Medical Devices

Medical devices, commonly known as health products in Brazil, are defined by the Brazilian Health Regulatory Authority (ANVISA) as any instrument, device, equipment, implant, medical device for in vitro diagnosis, software, material, or other article, intended by the manufacturer to be used in human beings, for medical purposes, and whose main 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 means of prevention, diagnosis, monitoring, treatment, rehabilitation, or contraception (ANVISA Resolution RDC 751/22 “Resolution 751”). Medical devices are divided into different categories, such as in vitro, diagnostics, medical equipment, orthopaedic implants, and health materials.

Medical devices are subject to ANVISA’s health oversight. Before a product’s manufacture, import, or sale on the Brazilian market, a company must secure a marketing authorisation from ANVISA.

Authorisations are subject to slightly different procedures by ANVISA, depending on product risk types and according to the classification outlined in Resolution 751.

• Class I and II (low and medium risk, respectively) products are subject to prior filing with ANVISA, and authorisation is valid indefinitely. Class I and II products include orthodontic products, adhesive tapes, bandages, contact lenses, and disposable needles and syringes.
• Class III and IV (high and maximum risk, respectively) products are subject to registration with ANVISA, and authorisation is valid for ten years. Class III and IV products include anaesthesia kits, catheters, orthopaedic fixation systems and associated devices, hearing implants, and stents.

For products ranked under classes I and II, the interested party is responsible for complying with the applicable rules established in Resolution 751 and ranking the relevant product in its appropriate category.

Software-based medical devices (or “Software as a Medical Device” – SaMD) are also subject to health oversight and require authorisation from ANVISA, as provided for by Resolution RDC 657/22 (“Resolution 657”).

Resolution 657 outlines situations in which SaMD will require a separate authorisation and those in which it is covered by the medical device’s authorisation.

Software promoting well-being, as well as health-related financial and administrative software and demographic and epidemiological medical data processing software, are not covered by Resolution 657 and require no authorisation for the Brazilian market.

Personal Protective Equipment (PPE)

ANVISA oversees the regulation and sale of PPE in Brazil only if such equipment is used in health-related activities, such as use by healthcare professionals and on a manufacturing production line.

The Brazilian labour ministry regulates other types of PPE (used by non-health-related workers). In this context, Rule 6 generally governs the execution of PPE work without reaching specific sectors such as health.

Medical Instruments

Considering ANVISA’s broad definition of “medical devices”, medical instruments are governed by the same rules and principles as medical devices, as noted in Resolution 751.

Medical instruments may also be regulated by the National Metrology, Standardisation, and Industrial Quality Body (the “Body”), an entity linked to the National Institute of Metrology, Quality, and Technology (the “Institute”).

The Institute regulates products and services related to safety and the protection of human, animal, and plant life, health and environmental protection, and the prevention of deceptive trade practices.

If a particular medical instrument is subject to the Body’s oversight, an interested party must secure (before the sale in Brazil) a certificate from the institute that confirms adherence to Brazilian metrology, quality, and technology standards.

Cosmetics

Cosmetics are subject to regulation and supervision by ANVISA and are divided into two categories.

• Grade 1 – personal hygiene products, cosmetics, and perfumes, the content of which meets the definition in Resolution RDC 752/22 (“Resolution 07”) and not consisting of primary or elementary properties. Given the product’s intrinsic characteristics, no proof of this is required initially, nor is detailed information on use and use restrictions,.
• Grade 2 – personal hygiene products, cosmetics and perfumes, the content of which also meets Resolution 752, with specific instructions. Proof of safety and/or effectiveness and information on use, care, means, and restrictions are required.

As defined in Resolution 752, some products require authorisation, valid for ten years. They are suntan lotion, antiseptic hand gel, hair straightening and dyeing products, hair curling products, sunscreen, and insect repellent.

Resolution 752 also establishes mandatory labelling criteria for cosmetics, including product name and category, brand, registration number, batch, expiration date and country of origin, as well as information on the manufacturer/importer, method of use (if applicable), warnings and use restrictions (if applicable), and ingredients/composition.

