Product Registration
From classification to filing: we define the product’s regulatory pathway (notification or registration, with ANVISA or MAPA) and prepare the dossier, for domestic and imported products.
- Company stage
- Enable
From classification to dossier.
The pathway depends on the product category and risk class. That is why classification comes before any document.
Classification
Category, risk class and technical grouping, which define the pathway and the competent authority.
- Category and risk
- Technical grouping
- Competent authority
Regulatory pathway
Notification or registration, according to the rule for each category.
- Medical devices: notification (classes I and II) or registration (III and IV)
- Cosmetics and sanitizers: notification or registration, by risk class
- Food: registration, notification or notice of start
Technical dossier
Guidance, review and preparation of the documentation that accompanies the application.
- Technical documentation
- Labelling and instructions for use
- Review before filing
Imported products
Authorization of products made abroad, working with the manufacturer to gather the documentation.
- Foreign manufacturer
- Local-language labels
- Import approval
Filing and follow-up
Filing, follow-up of the review and answers to technical requests until the decision.
- Filing
- Answers to requests
- Follow-up to decision
Foreign company?Explore the Market Entry path
Other services for this stage.
- Company LicensingEnableAFE and AE at ANVISA, establishment registration with MAPA, and licences from health surveillance authorities, the Federal Police, the Army, environmental agencies and municipalities.
- GMP CertificationsEnableAdaptation to Good Practices and preparation for the certification inspection.
- Compulsory Certification & Foreign MarketsEnableLiaison with certification bodies under the INMETRO and ANATEL schemes and in other compulsory certifications.
Common questions before you start.
What is the difference between notification and registration with ANVISA?
Notification is a simplified procedure applied to lower-risk products; registration is the full review of the dossier by ANVISA before the marketing authorization. They are the two product regulatory pathways, and the choice depends on the category and the risk level of each product.
Does an imported product follow the same pathway as a domestic one?
Yes: the pathway is defined by the product, not its origin. An imported product, however, requires additional documents, such as proof of the regulatory status and Good Practices of the foreign manufacturer, the Portuguese-language label and the import consent. For products subject to an AFE, the importer needs one for the product class.
What happens if a product is sold without regulatory approval?
Selling a product subject to health surveillance without the required authorization is a health infraction, subject to seizure and penalties. That is why the classification must be done before launch, including to define whether the product needs registration, notification or only a communication.
Last updated: October 2026.
Have a product to bring to market?
With the product’s category and origin, we indicate the regulatory pathway and what the dossier must contain.