Medical Device Registration in LATAM with AI Support
From the ANVISA dossier to registration in Mexico, Argentina, Colombia, Peru and Chile. A regulation and article behind every decision, with AI applied at every stage and governance within the QMS.
BrazilANVISA, the course's reference point
MexicoCOFEPRIS
ArgentinaANMAT
ColombiaINVIMA
PeruDIGEMID
ChileISPThe same product follows six different sets of rules
Professionals already registering products with ANVISA discover that, outside Brazil, classifications change, holders change and seemingly obvious shortcuts do not always exist. Getting any of these wrong leads to regulatory requests, rework and months of delay.
Classification is not the same
Mexico uses three classes, Colombia uses I, IIa, IIb and III, and Chile only requires registration for products brought under control by a decree.
The holder changes from country to country
Legal representatives, authorised establishments, importers with their own certification: each agency requires a different local company.
Shortcuts only where the law permits
Reliance, recognition and use of existing evidence are not synonymous. Knowing where ANVISA registration opens doors changes the entire sequence.
For those who already know ANVISA and need to take a product to the region
The course does not repeat Brazilian regulatory basics. They are the reference point for comparison throughout all modules.
- Regulatory Affairs and Quality professionals with experience in notification and registration under RDC 751/2022
- Manufacturers and importers seeking to expand their portfolio from Brazil into Latin America
- Consultants serving clients with a multi-country strategy
- Teams seeking to use AI in regulatory processes with control, traceability and human review
From classification to a submission plan, with the regulation to hand
Classify in six countries
Regulatory assessment and classification of the same device, with a regulation and article behind every decision.
Choose the right pathway
Where reliance applies, where overseas evidence helps and where full registration is required.
Build a core dossier
A harmonised IMDRF structure with national modules for each agency.
Use AI with governance
An AI usage policy within the QMS, tool validation and mandatory human review.
Create AI agents
Specialist agents for registration stages, each with defined limits and review points.
Plan the submission
Country sequence, schedule and documentary dependencies in an actionable plan.
A real product, from the first map to the submission plan
Medical electrical equipment with embedded software, ANVISA Class III, with MDSAP certification and FDA approval. Each module adds a layer to the same project, and in the final session you present the complete plan for all five countries.
AI proposes. The professional verifies.
No regulatory statement enters the dossier without a person checking the regulation and article. Learn to use AI to gain speed without losing traceability.
Seven modules, 40 hours
Live, with practical work in every module
Live online classes
40 instructor-led hours, with room for questions about your portfolio.
Recordings for 120 days
Revisit any session after the cohort finishes.
Materials for 1 year
Workbooks, reference standards and exercises included.
HSC Academy Certificate
With 75% attendance and a minimum mark of 70%.
Course fee
Pre-sale12 instalments of R$233.33interest-free
or R$2,500.00 paid in full via Pix
I want to enrolEnquire about the next cohort
Speak to our team to confirm dates and times.
The regulations you will use, country by country
Every class works with the official text to hand. Versions were checked in September 2026, including recent changes in Mexico, Argentina and Chile.
Brazil
Brazil
- RDC 751/2022
- RDC 665/2022
- RDC 848/2024
- RDC 591/2021 and IN 426/2026 (UDI)
- RDC 67/2009 (medical device vigilance)
- RDC 551/2021 (field actions)
Mexico
Mexico
- Reglamento de Insumos para la Salud, with the 2021 and 2026 amendments
- Abbreviated regulatory pathway Lineamientos (DOF 18 July 2025)
- NOM-241-SSA1-2025 (GMP)
- NOM-137-SSA1-2025 (labelling)
- NOM-240-SSA1-2012 (medical device vigilance)
- COFEPRIS guidance on registration, changes and the abbreviated pathway
Argentina
Argentina
- Disp. 64/2025 (MERCOSUR Technical Regulation, Res. GMC 25/21)
- Disp. 9688/2019
- Disp. 4446/2025
- Disp. 8194/2023 (medical device vigilance)
- Disp. 5461/2026 (fees)
- Res. GMC 07/24 (Disp. 11467/2024)
Colombia
Colombia
- Decree 4725/2005
- Decree 582/2017
- Resolución 4816/2008 (medical device vigilance)
- Draft medical device health regulatory framework (MinSalud, under discussion)
Peru
Peru
- DS 016-2011-SA and amendments from 2012, 2013, 2015 and 2017
- DS 003-2020-SA (classification and essential principles)
- NTS 123-MINSA/DIGEMID (medical device vigilance)
- RD 101-2019-DIGEMID
Chile
Chile
- DS 825/1998
- Decreto Exento 25/2026
- Decree 41/2022
- Guía del Sistema Nacional de Tecnovigilancia (ISP)
Harmonisation
Harmonisation
- IMDRF N47, Essential Principles (Ed. 2)
- IMDRF N9, dossier structure (Ed. 4)
- MERCOSUR Medical Device Technical Regulation
- MDSAP Programme
QMS and technical standards
QMS and technical standards
- ISO 13485
- ISO 14971
- IEC 62304
- IEC 62366-1
- ISO 10993-1:2025
AI and data protection
AI and data protection
- ISO/IEC 42001:2023
- GAMP 5, 2nd edition (conceptual reference)
- LGPD and data protection laws in Mexico, Argentina, Colombia and Chile
Before you enrol
Bring your next registration to Latin America with a method
Speak to the HSC Academy team and secure your place in the next cohort.
I want to enrol