Biocides

For regulatory purposes, Brazil does not accept “biocide” as a specific product category subject to oversight and regulation by health authorities.

“Biocide” covers different products in Brazil, depending on their features, composition, and purpose, and includes cosmetics, sanitisers, pesticides, and disinfectants.

Sanitisers fall within a different product category under ANVISA’s purview and are considered substances or preparations for application on objects, fabrics, inanimate surfaces, and environments (ANVISA RDC Resolution 59/10). They are intended for cleaning, hygiene and disinfection and are classified according to their risks.

• Risk I – Products that:
1. present oral LD50 for rats greater than 2,000mg/kg of body weight for liquid products and more than 500mg/kg of body weight for solid products;
2. have a pH value greater than 2 but less than 11.5 in pure form at a temperature of 25°C;
3. do not present corrosivity, anti-microbial activity, or disinfectant action, and are not based on viable micro-organisms; and
4. do not contain one of the following inorganic acids in their composition: hydrofluoric acid (HF), nitric acid (HNO₃), sulphuric acid (H₂SO₄), or salts that release those acids when using the product.
• Risk II – Products that:
1. present oral LD50 for rats greater than 2,000mg/kg of body weight for liquid products and more than 500mg/kg of body weight for solid products;
2. have a pH value that is equal to or less than 2 or equal to or greater than 11.5 in pure form at a temperature of 25°C;
3. present corrosivity, anti-microbial activity, or disinfectant action, or are based on viable micro-organisms; or
4. contain one of the following inorganic acids in their composition: hydrofluoric acid (HF), nitric acid (HNO₃), sulfuric acid (H₂SO₄), or salts that release those acids when using the product.

Risk I sanitisers are subject to simple prior notice to ANVISA before the sale. However, Risk II sanitisers require a previous marketing authorisation from ANVISA.

Food and Nutrition Supplements

Food is regulated mainly by two entities:

• the Ministry of Agriculture and Livestock (“Agricultural Ministry”); and
• ANVISA.

The Agricultural Ministry regulates animal products, beverages, and fresh vegetable products. ANVISA regulates and reviews processed foods in general, food additives and technology aids, packaging, equipment, and devices in contact with food. ANVISA also inspects food in commerce.

Depending on the type of food, the establishment and the food itself may have to be registered with the Agricultural Ministry.

ANVISA lists the foods subject to registration in Exhibit II of Resolution RDC 27/10 (“Resolution 27”). Registration is valid for five years. Foods exempt from registration but subject to notification of the Local Health Surveillance Authority are listed in Exhibit I of Resolution 27. Procedures are laid out in Resolution RDC 22/00 and Resolution RDC 23/00. ANVISA also determines the technical regulation of food (ie, the identity and minimum quality characteristics of some food).

Food with genetically modified organisms (GMOs) must follow specific procedures for approval, precisely in adherence to Law 11,105/05 and Decree 5,591/05. As a result, food with GMOs must be approved by the National Technical Biosafety Commission (the “Commission”) and remains subject to regulation and supervision of the Agricultural Ministry and/or ANVISA. As for labels disclosing information on GMOs, Decree 4,680/03 states that food and food ingredients intended for human or animal consumption that contain or are produced from GMOs or GMO by-products must include that information on their labels. Previously, only products with GMO content above 1% were required to include that information on labels. However, in light of Brazilian court decisions, labels must disclose any percentage of GMOs present to respect consumers’ right to information.

In Brazil, nutritional supplements (“supplements”) are classified as food and are thus subject to regulation and supervision by ANVISA if they contain enzymes or probiotics (Exhibit II of Resolution 27). For supplements without enzymes or probiotics, a notice of intent to sell must be given to the Local Health Oversight Authority (Exhibit I of Resolution 27). The technical requirements for supplements are found in Resolution RDC 243/18, including identity, minimum quality characteristics, and labelling.

Drugs

Drugs or medicines are also subject to regulation by ANVISA, meaning that before manufacture, import, and sale on the Brazilian market, an interested party must first secure authorisation.

Drugs are divided into various categories.

