Classification and pathway
For general medical devices, Classes I and II generally follow notification and Classes III and IV registration. Confirm requirements against intended purpose and device characteristics; assess IVD rules separately.
BR · ANVISA
Brazil ANVISA registration
Plan risk classification, a local registration holder, technical documentation and applicable supporting certifications as coordinated but distinct workstreams.
How SUNGO supports your project
Brazilian registration holder
Coordinate a Brazilian registration holder (BRH) and authorisation arrangements. Clarify manufacturer, holder and importer responsibilities and administrative-document requirements.
Technical and Portuguese documentation
Organise models, materials, performance, risk management and applicable biological and sterilisation evidence. Support Portuguese labelling, instructions and responses to review questions.
Related certifications and maintenance
Assess applicable INMETRO, wireless-related ANATEL and GMP/BGMP requirements and coordinate relevant organisations. Support subsequent changes and registration maintenance.
Being an active device does not by itself determine every certification requirement. Overseas reports are not automatically accepted. Notification, registration, quality-system and supporting-certification requirements need separate assessment.
AFTER THE INITIAL DISCUSSION
Build a product-specific document plan
You do not need every document for the first enquiry. We identify gaps after understanding your product and target market.
Product name, purpose, materials and model range
Quality-system evidence and existing market authorisations
Test reports, labels and instructions
Local-holder arrangements and electrical, wireless or sterile features
Specific requirements are subject to product assessment and the competent authority’s current regulations.
Service process overview
- 01
Confirm classification and pathway
- 02
Prepare the documents
- 03
Submit the application
- 04
Respond to review enquiries
- 05
Complete the applicable procedures
Specific requirements are subject to product assessment and the competent authority’s current regulations.
INITIAL CONSULTATION
Start with two things
Send your product name and instructions for use, and tell Serena which market you are considering.
- Product name
- Instructions for use