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Alterações & Revalidação
Changes, Variations, Revalidation & Lifecycle Support (Brazil)
Changes to a device after Brazilian regularization can affect the notification/registration, technical dossier, BGMP certification, labeling, UDI/SIUD data and post-market obligations. The correct action depends on the type and significance of the change and should be assessed before implementation whenever possible.
When This Support Is Needed
Design, raw material, or engineering specification changes are planned for a registered device
Manufacturing site relocation, line expansion, or critical component supplier is changing
Software algorithms, AI/ML models, firmware, or cybersecurity patches are being released
Sterilization method, packaging material, or validated shelf-life duration is changing
Intended clinical use, indications, packaging artwork, or performance claims are changing
A 5-year registration renewal / revalidation (revalidação de registro) deadline is approaching
What We Challenge Before Submission
Could the planned change alter the device risk classification or approved intended clinical use?
Does the existing pre-clinical test evidence still represent the modified device configuration?
Does the change require formal ANVISA approval (deferimento) prior to commercial implementation?
Do Brazilian public register records, packaging labels, or SIUD data need to be updated simultaneously?
Does a manufacturing site transfer affect the approved BGMP / CBPF certificate scope?
Our Lifecycle Change Management Scope
Regulatory change-impact assessment against RDC 751/2022, RDC 830/2023, and ANVISA guidance
Notification / registration change categorization (alteração de notificação / alteração de registro)
Technical dossier update strategy and verification/validation gap assessment
Risk-management file update and benefit-risk re-evaluation (ISO 14971)
Clinical and analytical performance evidence impact assessment
BGMP / CBPF certification impact assessment following site transfers or process changes
Legal manufacturer, manufacturing site, and certificate change petition support
Portuguese label and IFU revision review and harmonization
UDI change trigger analysis and SIUD database record updating
Revalidation planning, petition drafting, and submission prior to statutory deadlines
Transfer of registration ownership (transferência de titularidade) and cancellation strategy
Lifecycle Evaluation Rule:
We do not ask only whether the product changed. We ask whether the change affects the regulatory basis on which ANVISA accepted the device: classification, intended use, technical evidence, manufacturing controls, safety/performance or product identity.
Manage ANVISA Variations and Revalidation Filings
Our regulatory strategists assess change impact, structure alteração petitions in Solicita, and manage revalidação renewals.