ANVISA Guidance Manuals 2026: Medical Device & IVD Regularization, Notification, Submission & Compliance Guide

ANVISA Guidance Manuals for IVD Regularization, Class I–II Medical Device Notification, GMP, Company Authorization & Post-Market Regulatory Actions

Brazil's medical device market continues to attract global manufacturers seeking access to one of Latin America's largest healthcare markets. However, successful commercialization requires manufacturers, importers, and local representatives to understand ANVISA's regulatory classification, regularization, notification, documentation, GMP, company authorization, and post-market requirements.

On 25 August 2026, National Health Surveillance Agency (ANVISA) released new guidance manuals addressing the regulatory regularization of in vitro diagnostic (IVD) devices and the notification of Class I–II medical devices.

The manuals consolidate regulatory procedures and provide practical instructions for preparing petitions, submitting documentation, managing post-market changes, and avoiding inconsistencies that may result in requirements or rejection.

For manufacturers and Brazilian legal representatives, the updated manuals are particularly relevant because they clarify the regulatory pathway, documentation expectations, company authorization requirements, electronic submission process, and post-market petitioning activities.

Why ANVISA Medical Device Compliance Matters

Key compliance areas include:

• Product regulatory classification
• Regularization pathway
• Notification requirements
• Technical documentation
• Company authorization
• AFE requirements
• Local sanitary licensing
• Brazilian legal representation
• GMP compliance
• CBPF requirements
• Electronic petitioning
• Post-market changes
• Ownership transfers
• Cancellations
• Revalidation
• Regulatory lifecycle management

Failure to follow the applicable requirements can result in summary rejection, technical requirements, submission delays, additional regulatory work, market-entry delays, or difficulties maintaining the product's regulatory status.

ANVISA's New Guidance Manuals

The August 2026 update covers two important regulatory areas.

1. Manual for Regularization of In Vitro Diagnostic Devices

This manual addresses the regularization of IVD products under RDC 830/2023, including applicable registration and notification procedures and related post-market petitions.

2. Manual for Regularization of Materials for Health Use Subject to the Notification Regime

This manual addresses the notification of applicable Class I and Class II medical devices under RDC 751/2022.

Together, the manuals are intended to consolidate regulatory instructions and help manufacturers, importers, and Brazilian legal representatives submit more complete and consistent petitions.

Purpose of the ANVISA Manuals

The updated manuals are designed to provide greater clarity regarding:

• Applicable regulatory pathways
• Petition selection
• Required documentation
• Electronic submission
• Company requirements
• Technical information
• Post-market petitions
• Regulatory modifications
• Cancellation procedures
• Ownership transfers
• Revalidation requirements

The practical objective is to reduce incomplete submissions, inconsistencies, avoidable technical requirements, rework, and rejection.

IVD Regulatory Framework in Brazil

Companies placing IVD products on the Brazilian market should first establish the regulatory status of the product.

The process generally requires companies to:

Determine whether the product falls within the IVD regulatory framework.

1. Classify the IVD according to applicable rules.
2. Determine whether registration or notification applies.
3. Identify the correct petition.
4. Confirm company authorization requirements.
5. Prepare technical documentation.
6. Submit electronically through the applicable ANVISA system.
7. Monitor the petition.
8. Respond appropriately to regulatory requirements when applicable.
9. Maintain regulatory status throughout the product lifecycle.

Incorrect classification or selection of the wrong petition can create significant regulatory delays.

Class I–II Medical Device Notification

For applicable medical devices regulated under the notification regime, manufacturers and importers should confirm the product's classification and determine whether notification is appropriate under RDC 751/2022.

The notification pathway does not eliminate the manufacturer's responsibility for:

• Product safety
• Performance
• Technical documentation
• GMP compliance
• Traceability
• Post-market compliance
• Change management

Companies should therefore treat notification as a regulatory pathway rather than as an exemption from ongoing compliance obligations.

Company Authorization Requirements

Appropriate company authorization is a fundamental component of Brazilian medical-device compliance.

For IVD applicants, companies should assess requirements involving:

• Company registration
• AFE — Authorization for Operation
• Local sanitary license
• Brazilian legal representative
• Technical responsibility

Foreign manufacturers generally require an appropriately established Brazilian company to act as the local regulatory/legal representative and assume applicable technical and legal responsibilities.

Before initiating product regularization, companies should verify that the local entity has the required authorization and licensing status.

AFE and Local Sanitary Licensing

The Company Operating Authorization (AFE) is an important component of the Brazilian regulatory framework for companies conducting regulated activities.

Manufacturers, importers, and other regulated entities should ensure that their corporate authorization and sanitary licensing are appropriate for the activities they intend to perform.

Product submission should therefore not be considered independently from the company's regulatory status.

Company authorization + product regularization + technical compliance should be managed as an integrated regulatory strategy.