• Branded – an innovative drug.
• Generic – drugs with:
1. an identical pharmaceutical active ingredient, quantity, and form when compared to the branded drug;
2. interchangeability, as evidenced by bio-equivalence studies; and
3. no brand.
• Similar drugs with:
1. an identical pharmaceutical active ingredient, quantity, and form when compared to the branded drug;
2. interchangeability, evidenced by bio-availability studies; and
3. a brand.
• Biological – drugs with complex molecules of high molecular weight obtained from biological fluids, tissues of animal origin or biotechnological procedures through the manipulation or insertion of other genetic material (recombinant DNA technology) or gene modification.
• Herbal – drugs obtained exclusively from active raw materials from plants, with constant quality features and the safety and efficacy of which are based on clinical evidence.

All such categories must comply with the general good manufacturing practices (“practices”) set forth in Resolution RDC 658/22 (“Resolution 658”). Depending on the category, additional practices may apply. For instance, a manufacturer of herbal drugs must also comply with Regulation 130/22 (additional practices for herbal drugs), whereas a biological drug manufacturer must also adhere to Regulation 127/22 (additional practices for biological drugs).

Each drug category must follow specific health rules and, more specifically, valid registration rules. Drug registrations may be valid from five to ten years, depending on the number of times a particular product registration has been renewed (Resolution RDC 317/19).

Drugs requiring a doctor’s prescription are divided into two different groups: over-the-counter (OTC) and prescription, including those covered by regular prescriptions, special control, and prescription retention. Different dispensing and labelling rules exist for each category of drugs.

OTC drugs are subject to less rigorous requirements on their sale, while drugs subject to prescription retention have the strictest rules. Resolution RDC 98/16 sets out the criteria for classifying drugs as OTC:

• minimum time period of sale in Brazil and/or abroad;
• potential for low harm;
• treatment of non-serious illnesses and symptoms;
• short treatment period;
• ease of handling and taking; and
• zero risk of addiction.

ANVISA Regulation 120/22 lists all OTC drugs in Brazil.

On the other hand, drugs subject to prescription retention must comply with much stricter rules. Regulations 344/98 and 06/99 establish the applicable criteria, including stringent rules on the marketing, transport, inventory, prescription, sale, and bookkeeping activities for drugs and special controlled substances.

After obtaining the relevant authorisation, drug prices must be determined by the Drug Market Regulation Chamber (the “Chamber”). The Chamber is a joint ministerial body in charge of regulating the economic aspects of the drug market in Brazil.

The Chamber sets limits on drug prices, adopts rules that encourage competition in the sector, monitors sales and applies penalties when its rules are not followed. It is also responsible for setting and monitoring the application of the mandatory minimum discount for public purchases.

Drug prices are reviewed annually by the Chamber and, after deliberation, adjustments are authorised and companies may implement such adjustments, as long as they remain within the limits. During the COVID-19 pandemic, Brazil faced political interference in drug prices for the first time since the Chamber’s creation. In 2020, the Brazilian government temporarily suspended annual drug price adjustments through Provisional Measure 933/2020.

Blood Products

In Brazil, blood products must comply with the same rules and are considered biological products according to ANVISA Resolution RDC 55/10. Given that classification, blood products are subject to more complex and strict rules than non-biological drugs or medical devices.

Advanced Therapy Products

Advanced therapy products are a particular category of new drugs derived from advanced cell therapy, engineered tissues, and gene therapy. ANVISA Resolution RDC 505/21 (“Resolution 505”) sets out criteria and rules for securing authorisations for such products.

Before manufacturing, importing or selling such products in Brazil, the interested party must secure the relevant market authorisation by Resolution 505.

According to Resolution RDC 506/21, clinical trials for advanced therapy products must comply with different and specific rules on clinical trials.

Psychedelics

The medicinal use of psychedelics is a trending topic in Brazil. Some psychedelic substances are listed in the “F” List of Resolution 344/98 as forbidden, meaning they cannot be used in Brazil.

