Medical devices

What are medical devices?

According to Collegiate Board Resolution RDC No. 751/2022, a medical device is:

(...) any instrument, apparatus, equipment, implant, medical device for in vitro diagnosis, software, material, or other article, intended by the manufacturer to be used, either isolated or jointly, in humans, for any of the following specific medical purposes, and whose main action intended is not achieved by pharmacological, immunological, or metabolic means in the human body, but which can be assisted in their intended action by such means: a) diagnosis, prevention, monitoring, treatment (or relief) of a disease; b) diagnosis, monitoring, treatment, or repair of an injury or deficiency; c) investigation, replacement, alteration of anatomy or of a physiological or pathological process or state; d) support or maintenance of life; e) control of or support for conception; or f) supply of information through in vitro examination of samples from the human body, including organ and tissue donations.

Anvisa categorizes Medical Devices into four types: medical equipment, materials for health use, orthopedic implants, and in vitro diagnostic medical devices.

MEDICAL EQUIPMENT

Medical equipment subject to health regulation includes all health-related equipment intended for medical, dental, laboratory, or physiotherapeutic purposes, used directly or indirectly for the diagnosis, treatment, rehabilitation, or monitoring of human beings, as well as equipment intended for aesthetic purposes.

Most medical equipment consists of active medical devices, which may be implantable or non-implantable. However, there are also non-active medical devices classified as medical equipment, such as wheelchairs, stretchers, hospital beds, surgical tables, and examination chairs, among others.

Medical equipment is premarketing authorized in Brazil by two regimes: Notification, for Risk Class I (low risk) and II (medium risk) devices, and Marketing Authorization, for Risk Class III (high risk) and IV (maximum risk) devices, according to the classification rules provided for in RDC No. 751/2022.

The Notification of products categorized as Risk Classes I and II does not expire, but it may be cancelled upon request, in case of reassessment, in the impossibility of solving irregularities, or when fraud is detected. The Marketing Authorization for products categorized as Risk Classes III and IV is valid for ten years from the date of its publication in the Brazilian Federal Official Gazette and may be renewed for equal and successive periods.

For notification or marketing authorization of medical equipment, an ANVISA-regularized applicant company should observe the following specificities:

• According to RDC No. 549/2021, electromedical equipment and other specific medical equipment must compulsorily undergo a conformity evaluation under the Brazilian Conformity Assessment System (SBAC) scope before applying with ANVISA. A Product Certification Body accredited by the Brazilian Institute of Metrology, Quality, and Technology (INMETRO) is responsible for issuing the Conformity Certificate for each device and respective models. ANVISA defines the standards and respective versions by a Normative Instruction, which is periodically updated. The current version is Normative Instruction IN No. 283/2024.
• For medical equipment of Risk Classes III and IV, the manufacturing unit must hold a valid Good Manufacturing Practices (GMP) certificate issued by ANVISA. According to RDC No. 751/2022, ANVISA accepts the application protocol for GMP certification to apply for a device's marketing authorization. However, effective approval depends on the publication of the GMP certification.
• Risk Class classification of Software as Medical Device (SaMD) is defined by Rule 12 in RDC No. 751/2022. Also, RDC No. 657/2022 provides for specific instructions about SaMD, such as defining exception regulatory situations, mentioning specific considerations about labeling, instructions for use, and safety and performance requirements.
• Resolution RDC No. 579/2021 provides for the import, sale, and donation of used and refurbished medical devices to be used in Brazil. Used medical equipment intended exclusively for reconditioning in the Brazilian territory may be imported, but used or refurbished implantable devices cannot be imported, marketed, or donated. It is prohibited to import, to market, or to donate used or refurbished medical devices that do not meet the criteria established by that regulation.
• Finally, every medical device must comply with essential safety and performance requirements, in accordance with RDC No. 848/2024. This resolution defines the essential principles that should be kept under the entire life cycle of a device, from its initial conception until its decommissioning and final disposal.

HEALTHCARE PRODUCTS

This group includes surgical instruments and personal protective equipment (PPE), invasive access devices (such as needles, catheters, stents...) prostheses and other implantable devices, sutures, threads, solutions and their compounding derivatives, pre-filled syringes, wound dressings, condoms, blood bags, orthopedic and orthodontic materials, culture media for in vitro fertilization, tattoo pigments, and other accessories associated with medical devices.

For certain types of healthcare products, there are additional regulations that establish specific technical requirements to be included in the documentation dossier, such as certifications issued by the National Institute of Metrology, Quality and Technology (INMETRO), namely:

• Single-use transfusion sets, gravity infusion sets, and infusion sets for use with infusion pumps (RDC No. 539/2021);
• Hypodermic and dental needles (RDC No. 540/2021);
• Sterile single-use hypodermic syringes and plastic material (RDC No. 541/2021);
• Plastic bags for the collection, storage, and transfer of human blood and its components (RDC No. 544/2021);
• Surgical and examination gloves made of natural rubber, synthetic rubber, a blend of natural and synthetic rubber, and polyvinyl chloride (RDC No. 547/2021);
• Breast implants (RDC No. 550/2021);
• Copper intrauterine devices (IUDs) (RDC No. 552/2021);
• Male latex condoms (RDC No. 554/2024).