GMP and CBPF Requirements

Good Manufacturing Practices remain a significant requirement for medical devices and IVD products.

Applicable GMP requirements are established under RDC 665/2022.

For registerable IVD products, the Good Manufacturing Practices Certificate (CBPF) is required as applicable to the regulatory pathway.

For notified products, GMP obligations still apply even where CBPF documentation is not submitted as part of the notification.

This distinction is important because absence of a CBPF submission does not mean that GMP requirements do not apply.

Companies should maintain appropriate GMP systems, manufacturing controls, quality records, supplier controls, complaint procedures, and traceability mechanisms.

IVD Technical Documentation

A complete IVD submission should be supported by the documentation applicable to the product and regulatory pathway.

Companies should assess:

• Product description
• Intended purpose
• Classification
• Technical characteristics
• Performance information
• Manufacturing information
• Labelling
• Instructions for use
• Risk-related information
• Quality documentation
• Applicable certificates
• Company authorization documents

The regulatory dossier should be internally consistent across technical, administrative, manufacturing, and labelling information.

IVD Submission Completeness

One of the important practical considerations emphasized by the updated guidance is the importance of submission completeness at the initial filing stage.

Where required technical documentation is missing, the petition may be subject to summary rejection rather than a subsequent technical requirement process.

This makes pre-submission document verification particularly important.

Companies should therefore conduct a structured completeness check before electronic filing.

Recommended Pre-Submission Check

Classification → Petition type → Company authorization → Technical documents → Labelling → GMP/CBPF status → Administrative documents → Electronic submission

This approach can reduce avoidable deficiencies and rework.

SOLICITA Electronic Petitioning

Applicable ANVISA regulatory petitions are submitted electronically through the agency's systems, including SOLICITA, for relevant procedures.

Companies should:

• Identify the correct service
• Select the appropriate petition
• Complete required information
• Upload supporting documentation
• Review data consistency
• Submitting electronically
• Monitor petition status
• Manage regulatory communications

Incorrect service selection or incomplete documentation can undermine an otherwise technically strong submission.

Post-Market Regulatory Petitions

The new manuals also address important lifecycle activities after initial regularization.

Applicable post-market activities may include:

• Changes and amendments
• Additions
• Cancellations
• Transfer of ownership
• Revalidation
• Other regulatory updates

The IVD manual additionally addresses revalidation and other post-registration procedures.

Companies should establish formal change-control procedures so that regulatory consequences are assessed before implementing commercial or manufacturing changes.

IVD Registration Validity

For applicable registered IVD products, registration is generally valid for 10 years.

Companies should plan revalidation within the applicable regulatory window.

Revalidation should be filed between 6 and 12 months before the registration expires.

A regulatory calendar should therefore include:

• Registration approval date
• Expiry date
• Revalidation filing window
• Required supporting documents
• Post-market changes
• Manufacturer changes
• Ownership changes

Early preparation reduces the risk of interruption to regulatory status.

Notification Validity

Unlike registered products, applicable notified medical devices have indefinite validity and are not subject to periodic revalidation.

However, indefinite validity does not eliminate lifecycle responsibilities.

Companies should continue monitoring:

• Product changes
• Manufacturing changes
• Legal representative changes
• Labelling
• Regulatory requirements
• GMP compliance
• Post-market safety
• Traceability

Regulatory Classification

Correct classification remains one of the most important steps in Brazilian market access.

Companies should assess:

• Intended purpose
• Risk classification
• Technology
• Mode of action
• Duration of use
• Target population
• Clinical application
• IVD-specific characteristics

Incorrect classification can result in the selection of an inappropriate regulatory pathway and may contribute to rejection or significant rework.

Labelling and Technical Consistency

Product labelling should remain consistent with the regulatory documentation submitted to ANVISA.

Companies should verify:

• Product name
• Intended purpose
• Manufacturer
• Brazilian legal representative
• Instructions for use
• Warnings
• Technical information
• Identification information
• Applicable regulatory information

Any change to commercial artwork should undergo regulatory assessment before implementation.

ANVISA 2026 Regulatory Readiness Assessment

ANVISA Medical Device Compliance Roadmap

Common ANVISA Compliance Challenges

Companies commonly face:

• Incorrect product classification
• Wrong petition selection
• Incomplete technical documentation
• Inconsistent product information
• Missing company authorization
• Inadequate local representation
• GMP documentation gaps
• CBPF misunderstandings
• Labelling inconsistencies
• Incorrect electronic submissions
• Failure to manage post-market changes
• Missed IVD revalidation timelines
• Weak regulatory change control

Best Practices & Common Mistakes

Organizations should determine regulatory status early, confirm classification, establish the correct Brazilian legal representative, verify AFE and sanitary licensing, prepare complete technical documentation, assess GMP and CBPF requirements, conduct a petition-level completeness review, verify labelling consistency, and establish lifecycle change-control procedures.