A successful case is the endorsement of ANVISA for medicine with the pharmaceutical ingredient ketamine hydrochloride. This pharmaceutical ingredient is derived from ketamine, an allowed psychedelic in Brazil. The medicine is a nasal spray to treat severe depression that can be used only in a hospital or a specialised clinic and in the presence of a health professional. The approval of this medicine is the leading case of psychedelics in Brazil.

On the other hand, there is a legal gap between the medicinal use of mushrooms and the substances we find in them (such as psilocin and psilocybin). The substances are prohibited in Resolution 344/98, but the mushrooms containing them are not forbidden. Some companies are using this legal gap to market the mushrooms themselves, but they are being questioned by the authorities, especially the Brazilian police.

Cannabidiol (CBD)

CBD-based products for medicinal use are subject to regulation and oversight by ANVISA.

ANVISA Resolution RDC 327/19 (“Resolution 327”) establishes rules (including authorisations) for the sale of CBD-based products. Based on Resolution 327, CBD-based products must mainly contain cannabidiol and no more than 0.2% tetrahydrocannabinol (THC).

CBD-based products are scarce and often difficult to obtain in Brazil, given limited sales and a broad taboo among the general public and the authorities. In light of this scarcity and its damage to patient treatments and protocols, ANVISA recently issued Resolution RDC 660/22 (“Resolution 660”), which allows individuals to import CBD-based products as an exception for personal medicinal use.

While Resolution 660 does not impose minimum limits on imported CBD-based products, it does mandate the product’s registration before the competent authorities in the country of origin.

Medical Apps

Depending on the purpose of medical apps, products could be subject to regulation and supervision by ANVISA. As an example, a medical app classified as SaMD must follow Resolution 657 and could be required to register with ANVISA.

The Federal Council of Medicine (the “Council”) may also govern a medical app. This is the case with apps that offer medical consultation at home. According to Council Resolution 2,178/17 (“Council Resolution 2,178”), the company responsible for the app must be registered with the council and a physician technical director must be identified. Council Resolution 2,178 also imposes duties on physicians registered on the app.

Tele-medicine

Telemedicine is regulated by Resolution CFM 2,314/22, which authorises seven types of tele-medicine:

• tele-orientation;
• tele-diagnosis;
• tele-monitoring;
• tele-inter-consultation;
• tele-surgery;
• tele-screening; and
• tele-visits.

Foreign medical physicians and companies may only engage in tele-inter-consultations and tele-visits. All other types of tele-medicine require medical physicians and companies certified by the council.

Wearables

Depending on the purpose of wearables, they may be classified as medical devices subject to regulation and supervision by ANVISA and requiring notice to be provided to that entity. More information on this can be found in 1.1 Medical Devices.

Stem Cells

The discussions on stem cells in Brazil are related to the use and research of embryonic stem cells. Law 11,105/05 allows research with embryonic stem cells obtained from human embryos produced by in vitro fertilisation and not used in a procedure since the embryonic stem cells are from non-viable embryos. In all cases, parental consent is required, and the research establishments must submit their research protocol with embryonic stem cells for approval before Brazilian ethics committees. On the other hand, Law 11,105/05 prohibits marketing embryonic stem cells and human cloning.

The Brazilian Federal Court of Justice (STF) discussed the research possibility under the claim of unconstitutionality of the allowance of Law 11,105/05. The STF authorised the scientific use of embryonic stem cells for therapeutic purposes.

Borderline products lack a simple and straightforward classification, mainly because they mix different health-related product characteristics, forms, and substances.

For example, dermocosmetics contain active pharmaceutical ingredients for one or more therapeutic activities. In that sense, they are much more similar to topical dermatological drugs.

The challenge remains to determine whether the product should be classified as a cosmetic or a drug. Usually, dermocosmetics are cosmetics that must be registered with ANVISA (Exhibit II of Resolution 27) because they require proof of safety and/or efficacy.

Another example is hyaluronic acid, a substance used in cosmetics for beauty procedures (for local injections) and medical treatments (for cataracts and osteoarthritis).

