What is the purpose of RDC 40/2015?

RDC 40/2015 establishes simplified notification requirements for Class I-II medical devices, replacing the full registration process with automatic 30-day approval to reduce regulatory burden while maintaining safety oversight for low and moderate-risk devices.

Which devices qualify for notification?

Class I and II medical devices qualify for notification under RDC 40/2015. This includes non-invasive diagnostic devices, surgical instruments, examination gloves, contact lenses, dressings, and other low to moderate-risk products. Class III-IV devices require full registration instead.

How does notification differ from registration?

Notification provides automatic approval in 30 days with simplified documentation for Class I-II devices. Registration requires extensive technical evaluation, clinical data review, GMP certification verification, and 6-12 month approval timeline for Class III-IV devices with higher regulatory scrutiny.

What is the step-by-step notification process?

Notification process: 1) Prepare required documentation and Portuguese labeling, 2) Submit through ANVISA online portal with fees, 3) ANVISA completeness review (30 days), 4) Automatic approval if no objections, 5) Receive notification number for market authorization. Total timeline: 30 days.

What happens if ANVISA requests additional information?

If ANVISA identifies incomplete documentation or compliance concerns during 30-day review, they issue exigência técnica (technical request) specifying required information. Manufacturer must respond within deadline (typically 60 days) or notification will be denied. Timeline extends until response.

Can notification be expedited or fast-tracked?

No formal expedited pathway exists for notifications. The 30-day timeline is fixed by regulation. However, submitting complete, well-organized documentation with accurate Portuguese translations minimizes likelihood of technical requests, ensuring automatic approval at 30-day mark without delays.

What technical report information is required?

Technical report must include: device commercial name and model, manufacturer details, intended use and indications, risk classification with justification, device description (materials, components, operating principle), technical specifications, contraindications and warnings, and conformity to essential safety requirements.

What GMP documentation is required?

Notification requires GMP declaration or certificate showing manufacturer compliance with quality standards. Acceptable documents include: MDSAP certificate, ISO 13485 certificate, FDA establishment registration, Health Canada MDL, TGA license, or manufacturer's declaration of GMP compliance per RDC 665/2022.

What is the conformity declaration requirement?

Manufacturers must declare device conformity to essential safety and performance requirements per RDC 56/2001. Declaration should reference applicable standards used for compliance (IEC, ISO), describe how each essential requirement is met, and be signed by manufacturer's authorized representative.

What information must appear on device labeling?

Labeling must include in Portuguese: device name, manufacturer name and address, Brazilian legal representative details, notification number (after approval), manufacturing and expiration dates, lot/serial number, intended use, storage conditions, warnings, and applicable symbols per RDC 185/2001.

What must be included in Instructions for Use?

Instructions for Use (IFU) must be in Portuguese and include: device description and intended use, contraindications and warnings, step-by-step operating instructions, cleaning/maintenance procedures, technical specifications, manufacturer and legal representative details, notification number, and adverse event reporting information.

What is the exact timeline for notification approval?

Standard notification timeline is exactly 30 calendar days from submission. If ANVISA does not issue technical request or objection within 30 days, device automatically receives market authorization. Timeline extends if ANVISA requests additional information, with total process ranging 30-90+ days.

What happens after notification approval?

After approval, manufacturers receive notification number, device is published in official gazette (Diário Oficial da União), labeling must be updated with notification number, importation can begin through customs clearance, distribution to market starts, and post-market surveillance obligations become active.

RDC 40/2015 FAQ - Updated October 2025

Brazil Medical Device Notification Requirements. Expert guidance by Pure Global regulatory specialists

Notification Process

Class I-II

30-Day Timeline

Automatic Approval

Official Document

Access the official document:Download RDC 40/2015 (Portuguese document)

Navigate Brazil's Notification Process with Pure Global

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Pure Global offers comprehensive notification support for Class I-II medical device manufacturers, streamlining documentation preparation, classification justification, labeling compliance, and ANVISA submission to achieve automatic approval within 30 days under RDC 40/2015.

Classification Support

Risk classification determination and justification per ANVISA rules

Documentation Preparation

Technical reports, labeling, IFU translation and compliance verification

Submission Management

ANVISA portal submission and automatic approval tracking

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Scope

Class I-II

Low and moderate-risk devices

Process

Notification

Simplified vs. full registration

Timeline

30 days

Automatic approval period

Authority

Automatic

No explicit approval required

Frequently Asked Questions

On This Page

General Notification Requirements

Class I & II Device Notification Process

Documentation Requirements

Labeling & IFU Requirements

Timeline & Approval Process

Quick Resources

All Brazil Regulations How to Choose a Brazil Registration Holder Free Brazil Medical Device Classifier Brazil Medical Device Database Brazil Market Insights & Analytics Classification Game Pure Global Brazil Services

Key Dates & Milestones

PublishedAugust 26, 2015

Effective DateOctober 25, 2015

ReplacedPrevious registration requirements for Class I-II

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Note: This FAQ guide provides general information about regulatory requirements and should not be considered as legal advice. Regulations are subject to change. Always consult with qualified regulatory professionals for specific guidance.

Last updated: October 2025 | Based on RDC 40/2015 official documentation