Medical Device Registration in LATAM with AI Support
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Course description
An advanced HSC Academy course comparing medical device regulations in five Latin American countries (Mexico, Argentina, Colombia, Peru and Chile), using Brazil (ANVISA, RDC 751/2022) as the benchmark. Across 7 modules, the course covers authorities and legal frameworks, comparative classification, registration holding and local representation, reliance pathways and the use of foreign evidence (ANVISA, MDSAP and FDA), and harmonisation through IMDRF (N9 and N47), MERCOSUR Technical Regulations and MDSAP. The course also covers the use of generative AI in Regulatory Affairs within the QMS (ISO 13485): governance, tool validation, traceability, hallucination control and human review. Every requirement presented includes the standard and article, and every AI output is audited against the standard. A continuous case study runs through all 7 modules: medical electrical equipment with embedded software, ANVISA Class III, with an MDSAP certificate and FDA approval. Format: live online, 10 sessions of 4 hours (40h).
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Course objective
By the end of the course, participants will be able to: - Analyse the regulatory categorisation and class of the same device in Brazil and the five countries, citing the standard and article. - Compare processes, registration holding, validity, timelines and QMS requirements across jurisdictions. - Assess eligibility for reliance pathways and the use of evidence (ANVISA, MDSAP, FDA) in each country. - Understand the IMDRF harmonised dossier structure (N9 and Essential Principles N47) and its relationship with national requirements. - Apply governance, validation and human review criteria to the use of AI in Regulatory Affairs under ISO 13485 (Clause 4.1.6). - Plan the multi-country submission sequence, considering the schedule and documentary dependencies.
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Course programme
- 01
M1 Initial map: pathway, likely class and registration holder in each country; verification against the Chilean list (Exempt Decree 25/2026)
- 02
M2 Complete country-by-country product comparison matrix
- 03
M3 Core dossier in IMDRF N9 format, N47 matrix and consistency report
- 04
M4 AI use policy applied to the project and traceability record
- 05
M5 Five agents specified for the project
- 06
M6 Reasoned tool selection
- 07
M7 Submission plan with sequence, schedule, dependencies and checklist
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Who can attend?
- Regulatory Affairs and Quality professionals already working on ANVISA medical device regulatory compliance.
- Prerequisites:
- - Practical experience with notification and registration under RDC 751/2022.
- - Knowledge of Good Manufacturing Practice (RDC 665/2022), ISO 13485 and ISO 14971.
- - Technical reading skills in Spanish.
- - Access to a generative AI tool for practical exercises.
- The course does not review basic Brazilian regulations, which are used as the comparison reference throughout all modules.
Certification
HSC Global Certificate
Instructor
Flavia Alencar de Reis
Pharmacist with an MBA in Regulatory Affairs and Exemplar Global certification in FDA medical device registration. Nearly a decade working with Class I to IV dossiers, medical device vigilance and ANVISA inspections, as well as Latin American market access.
Flávia Alencar graduated in Pharmacy from Universidade Santa Cecília and holds an MBA and a specialisation in Regulatory Affairs from IPOG. She has worked in regulatory affairs and quality management in the healthcare sector for nearly a decade, with experience preparing and maintaining national and international Class I to IV medical device registration dossiers, amendments and post-registration activities, medical device vigilance, GMP certification (CBPF) and conducting ANVISA inspections.
In Latin America, she leads market access strategies and registration processes with regional health authorities, supporting manufacturers entering and expanding their products across multiple countries, work that led her to represent HSC Global at Meditech 2026 in Bogotá.
Certified by Exemplar Global as an FDA Medical Device Registration Specialist, she manages submissions to the US agency and works on quality management system certification under ISO 13485 and the MDSAP programme. At HSC Global, she is responsible for FDA submissions and training, and teaches the FDA Registration Specialist programme. Fluent in English and Spanish.