In Brazil, ANVISA classifies and treats hyaluronic acid as an acellular dermal graft, and thus among the highest-risk medical devices (class IV). Therefore, an authorisation must be granted by ANVISA.

Medical Devices

To manufacture medical devices, the manufacturer must hold a federal authorisation awarded by ANVISA and a sanitary licence (“licence”) granted by the Local Health Regulatory Agency (the “Agency”).

Manufacturing sites of medical devices classified as class III and IV (high and maximum risk, respectively) must also be audited and approved by ANVISA as a means of ensuring compliance with the practices enshrined in Resolutions RDC 665/22 and RDC 687/22.

ANVISA adhered to the Medical Device Single Audit Programme (the “Programme”) for inspecting subsidiaries. As a result, the Programme’s inspection report may be accepted as proof of compliance with the practices.

Drugs

To manufacture drugs, a manufacturer must also hold a federal authorisation from ANVISA and a licence from the agency.

ANVISA must also authorise all sites where manufacturing operations occur and shall grant certification upon inspection to ensure compliance with the practices described in Resolution 658. Depending on the drug’s classification, additional ANVISA requirements may apply.

Blood Products

As described previously, blood products are considered pharmaceuticals in Brazil and must adhere to the practices and terms of Resolution 658 and Regulation 137/22.

PPE

PPE consists of “any device or product, for individual use, used by the worker, intended to protect against risks likely to threaten safety and health at work” (Rule 6).

PPE must adhere to Social Security and Labour Regulation 11,347/20 (“Regulation 11,347”). Technical requirements for PPE are described in the attachments of Regulation 11,347. Similarly, PPE may be reviewed by the Body.

The PPE manufacturer must obtain an approval certification (CA) issued by the labour authority, which is valid for five years.

Medical Instruments

If the medical instrument is classified as a “medical device”, the manufacturer must obtain a federal authorisation from ANVISA. Similarly, manufacturing sites may need to follow the practices and receive certification from ANVISA, as described above.

Cosmetics

To manufacture cosmetics, the manufacturer must hold a federal authorisation granted by ANVISA and a licence awarded by the agency. All related manufacturing sites must also follow the practices outlined in Resolution RDC 48/13.

Biocides/Sanitisers

The manufacturer of sanitisers must hold a federal authorisation from ANVISA and a licence from the agency. All related manufacturing sites must also comply with the practices established by Resolution RDC 47/13.

Food and Nutrition Supplements

The manufacturer of food and nutrition supplements must hold a licence granted by the agency. All manufacturing sites must also comply with the practices outlined in Regulation 326/97 and Resolution RDC 275/02.

Cannabidiol (CBD)

As provided by Resolution RDC 327/19, the manufacturer of a CBD-based product must hold:

• a federal authorisation from ANVISA for manufacturing pharmaceuticals;
• special authorisation granted by ANVISA; and
• a certificate of practice for pharmaceuticals.

While planting and harvesting cannabis sativa (subspecies) for personal or commercial use remains prohibited in Brazil, patient associations may seek authorisation by the court for such activities under certain circumstances.

The National Solid Waste Policy (Law 12,305/10) is the primary legal framework governing the life cycle of products, including those related to health, such as pharmaceuticals, electro-medical products, and their packaging.

Accordingly, all manufacturers, importers and traders must adopt measures and actions aimed at reducing, reusing, recycling, and treating solid waste resulting from their activities, while ensuring their environmentally appropriate disposal, including implementing reverse logistics for electrical and electronic equipment, pharmaceuticals, and packaging.

States may also pass more restrictive rules and quantitative and qualitative targets for reverse logistics systems, governing the private sector, regardless of public garbage collection services.

Furthermore, the country’s National Solid Waste Policy calls for the private sector to implement consumer environmental education programmes. Failure to adhere to existing legislation may result in the rejection of applications to obtain and renew operating licences and orders to pay compensation for environmental damage caused and potential criminal penalties.

Health products subject to oversight may be advertised. Specific rules such as Resolution RDC 96/08 may apply, which establishes the requirements for advertising pharmaceuticals. Only pharmaceuticals approved by ANVISA may be promoted, and the advertisement must reflect the product’s registration. No off-label uses are allowed, and the piece must be considered an advertisement (ie, no indirect advertisements are permitted).