Avoid submitting incomplete technical dossiers, selecting an incorrect petition, assuming notification eliminates GMP obligations, overlooking company authorization requirements, implementing changes without regulatory assessment, or waiting until registration expiry to begin revalidation preparation.

Business Benefits of ANVISA Regulatory Readiness

Future Trends

Brazil's medical-device regulatory environment is likely to continue emphasizing:

• Digital regulatory submissions
• Regulatory standardization
• Risk-based classification
• Technical-document completeness
• GMP compliance
• Lifecycle management
• Post-market surveillance
• Electronic regulatory processes
• Product traceability
• Regulatory transparency

The August 2026 manuals demonstrate ANVISA's continuing effort to consolidate practical regulatory instructions and improve the consistency of medical-device and IVD submissions.

Frequently Asked Questions

1. What did ANVISA release on August 25, 2026?

ANVISA released new guidance manuals covering IVD regularization and the notification of applicable Class I–II medical devices.

2. Which regulation applies to IVD regularization?

The IVD pathway is addressed under RDC 830/2023.

3. Which regulation applies to Class I–II medical-device notification?

The notification framework is addressed under RDC 751/2022.

4. What is the purpose of the new manuals?

They consolidate regulatory instructions to help manufacturers, importers, and legal representatives prepare more complete and consistent petitions and reduce avoidable rework, requirements, and rejection.

5. Are post-market activities covered?

Yes. The manuals address applicable amendments, additions, cancellations, ownership transfers, and other lifecycle procedures. The IVD manual also covers revalidation and additional post-registration activities.

6. Is CBPF required for all products?

Requirements depend on the regulatory pathway. For registerable IVDs, applicable CBPF requirements apply. Notified products remain subject to GMP requirements even where CBPF is not submitted.

7. What happens if an IVD submission is incomplete?

Missing required technical documentation at initial filing can result in summary rejection, rather than necessarily generating a technical requirement.

8. How long is IVD registration valid?

Applicable IVD registration is generally valid for 10 years.

9. When should IVD revalidation be submitted?

Revalidation should be planned within the applicable 6–12-month period before expiry.

10. Do notified medical devices require revalidation?

Applicable notified products have indefinite validity and are not subject to periodic revalidation.

11. Do foreign manufacturers need a Brazilian company?

Foreign manufacturers generally need an appropriately established Brazilian legal representative to undertake applicable local technical and legal responsibilities.

12. What is SOLICITA?

SOLICITA is an electronic platform used for applicable ANVISA regulatory petitioning and submission procedures.

13. Does notification mean GMP is not required?

No. Products subject to notification remain subject to applicable GMP obligations even where CBPF is not submitted.

14. How should companies prepare for the new guidance?

Begin with classification, regulatory-status assessment, company authorization, petition selection, technical-document review, GMP/CBPF assessment, labelling verification, electronic submission, and lifecycle change control.

15. How can Maven Regulatory Solutions help?

Maven Regulatory Solutions can support ANVISA regulatory strategy, medical-device and IVD classification, RDC 830/2023 and RDC 751/2022 pathway assessment, technical documentation review, AFE and local-representative assessment, GMP/CBPF strategy, submission readiness, post-market changes, revalidation planning, regulatory gap assessments, and Brazil market-entry strategy.

Conclusion

ANVISA's 25 August 2026 guidance manuals provide an important practical reference for companies seeking to regularize IVDs and notify applicable Class I–II medical devices in Brazil.

The updated approach reinforces the importance of correct classification, appropriate petition selection, complete technical documentation, company authorization, Brazilian legal representation, GMP compliance, electronic submission, and lifecycle management.

For IVD manufacturers, particular attention should be given to registration validity, the 6–12-month revalidation window, CBPF requirements, and the consequences of incomplete initial submissions.

For notified medical devices, companies should understand that indefinite validity does not remove ongoing GMP, quality, post-market, and change-control responsibilities.

By integrating regulatory strategy into product development and commercialization, manufacturers can reduce avoidable submission problems, improve dossier quality, strengthen ANVISA readiness, and establish a more efficient pathway to the Brazilian medical-device market.

Why Choose Maven Regulatory Solutions?

Maven Regulatory Solutions supports medical-device and IVD companies with ANVISA regulatory strategy, product classification, Brazil market-entry assessment, RDC 830/2023 and RDC 751/2022 compliance, technical dossier review, notification and registration strategy, AFE/CBPF assessment, regulatory submission support, labelling review, post-market change management, revalidation planning, regulatory gap assessments, and lifecycle compliance.

Our Brazil-focused regulatory approach helps global manufacturers and local representatives develop efficient, compliant, and submission-ready strategies for entering and maintaining medical-device and IVD products in the Brazilian market.