Brazilian Regulation for Health Technology

Health technology is required to comply to a set of regulatory measures set by Anvisa, the Brazilian Health Surveillance Agency. In this article we will look at the regulations for health technology in Brazil and what the requirements are for companies to commercialize these products in the country.

Brazilian Health Technology market

The market for health equipment and technology in Brazil has expanded significantly over recent years, mostly pushed by the growth of private healthcare institutions in the country.

Some interesting data about the Brazilian health technology and medical equipment industry was published by Brazilian Health Devices, a sector project focused on providing intelligence and assistance for national companies who intend to export medical equipment to foreign markets, founded by ABIMO, or the Brazilian Medical, Odontological, Hospital and Laboratory Articles and Equipment Industry and APEX-Brasil, the Brazilian Trade and Investment Promotion Agency.

According to their research, this is a sector that reached USD 19.07 billion in value by 2013, of which 31.9% came from the national production of these types of equipment. Brazilian imports of medical devices heavily outweigh the size of exports, at USD 4,9 billion compared to the USD 737 million achieved by exports of nationally produced devices. Close to 60% of Brazilian companies in this sector are considered medium size, at between BRL 2.4 million and BRL 6 million in value, and 57% of all companies export as part of their commercial activities.

This data presents a scenario in which the Brazilian Health Technology market shows high potential for growth in the near future, but this expansion will unlikely be backed up by the national companies, due to the lack of expertise and infrastructure to produce high-tech equipment required by modern healthcare.

Another facet of health technology that shows potential for expansion both in Brazilian and global markets is the sector of fitness and personal healthcare devices which is mostly driven by wearable equipment like pedometers and heart rate monitors and are associated with health-related functions developed for devices such as smartphones and tablets. These wearable devices and technologies are currently not regulated by Brazilian institutions and serve a small audience of buyers who consume imported products.

Once these wearable devices and new technologies become known by the mainstream public in Brazil they will most likely be subject to the heavy and burdening regulations for health products, a factor that creates barriers for health product manufacturers to market their products legally on Brazilian territory.

The current requirements for companies to not only produce but also transport and commercialise health-related products, which includes technological equipment, from Brazilian Health Surveillance regulations are considerable and must be taken into consideration by companies who plan to serve the country’s market.

Regulation and medical product categories

The Brazilian Health Surveillance Agency, or Anvisa, establishes regulatory measures for “any products intended for medical, odontological, laboratorial and physiotherapeutic ends, used directly or indirectly for diagnosis, therapy and rehabilitation of human beings or even cosmetic or aesthetic purposes”.

This means that any private individual or company that intends to manufacture, commercialize, or import technology products in Brazil related to health must be compliant to Anvisa’s regulations or be subject to fines and other punishment measures instituted by the Federal Health Surveillance Legislation. Anvisa states that the process for product approval lasts an average of 90 days once the petition is started and all necessary documents and information has been provided.

There are two types of processes instituted by Anvisa for health equipment compliance. Medical Products under the agency’s regulation that present minor risks for humans must undergo a listing process to be included on the agency’s database, while products that present considerable risk must undergo a registration process under the Health Surveillance regime.

The amount of risk presented by medical products is classified by Anvisa in a category system that goes from I to IV. The agency institutes 18 rules for product categorization, which can be generalized in the following terms:

• Category I products: Non-invasive equipment that present minimal risk to humans, such as heart-rate monitors
• Category II products: Non-invasive equipment that present a considerable risk to humans, such as ultrasound scanners
• Category III products: Invasive products that present a high risk for humans, such as orthopedic surgical implants
• Category IV products: Invasive products with maximum risk for humans, such as pacemakers

All products in categories III and IV and some in lower categories that may present risk to humans are required to register equipment and products with Anvisa, while most products of categories I and II are only required to be listed on their database. All listed and registered products are granted an 11-digit number which can be used to check the equipments compliancy to Anvisa.