Only product claims previously authorised by ANVISA may be used. For example, Regulation 28/18 provides that claims previously authorised by ANVISA may be raised in supplements. As a result, a company may use those claims without seeking ANVISA’s approval. Similarly, a company may use another claim approved by ANVISA upon analysing the product’s registration.

From an environmental perspective, Brazilian legislation does not include any specific medical device or health product provision. To avoid accusations of greenwashing and related legal and reputational risks, Consumer Defence Code (Law 8,078/90) rules prohibiting misleading and abusive advertising apply.

Health products subject to oversight must receive government approval before their sale. The company must also prove the product’s safety and effectiveness, with requirements varying based on their categories and classifications, if applicable. Given the clinical trials and technical evaluation required, medical devices and pharmaceuticals are considered the most complex products covered.

Some product categories are divided into two main groups: those subject to registration and those for which notice must be given to the authorities. Medical devices, cosmetics, sanitisers, food and nutrition supplements are covered, and product registration requirements are stricter for those products presenting higher risks and looser for products offering fewer risks. For example, foodstuffs are considered less harmful than pharmaceuticals but must still be registered with ANVISA, and a company must prove their safety and effectiveness.

For more detailed information, please refer to previous chapters.

Investing in Brazil depends on various connected factors, including the company’s size, cost and availability of raw materials, cost of manufacturing finished products, tax regimes and incentives, labour costs, bureaucracy, and size and maturity of the internal market and logistics, as well as secondary considerations such as political uncertainty that may generate legal insecurity.

The regulatory regime also determines the outcome, as Brazil has strict regulatory rules and controls. ANVISA closely emulates the regulatory regimes of foreign agencies, such as the US Food and Drug Administration (FDA) and the European Medicines Agency. ANVISA has also entered into international co-operation agreements with other regulatory agencies, such as the FDA, and shares information on companies and products with those regulatory partners.

After introduction to the market, medical devices and health products must continue to be monitored by the responsible company to detect any possible deviation from safety and effectiveness. All investigatory records must be kept by the company for a period corresponding to the product’s category.

In case of deviation, a company may initiate a field action or recall procedure. To choose one or the other, the company must review its legal options and requirements in accordance with the product’s rules. For instance, a field action procedure may be undertaken with medical devices, in accordance with Resolution RDC 551/21. On the other hand, a recall procedure covers a range of products (medical devices, pharmaceuticals, foodstuff, etc).

Proceedings must be brought as soon as possible (whenever sufficient evidence or proof of deviation exists) to minimise health risks.

All procedures are subject to notification to authorities, especially ANVISA and consumer protection bodies. Time limits for notification depend on the product and the seriousness of the situation.

These regulatory authorities oversee health-related products:

• ANVISA – the Brazilian National Health Regulatory Agency;
• MAPA – the Ministry of Agriculture, Livestock and Supply;
• CFM – the Federal Council of Medicine; and
• INMETRO – the National Institute of Metrology, Quality, and Technology.

The entities mentioned in 3.1 Regulatory Authorities strictly enforce existing legislation by determining companies’ adherence to rules and regulations.

In Brazil, regulatory enforcement mechanisms vary from affirmative obligations to a precautionary ban on granting or suspending a product’s registration, with the approach depending on a specific case analysis. Aspects generally evaluated include mitigating circumstances, such as the offender’s good faith, and aggravating circumstances, including the offender’s bad faith actions. Other factors cover the seriousness of the facts, the consequences for public health and the offender’s background (ie, first offender or repeat offender).

A precautionary mechanism may be transformed into a definitive mechanism (such as a penalty) after an administrative proceeding at which the company is heard.