ORTHOPEDIC IMPLANTS

Although these products are still classified as medical devices, ANVISA groups those intended specifically for orthopedic procedures under the category of Orthopedic Implants, which includes:

• Implantable materials for bone fixation, such as: plates, screws, staples, flexible wires and cables, rigid pins and wires, intramedullary fixation rods, anchors for soft tissue-to-bone attachment, mandibular fixation devices, cranial bone flap fixation devices, halo-cranial fixation systems, and spinal implants.
• Implantable materials for partial or total joint replacement, including implants for hip, knee, shoulder, elbow, ankle, wrist, and temporomandibular arthroplasty.
• Bone grafts;
• Bone cements.

IN VITRO DIAGNOSTIC MEDICAL DEVICES

A medical device is an in vitro diagnostic medical device (IVD) if it is a reagent, calibrator, standard, control, sample collection device, material, or instrument, used individually or in combination, with an intended use specified by the manufacturer, for the in vitro analysis of human body-derived samples. These devices are used exclusively or primarily to provide information for diagnostic, monitoring, or screening purposes, predisposition, prognosis, prediction, or to determine compatibility with potential recipients of blood, tissues, organs, or cells.

This definition includes self-test products, which are intended for use by laypersons based exclusively on the instructions provided by the manufacturer. Self-tests allow for the monitoring of disease conditions and the detection of specific situations, with the purpose of assisting the patient. However, they are not considered conclusive for 4 diagnoses (note, certain IVD medical devices for self-testing are currently prohibited in Brazil).

The definition of an IVD does not cover in-house, research use only, or other products that are intended for general laboratory use that are not manufactured, sold, or presented for use specifically as an IVD.

The classification rules consider the intended purpose of the device, the level of risk to the user or public health due to an incorrect result.

The IVDs are classified into 4 risk classes:

• Class I – No public health risk or low personal risk
• Class II – Low public health risk or moderate personal risk
• Class III – Moderate public health risk or high personal risk
• Class IV – High public health risk

Some high-risk IVD medical devices are subject to performance evaluation made by an official laboratory to complement the verification and validation data submitted in the dossier for marketing authorization (initial issue, renewal, and for changes of composition, manufacture or to include a new product on a “family process” with previous authorization). It includes devices for HIV, Hepatitis B and C, Syphilis, Chagas disease, HTLV, Dengue, Chikungunya on many methodologies, and self-test for SARS-CoV-2 antigen.

The marketing authorization for higher risk devices (Classes III and IV) are called “registro” in Portuguese and correspond to an assessment of full product dossier (includes performance evaluation, labelling, images), company's licenses, GMP certification, LoA (Letter of Representative Authorization), if applicable and, in some cases, laboratorial performance evaluations. The marketing authorization is valid for 10 years and can be renewed for equal periods.

The conformity assessment should be demonstrated by reliance process with full documentation including the proof of regularization of the product by an Equivalent Foreign Regulatory Authority (EFRA) recognized by ANVISA. The final decision will be made by ANVISA considering the verification of product sameness (essentially identical) and compliance with other legal requirements.

The marketing authorization for lower risk devices (Classes I and II) are called “notification” made by abridged documentation. The notification is valid for an indeterminate period, exempt from renewal, and can be cancelled anytime by the company that holds the authorization (market interest) or by Anvisa if, for example, risk for users or any illegality is detected/confirmed.

A person or company who is legally responsible for supplying a device in Brazil is called a "detentor” (holder: company that holds the authorization).

Products with the same legal manufacturer, technology, methodology, and indication can be grouped into the same application if there is a corresponding option in the Normative Instruction IN No. 320/2024.

Information on definitions, risk classification, notification and registration regimes, labeling requirements and instructions for use of in vitro diagnostic medical devices, including their instruments, are provided for by Collegiate Board Resolution RDC No. 830/2023.

CLINICAL TRIALS

Clinical investigations — such as clinical trials — may be required during the marketing authorization and notification processes of health-related materials and equipment. The obligation to provide clinical evidence is established in RDC No. 56/2001, which defines the essential safety and efficacy requirements for health products. According to this resolution, especially for products classified under risk classes III and IV, these requirements must be supported by clinical data, which may be presented by:

a) a compilation of indexed scientific literature related to clinical research on the product's intended use, accompanied, when necessary, by a critical evaluation; or

b) the results and conclusions of a clinical investigation conducted specifically for the product in question.

In addition, RDC No. 40/2015, which addresses the requirements for the notification of medical devices, states in Paragraph 1 of Article 4 that ANVISA may require the submission of additional documents and information, particularly in cases involving public health risks or products considered strategic by the Brazilian Ministry of Health.

Clinical studies must follow ethical principles and international standards of Good Clinical Practices, in accordance with ISO 14155:2020. Studies conducted in Brazil must also comply with the guidelines established in RDC No. 837/2023.

Marketing authorizations

Marketing authorizations are issued by ANVISA depending on the risk classification of the medical device. Marketing authorizations for products categorized as Risk Classes I and II do not expire, but they might be cancelled upon request, in case of reassessment, in the impossibility of solving irregularities, or when fraud is detected. Pre-market approvals for products categorized as Risk Classes III and IV are valid for ten years from the date of their publication in the Brazilian Federal Official Gazette and may be renewed for equal and successive periods.

Please note that it is not possible for foreign companies to make administrative arrangements to be granted marketing authorizations directly from Anvisa. Foreign companies must have partner companies legally constituted in Brazil that will be legally responsible for the products imported into and distributed within the Brazilian territory.

Applicable regulations

These are the main regulations applicable relating to the marketing authorization of medical devices exported to Brazil: