Who it’s for
Who should attend
Regulatory affairs staff preparing ANVISA submissions, Brazil Registration Holders, quality managers responsible for B-GMP compliance and inspections, and manufacturers entering the Brazilian market.
Curriculum
Course modules
- ANVISA and the Brazilian regulatory framework
- RDC 751/2022: scope, definitions and the 22 risk classification rules aligned to IMDRF
- Notificação (Classes I and II) versus Registro (Classes III and IV)
- Technical dossier per Annex II of RDC 751/2022 and the IMDRF Table of Contents format
- Labelling and instructions for use: Portuguese language requirements, symbols, electronic IFU
- RDC 665/2022: Brazilian Good Manufacturing Practices (B-GMP) and quality system requirements
- B-GMP certification, ANVISA inspections and acceptance of MDSAP audit reports
- RDC 591/2021: Brazilian UDI system
- RDC 848/2024: amendments and clarifications to RDC 751/2022
- IN 290/2024: reliance-based review pathway using recognised foreign authority assessments
- RDC 657/2022: Software as a Medical Device
- Brazil Registration Holder role, alterations, revalidation and cancellation
Outcomes
What you’ll be able to do
- Classify a device under RDC 751/2022 and identify the registration pathway
- Assemble a compliant technical dossier
- Understand the B-GMP certification route and where MDSAP can be used
How it works
Delivery, group size and what’s included
Delivery formats
On-site at your premises, live remote, or public open course.
Duration
The durations shown are minimums. Most courses run from 2 to 5 days, and longer or combined programmes can be arranged to suit the course and your requirements.
Group size
No minimum for remote or private on-site training. Public courses run with a minimum of 10 attendees. There is no fixed maximum; above 20 we normally split into groups, though this is open to discussion.
Assessment
Courses include an assessment.
Tailoring
Private training can be tailored to your products and your quality system. Where a course is tailored, specific documents may be requested in advance. Public courses are general in scope, though relevant worked examples are provided.
Languages
English and Italian. German and Russian available on request through an associate.
Included in the fee
- Full course slides (PDF)
- Workshops
- Practical exercises
- Case studies
- Open Q&A throughout
- Certificate of attendance (PDF), issued by ALPA Medical
- Up to 4 hours of post-course support
Get in touch
Enquire about “Brazilian Medical Devices Regulatory Requirements”
Ask about dates, on-site or remote delivery, group size, or tailoring this course to your products and quality system.