Typical administrative product safety offences are defined in Law 6,437/77 and include:

• the manufacture, import, and/or sale of products subject to health oversight without authorisation or with failure to comply with ANVISA rules;
• the manufacture, import, and/or sale of products under health oversight without authorisation or with a suspended or revoked licence;
• promotion of health products under oversight that does not adhere to marketing rules, particularly pharmaceuticals outside approved ANVISA indications (off-label use);
• labelling health products under oversight in breach of the rules, mainly foodstuffs and supplements;
• lack of compliance with quality controls and good practices involving manufacturing, import, and/or sales; and
• fraudulent, falsified, or adulterated health products under oversight.

Penalties are only imposed after holding an administrative proceeding at which the company is heard and has a right to appeal administrative decisions. If the company deems the administrative decision illegal, it may bring the challenge before Brazilian courts. The question remains whether the decision must be appealed administratively or submitted immediately to the courts.

Administrative offences may lead to civil and criminal investigations with the company’s director and the supervising technician responsible for the criminal offence.

The Brazilian Consumer Code (Law 8,078/90) provides for strict liability (a company is liable for its actions, regardless of intent or guilt) in consumer claims for damages caused by a defective product.

Under the Brazilian Consumer Code, all companies involved in the production chain (including the manufacturer, importer, distributor, and seller) are jointly and severally liable for damages caused by a defective product. A consumer may sue one or all companies forming the chain of production. If just one company is sued, that company may seek indemnity from the company found liable for the damage. The selling company may also be held responsible when the manufacturer, importer and/or distributor are not identified.

The company may avoid liability by demonstrating and proving that the defect or damage does not exist, that the product was not made available on the market, or that the defect or damage is the sole fault of the consumer/third party. The burden of proof applies when the patient/consumer has difficulty proving the evidence submitted through ordinary methods.

In general, technological advancements in medical devices do not impact the application of product liability law. Brazilian authorities apply the law, suiting it to a particular case. The scenario involving legislators is similar: legislators do not seek to create new rules because of technological advancements. However, if the technology promotes national commotion or fear, legislators tend to develop, approve, and enact laws faster – eg, during the COVID-19 pandemic, there was a discussion about the use and regulation of tele-medicine. By then, as the council had no contemporary tele-medicine rule, the legislators opted for regulating tele-medicine in Brazil (Law 13,989/20 – valid only during the COVID-19 pandemic).

Jurisdiction over disputes related to private parties’ rights lies with the ordinary civil court:

• lower courts for minor and low-value claims;
• civil trial courts;
• courts of appeal; and
• the Superior Court of Justice or the Federal Supreme Court as the court of last recourse.

Administrative courts have jurisdiction over disputes regarding the individuals’ legitimate interests in response to government acts, orders, and decisions:

• if state administration is at issue, the dispute is heard by the ordinary civil courts; and
• if the federal government is at issue, the dispute is heard by the administrative courts (federal justice at the trial level; federal, regional court at the appeal level; and the Superior and Supreme Courts at the highest level).

In theory, a losing party is responsible for paying the prevailing party’s legal costs and fees, including attorney fees, by the Brazilian Code of Civil Procedure (Law 13,105/15). However, the judge may also decide to fully or partially offset the parties’ costs.

Government acts, orders and decisions may be challenged before the courts. The Federal Court of Justice in Brazil has jurisdiction over matters related to ANVISA, the Institute, and the Ministry of Health. Decisions may be appealed to Brazilian courts.

There are many examples of challenges by pharmaceutical companies to ANVISA determinations and decisions in Brazilian courts, such as illegal conduct by ANVISA in imposing rigorous requirements for granting an authorisation, delays in issuing licences, and/or approving an importation proceeding.

The class action is provided for in Law 7,347/85 and applies to illicit conduct related to diffused or collective interests, often involving environmental, consumer, and health rights. A class action may seek to recover damages or enforce an obligation to act or omit.

When brought by the Attorney General’s Office, a class action is usually preceded by an administrative investigation to collect evidence of the illegal act to be challenged therein. If the Attorney General’s Office finds no illegality, the administrative investigation concludes without the need for such action.

A meaningful health-related class action was brought by the Federal Attorney General and a consumers’ association to assert consumers’ right to know the presence of GMOs in foodstuffs. The class action was approved, and companies were required to declare the presence of GMOs in foods on labels, regardless of their percentage.

