Regulated sectors

An Operating Authorization (AFE) is required for companies carrying out activities such as manufacturing, importing, storing, distributing and transporting medicines and pharmaceutical ingredients for human use.

• RDC 16 — art. 3º (opens in a new tab)

A Special Authorization (AE) is required for activities involving substances, plants and fungi subject to special control, or medicines and products containing them, under the rules cited by Anvisa.

• RDC 16 — art. 4º (opens in a new tab)

Pharmacovigilance encompasses the science and activities of detecting, assessing, understanding and preventing adverse events and other medicine-related problems.

• RDC 406 — art. 3º, XIII (opens in a new tab)

The Federal Police controls and inspects chemicals that may be used as inputs in the production of narcotic, psychotropic or dependence-inducing substances.

• Law 10.357 — arts. 1º e 3º (opens in a new tab)

Medical devices in risk classes I and II are subject to notification; those in classes III and IV require registration.

• RDC 751 — arts. 6º e 7º (opens in a new tab)

Devices subject to certification under the Brazilian Conformity Assessment System (SBAC) may only be imported and marketed if manufactured while their Certificate of Conformity was valid.

• RDC 751 — art. 12 (opens in a new tab)

For medical devices, an Operating Authorization (AFE) is required for each establishment carrying out the activities specified in the regulation.

• RDC 16 — art. 3º, parágrafo único (opens in a new tab)

Good Manufacturing Practices set requirements for the manufacture of medical devices and in vitro diagnostic products.

• RDC 665 — art. 1º (opens in a new tab)

Technovigilance monitors adverse events and technical complaints involving medical devices after they reach the market.

• RDC 67 — art. 2º (opens in a new tab)

Personal hygiene products, cosmetics and perfumes are classified as Grade 1 or Grade 2.

• RDC 907 — art. 3º, XVII e XVIII (opens in a new tab)

The groups specified in the regulation, such as tanning products, antiseptic hand gels and hair straightening products, require registration. Other groups are exempt from registration and subject to prior communication to Anvisa.

• RDC 907 — arts. 34 e 35 (opens in a new tab)

Registration is valid for ten years. Products exempt from registration do not require renewal; consult the source for the conditions for maintaining their regulatory status.

• RDC 907 — arts. 40 e 41 (opens in a new tab)

A domestic manufacturer must hold an Anvisa Operating Authorization (AFE) to manufacture the product class it intends to regularize or manufacture.

• RDC 907 — art. 37 (opens in a new tab)

Depending on the category, food and packaging must undergo registration or notification with Anvisa, or communication of the start of manufacturing or importing to the state, Federal District or municipal health authority, before being offered on the market.

• RDC 843 — art. 3º (opens in a new tab)

Anvisa does not issue Operating Authorizations (AFE) to food-sector companies. Establishments must obtain prior licensing from the competent state, Federal District or municipal health authority.

• Anvisa: AFE and AE — Informações gerais, item 4 (opens in a new tab)

MAPA is responsible for the inspection and oversight of veterinary products and establishments carrying out the activities specified in the regulation.

• Decree 5.053 — Anexo, arts. 1º e 2º (opens in a new tab)

Sanitizing products are classified as risk 1, subject to notification, or risk 2, subject to registration.

• RDC 989 — art. 8º (opens in a new tab)

Sanitizing products are substances or preparations for cleaning and related purposes, antimicrobial action or pest control on surfaces, textiles, objects and environments, including products for disinfecting drinking water and swimming pool water.

• RDC 989 — art. 4º, XV (opens in a new tab)

An Operating Authorization (AFE) is required for companies carrying out activities such as manufacturing, importing, storing, distributing and transporting sanitizing products.

• RDC 16 — art. 3º (opens in a new tab)

The Federal Police is responsible for controlling and inspecting chemicals that may be used to produce narcotic, psychotropic or dependence-inducing substances.

• Law 10.357 — arts. 1º e 3º (opens in a new tab)

Activities such as storing, distributing, dispatching, importing and transporting products covered by the regulation are subject to an Operating Authorization (AFE). The applicable requirements depend on the product and activity.

• RDC 16 — art. 3º (opens in a new tab)