution RDC No. 751/2022.

Kit (set or tray): set of medical devices that, regardless of being registered or notified individually, are grouped in a sales unit for a specific purpose of use or procedure:

1. for regularization purposes, the set must be from the same manufacturer or manufacturing group; and
2. the components of a medical device kit, in isolation, do not maintain an interdependent relationship to obtain the intended functionality and performance.

System: set of compatible medical devices, which relate or interact with each other, exclusively with the aim of fulfilling a purpose intended by the manufacturer.

Medical Device Classification System

International Classification	Risk Level	Examples
Class I	Low risk	Bandages, elastic bandages, and simple crutches.
Class II	Medium risk	Surgical instruments, dental drills, and diagnostic imaging equipment.
Class III	High risk	Ophthalmic laser, orthopedic plates and screws, and silicone implants (other than breast implants).
Class IV	Maximum risk	Pacemakers, artificial heart valves, implantable defibrillators, radiation therapy equipment, and extracorporeal circulation devices.
Note: All Medical Devices and In Vitro Diagnostics must be classified according to the 22 Risk Classification Rules.

Regulatory Approval Process

Classification	Approval procedure
Class I, II, III, and IV	Manufacturer or Importer must register at the sanitary vigilance and have an AFE (Operating permit license). Submit the Electronic Petitioning at Solicita system (https://solicita.anvisa.gov.br). Electronic Petitioning is the request made to ANVISA where all the documents should be uploaded electronically without the need to send the paper documents. You will receive the receipt of the petition by ANVISA known as an electronic protocol. ANVISA will review the application for notification and issue a statement. Brazil Good Manufacturing Practices Certificate is required for products under registration(class III and IV) and is issued after ANVISA inspection. Manufacturers that have joined the MDSAP program can benefit from the certificate to speed up the GMP Certification process by ANVISA, in addition to a longer certification validity period (four years, compared to two years for companies that have not joined the MDSAP) If approved, for Class I and II devices, information will be available on the ANVISA website. For Class III and IV devices ANVISA will publish the registration number in the DOU (Diário Oficial da União) Official Journal of the Union.


Notes: The applicant must appoint a Brazil Registration Holder (BRH). The National Institute of Metrology, Standardization, and Industrial Quality (INMETRO) certification is required for certain types of devices where technical standards have been established. MD-IVDs Classes I and II are subjected to a notification. MD-IVDs Classes III and IV are subjected to registration.

Additional Information

Approval timeline

MD and IVDs Class I & II: 30 days; MD and IVDs Class III & IV: 250 days. GMP Certification: 365 days. GMP by MDSAP: 180 days. The approval process can be delayed if additional information or testing is required.

License validity period

Class I & II:- Does not expire. Class III & IV : 10 years

Fees

Notification/Registration: Rates vary according to a company's economic size. Some examples are given in the table below: