Medical Devices
Materials, equipment and other medical devices: from risk classification to post-registration management, for manufacturers and importers.
- Regulators
- ANVISA, INMETRO
Medical device fronts.
At ANVISA, the device’s risk class sets the pathway: notification for classes I and II, registration for classes III and IV.
Classification and pathway
Classification of the device under the rules and definition of the regulatory pathway.
- Risk classes I to IV
- Notification or registration
- Product grouping
Product authorization
Dossier, labelling and instructions for use, filing and follow-up with ANVISA.
- Technical dossier
- Labelling and instructions for use
- Filing and agency requests
INMETRO certification
Equipment under health surveillance needs an INMETRO certificate of conformity, kept valid throughout the registration or notification.
- Liaison with the certification body
- Certificate maintenance
Company and Good Practices
AFE, health licences and management of Good Practice certifications.
- AFE
- Health licence
- Good Practices
Post-registration and technovigilance
Changes, revalidations and technovigilance management once the product is on the market.
- Changes and revalidations
- Technovigilance
Imports and exports
Regulatory support for device import and export operations.
- Import approval
- Notification or registration certificate
Planning
Regulatory planning for start-ups, mergers, acquisitions and other corporate moves, with the transfer of ownership of registrations and notifications.
- Mergers and acquisitions
- Ownership transfer
Foreign company?Explore the Market Entry path
Common questions before you start.
How do I find the risk class of a medical device?
ANVISA classifies devices into four risk classes: I (low), II (medium), III (high) and IV (maximum), according to classification rules. Classes I and II follow notification; III and IV, registration. Classification is the first step of the work.
How long is a medical device registration valid?
Ten years, renewable for equal periods, with renewal requested between twelve and six months before expiry. A notification has no expiry date and needs no renewal.
Can a foreign company register devices in Brazil?
Not directly. The foreign manufacturer needs a company legally established in Brazil as the holder of the registration or notification, responsible for the imported and distributed product. For Classes III and IV, the manufacturing site needs a valid CBPF.
Last updated: October 2026.
A medical device to authorize?
With the description and intended use, we indicate the likely risk class and the ANVISA pathway.