Registration validity
approval.registration-validity-years
- Years
10
- StartsFrom
official-gazette-publication
Conditions
- Applies to products on the registration route.
ANVISA · structured requirements
🇧🇷 Brazil medical device regulatory data
Explore the medical device requirements currently available for Brazil, organized by topic and linked to official sources.
13 facts7 dimensions3 official sourceslatest verification 2026-08-24
Approval validity & renewal
What expires, what is retained periodically, and when must renewal start?
Fact-level verified
Authorization duration
authorization.duration
- Type
Route Dependent
- Description
Class I/II notification is generally indefinite; Class III/IV registration is valid 10 years.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Expiry or lapse consequence
authorization.lapse
Expired registration cannot support new lawful placement; use the current renewal/new-registration rule.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Renewal or maintenance
authorization.renewal
Class III/IV renewal is filed from 12 to 6 months before expiry; notification devices remain subject to ongoing compliance.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Change control
Does the event require internal documentation, notice, prior approval, transfer, or a new application?
Change-control outcomes
change.available-outcomes
- Outcomes
- Notification Or Administrative Update
- Prior Approval Amendment Or Variation
- New Registration Or New Application
- Description
Renewal and change are separate transactions.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
New-application triggers
change.new-application-triggers
- changes outside permitted post-registration categories or creating a new device
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Post-approval changes
change.prior-authorization
The marketed product must correspond to the ANVISA-authorized product; changes require prior agency authorization.
Classification rules
What local class follows from which rules and decisive product facts?
Classes requiring registration
registration.required-classes
- Classes
- III
- IV
- Route
registration
Dossier requirements
Which evidence, local deltas, formats, and signatures are required?
Dossier checklist source
dossier.required-checklist
The mandatory document list is the checklist for the selected subject code.
Economic-operator roles
Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?
Local market-entry role
market-entry.local-role
- Archetype
Marketing Authorization Holder Or Registrant
- Name
Brazilian registration holder
- Required For Foreign
yes
- Registration Relation
Holds ANVISA Notification Or Registration
- Importer Relation
May Be Same Or Third Party With Holder Authorization
- Distributor Relation
May Be Separate
- Combination
allowed
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Representative or holder change
market-entry.representative-change
- Path Code
Holder Transfer Or Regulatory Change Route
- Fresh Registration
Route Dependent
- Minimum Handover
- manufacturer authorization
- holder transfer documents
- dossier and ANVISA history
- complaints/vigilance/recalls
- Portuguese labels
- DDR/import authorizations
- Notes
The holder and physical importer can differ; changing one does not automatically change the other.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Official forms & portals
Which current form, portal, account, and submission package must be used?
Primary petitioning system
submission.primary-system
ANVISA Sistema de Peticionamento
Registration pathways
Which registration, notification, listing, reliance, or conformity route applies?
Product or family registration
registration.grouping-options
- single-product
- product-family
Conditions
- Every model in a family must meet the applicable family criteria.
Keep researching this market
More Brazil medical device resources
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Need to apply Brazil's requirements to a product?
Confirm the current ANVISA pathway, evidence, and local-role details for the actual device before filing.