Available alternative dispute resolution mechanisms include arbitration and mediation, with the help of an independent and impartial individual. While arbitration offers a specific means of evaluating a situation, mediation only involves negotiation.

Compared to litigation claims filed before Brazilian courts, arbitration renders a more technical and faster judgment, albeit with higher costs. Arbitration decisions typically bind Brazilian courts, with rare exceptions.

Product liability cases may also generate consumer, criminal, and/or administrative liability, especially when damages arise from insufficient quality or adherence to safety requirements or when they result from intentional acts or negligence.

Consumer liability will be found when a product has a defect that damages a consumer’s health. For more information, see 4.2 Product Liability.

Criminal liability will be assessed when the product lacks identity and quality, and the conduct is deemed a falsification, manipulation, adulteration, or alteration of the product. In that case, the criminal proceeding will be brought against the responsible technician and/or the company’s legal representative.

In the administrative field, liability will be found when the product deviates from quality or safety standards. Government authorities will initiate an administrative proceeding to assess the deviation and determine if it resulted from an individual or company’s intent or whether the individual or company was otherwise responsible for it.

ANVISA has the authority to enter (and has entered) into co-operation agreements with other Brazilian agencies on the exchange of information to assess any breach of the legislation, most notably a deviation in quality or safety by health products that may damage a consumer’s health.

ANVISA always seeks to review regulations when it has evidence of its delay or a significant difference between Brazilian and international regulations.

One recent example of this discrepancy is the regulation update involving SaMD. ANVISA changed the existing rule regulating the issue by international practices and promoting more excellent implementation by companies.

Another example is health digitalisation, a development accelerated by the COVID-19 pandemic. Government authorities, namely the Council and the Ministry of Health, are publishing new rules on tele-medicine and tele-health to digitally modernise the health system. That move should promote a more efficient, safe, and reliable health system with improved patient health and safety.

After the National Solid Waste Policy (Law 12,305/10) became effective, Brazilian states and municipalities adopted regulatory frameworks to expand the scope and goals of reverse logistics systems, resulting in a more complex operational compliance environment throughout Brazil.

Other legislative initiatives aim to curb first-use plastics by the consumer goods industry, while introducing a more comprehensive range of products and packaging in reverse logistics systems. Several environmental control bodies, including the Attorney General’s Office, have brought suits alleging civil and criminal liability actions to force companies to comply with reverse logistics obligations and reduce the environmental impacts resulting from consumer waste, including, most recently, the improper disposal of waste in the environment.

Several health-related legislative initiatives are on the horizon. ANVISA determines its regulatory agenda every two years and decides on its legislative and enforcement health oversight priorities based on internal proceedings approved by its board of directors. ANVISA’s 2021–2023 regulatory agenda currently spans 158 topics, with ten finalised, 13 excluded, and 9 incorporated as initially presented.

The following are examples of initiatives under ANVISA’s competence.

• A regulation on clinical trials with pharmaceutical and medical devices is under review by the agency. The main objective is simplifying the proceedings to speed up analysis by ANVISA (reduction of deadlines).
• A regulation about CBD-based products is also under review, as outlined in Resolution RDC 327/19.

It is difficult to assert and establish the impacts of artificial intelligence (AI) in the use and development of health products. At first, it is common to associate AI with developing and analysing patient data in medical devices. However, the scenario is much more extensive.

In Brazil, some bills discuss the use of AI in a broader manner. As such, Bill 2,338/23 (the “Bill”) is at the Brazilian Senate, and seems to be more complete and current. The Bill:

• defines fundamentals and principles for the development and use of AI systems;
• protects the rights of people affected by AI systems;
• categorises the risks, and imposes a preliminary assessment;
• defines high-risk applications;
• enforces systems governance; and
• establishes the rules of civil liability.

The use of AI in health products, including those intended to aid diagnosis and medical procedures, is categorised as high risk, being subject to stricter control standards. It is impossible to confirm when the Bill will become Law. Similar matters took years to be discussed by the legislators and to become effective in Brazil.