Frequently asked questions

Grupo Soluto brings together four specialized companies, from regulatory strategy to market access.

They cover regulatory strategy, registration holding, technology and market access.

There are four: Soluto Regulatórios, Ávita Care, Pixoom and Évira Pharma.

Soluto Regulatórios handles regulatory strategy; Ávita Care, registration holding and compliance; Pixoom, technology and automation; and Évira Pharma, market access.

Évira Pharma selects, qualifies and registers products and takes them through to distribution.

Contact the group’s single channel, which receives your request and directs it to the right company.

The group’s contact details are contato@gruposoluto.com.br and +55 19 3826-6800.

In Vinhedo, in the interior of São Paulo state: Rua Arnaldo Roque Brisque, 174, Vista Alegre, postal code 13285-328.

Soluto Regulatórios began operating in 2008.

The group developed around that foundation.

Gisele Pimenta, chief executive officer (CEO) and founder.

Submit it by email to the talent pool, which is used for future recruitment processes.

The address belongs to Soluto’s HR team: rh@gruposoluto.com.br.

The talent pool is for Soluto Regulatórios.

On LinkedIn (linkedin.com/company/gruposoluto) and Instagram (instagram.com/gruposoluto).

Not directly: regularization is handled by a company established in Brazil.

Limit of this statement: No single article prohibits direct registration; this answer synthesizes the cited rules and Anvisa guidance.

Anvisa states that only companies legally established in Brazilian territory may apply for an Operating Authorization.

A foreign company must have a commercial agreement with a company in Brazil; that company may act solely as an importer, assuming technical and legal responsibility.

A notification or registration application includes a declaration from the legal manufacturer authorizing the applicant company to represent it in Brazil.

It is the legal entity, manufacturer or importer responsible for the medical device in Brazil that holds the authorization to market it issued by Anvisa.

For health products, the registration holder is legally responsible for the product and answers to the health authorities for technical complaints or adverse events.

For medicines, the pharmacovigilance regulation uses the term “Medicine Registration Holder”.

“MAH” (Marketing Authorization Holder) is the international expression used by Ávita Care; it is not a term in the Brazilian regulation.

It depends on its risk class: classes I and II require notification; classes III and IV require registration.

The classes are I (low risk), II (medium risk), III (high risk) and IV (maximum risk).

A medical device registration is valid for 10 years and may be renewed for equal periods.

By applying the classification rules in RDC 751.

If the result is in doubt, Anvisa determines the classification.

It is the act by which Anvisa authorizes companies or establishments to operate, granted upon compliance with the regulation’s technical and administrative requirements.

It is required for each company that manufactures, imports, stores, distributes or transports medicines, pharmaceutical inputs, cosmetics, hygiene products, perfumes and sanitizing products; for health products, it is required for each establishment.

Special Authorization (AE) covers substances, plants and fungi subject to special control.

No: they are separate requirements. An AFE authorizes the company; registration or notification regularizes the product.

Limit of this statement: Article 12 applies to the products covered by Law 6.360. Products subject to notification or communication follow the rules of their respective regulation.

Under Law 6.360, the products it covers, including imports, may not be manufactured, offered for sale or supplied for consumption before being registered with the Ministry of Health.

Anvisa explains that an AFE and a local sanitary license are the starting point for applying for product registration or listing.

No: Anvisa does not issue AFEs for companies in the food sector.

The establishment is licensed by the state, Federal District or municipal health authority.

The product is regularized through registration, notification or communication of the start of manufacturing or importation, depending on its category.

Only certain groups: those listed in article 34 of RDC 907 require registration; the others are exempt from registration and undergo prior communication to Anvisa.

Groups requiring registration include tanning products, antiseptic hand gel, hair straightening products, sunscreens and repellents.

Products are classified as Grade 1 or Grade 2.

A domestic manufacturer must hold an Anvisa Operating Authorization for the product class.

By risk: risk 1 requires notification and risk 2 requires registration.

A sanitizing product is a substance or preparation for cleaning and related purposes, antimicrobial action and pest control on inanimate surfaces, textiles, objects and environments.

It is a document issued by Anvisa certifying that an establishment meets the technical Good Manufacturing Practices requirements needed to market the product.

The applicant must be a legal entity legally established in Brazil, and the regulation applies to manufacturers in Brazil and abroad.

Anvisa’s CBPF frequently asked questions page is the source for the application process.

Only if it requests an extension of its authorized activities: an importer bringing products in for sale must request authorization to distribute.

Anvisa import licenses are requested by companies registered with Anvisa and authorized to use Siscomex.