Petition Process

There are several requirements for companies to be eligible or require a petition for medical product listing or registering. Some of the documents necessary to start this process are:

• Autorização de Funcionamento da Empresa, or authorization by Anvisa for the companies to work on any activity related to medical products, including manufacturing, distribution and importing to Brazilian territory
• Licença de Funcionamento, or Alvará de Funcionamento, authorization for the company to operate in Brazilian territory issued by municipal or state Health Surveillance institutions
• Boas Práticas de Fabricação e Controle, the certificate of the company’s compliance to medical product manufacturing and control standards emitted by Anvisa, which demands local inspection by the Health Surveillance institutions or Anvisa technicians for companies in Brazil and directly by Anvisa for companies located in other territories

There are also documents that may be required for this process depending on the nature of the product, such as:

• Relatório de Informações Econômicas, a report on characteristics of the medical equipment like the price established in other territories, the number of potential patients it can serve, the intended price to be established in Brazil including taxes, details on the products cost for manufacturing and marketing and replacement products available in the Brazilian market - required for products such as pacemakers, surgical prosthesis and hearing aids

• Certificado de Conformidade INMETRO, a certificate issued by the National Institute of Metrology, Quality and Technology, and granted after a series of laboratorial tests to ensure the device’s compliance to Brazilian regulations and safety standards for electrical equipment - required only for active medical equipment, or those that use electricity as part of functioning, like electroencephalography devices and lung ventilators

The process can be initiated through the petitioning system on Anvisas’s website and provides costs to the company, depending on the type of petition required. Once the process has been successfully initiated, it must be filed by Anvisa’s headquarters in Brasilia. To this end, companies must send representatives to file the petition in person or establish contact with Anvisa by mail. All required documents must be filed by the company’s legal and technical supervisors.

Listing Process

The process to list medical equipment under Anvisa, required for most products in categories I and II, can be summarized in the issuance of a series of documents to the agency, starting with a petition requiring a new product, or product family, to be included on their database and proof of payment of Health Surveillance service taxes.

The product listing petition, found on Anvisa’s website, requires the following information to be submitted:

• General data about the equipments manufacturer or importer
• General data about the equipment, such as technical and commercial names and categories
• Product specifications, such as description of use, dimensions, sterilization methods, transport, storage conditions and precautions

Additionally, a declaration of the equipments compliance to the Brazilian Health Surveillance regulation signed by the company’s legal and technical supervisors must be included with the listing petition along with images of the equipment both printed and in digital format recorded on a CD. The equipment listing process, once approved by Anvisa, lasts for a maximum period of five years, after which companies must revalidate the equipment on the agency’s database in a process similar to the equipment listing.

Registration Process for categories I and II

Medical equipment in categories I and II that require registration with Anvisa must submit a series of documents as part of the registration petition, including:

• Detailed product description, along with user manual, tag and label models, both of which must display the products characteristics, risks for usage and storage conditions
• Proof of payment of Health Surveillance service tax
• Certificate of conformity, if required for the equipment
• Copy of proof of registry or Free Trade certificate from the equipments country of origin, along with a letter of consent allowing for the commercialization of the equipment in Brazil, required for imported class II products only
• Copy of Anvisa’s Boas Práticas de Fabricação e Controle Certificate
• Specific technical dossier required by Anvisa for equipment that makes use of new technologies

The product registration, once approved by Anvisa, also lasts for a maximum of five years, after which companies must revalidate in a process similar to the registration process.

Registration Process for categories III and IV

Medical equipment in categories III and IV are required to submit documents to Anvisa as part of the registration petition, all of which are in the Portuguese language. These are:

• Special form for identification of the product, manufacturer or importer
• Proof of payment of Health Surveillance service tax
• Copy of the company’s Autorização de Funcionamento da Empresa
• Product label
• Product user manual
• Product technical report
• Proof of compliance to Anvisa’s Technical regulation
• Copy of Anvisa’s Boas Práticas de Fabricação e Controle Certificate
• Copy of proof of registry or Free Trade certificate from the equipments country of origin, along with authorization for the equipment commercialization in Brazil, for imported products

In addition to presenting these documents in printed format, companies are also expected to send the product identification form, product label and user manual in digital format recorded on a CD. The equipment registration, once approved by Anvisa, lasts for a maximum period of five years, after which companies must revalidate the equipment in a process similar to the registration process.

Revalidation and additional regulation

Companies that intend to revalidate or register a change in the products specifications must initiate a process similar to the equipments listing or registering petitions, which involves issuing a number of the same documents containing the products characteristics and the company’s compliance to Anvisa’s regulation.

Additionally, the agency institutes that all marketing content related to registered products must contain information strictly tied to the specifications presented to Anvisa by the company, or the company can be subject to fines and other punishment measures.