LATAM MEDICAL DEVICES STRATEGY PLAYBOOK: Freyr’s Regulatory Strategy & Solutions to Drive Your Medical Devices Success in LATAM

Mandy Zhao is the Head of Business Growth for Greater China at Freyr, where she leverages over 10+ years of experience in the life sciences industry. With a deep understanding of global Regulatory frameworks and market access strategies, Mandy has played a pivotal role in supporting  Chinese medical device manufacturers through successful expansions into international markets. At Freyr, she has been instrumental in fostering strong partnerships and delivering customized solutions to address the unique challenges faced by companies entering highly regulated regions.

With over 20 years of experience in the pharmaceutical and consumer goods sectors across Latin America, Mario has led multicultural teams and Regulatory strategies for global companies such as Pfizer, The Coca-Cola Company, and Unilever.

His career has been focused on strategic Regulatory affairs management, mergers and acquisitions, technical transfers, and compliance in LATAM markets. He has held regional leadership positions across the region, offering a comprehensive perspective of the Latin American Regulatory landscape.

Mario holds a degree in Pharmacy and a Master's in Business Administration and is recognized for his pragmatic approach, collaborative leadership, and strong results orientation. He is a trusted voice in implementing efficient operational models, particularly in business transformation contexts.

Viviane is a Regulatory Affairs professional with over 20 years of experience leading Regulatory strategies in the medical devices, pharmaceuticals, biologics, Cosmetics, and food supplement sectors, both locally and internationally.

With a proven track record in managing complex Regulatory environments, Viviane brings deep expertise in product classification, registration, lifecycle management, and Brazilian certifications such as GMP, INMETRO, and ANATEL.

As a recognized expert in ANVISA regulations, she has actively contributed to Regulatory discussions and the development of industry frameworks.

Throughout her career, she has held key leadership and consulting roles at major multinational companies, including Kenvue, Bausch + Lomb, Bausch Health, Valeant, and Zambon, as well as leading Brazilian firms like Probiotica, Delta, Bunker, and Dorsay & Monange.

Fernanda Ramos is a Regulatory Affairs professional with over 4 years of experience in the healthcare industry. She specializes in Regulatory compliance for Mexico's pharmaceuticals, medical devices, Cosmetics, and dietary supplements.

Her expertise includes COFEPRIS submissions, GMP requirements, product classification, and health registrations. She has successfully led national and international Regulatory projects across multiple sectors.

With a Master’s degree in Quality Management, she remains committed to ongoing professional development. She is known for her precision in dossier preparation and her strategic approach to Regulatory pathways. Her work ensures product safety, efficacy, and full legal compliance.

Ms. Rong Di holds a Master's degree in Medicinal Chemistry from Shenyang Pharmaceutical University and currently serves as the Director of the Medical Device Department at the China Chamber of Commerce for Import & Export of Medicines & Health Products (CCCMHPIE). She has long been engaged in coordinating and promoting foreign trade in the healthcare industry, primarily responsible for coordination, guidance, consultation, and services in the medical device import and export sector, as well as monitoring key products and conducting market operation research and analysis. Ms. Rong has authored numerous research reports for government decision-making reference and participated in related research projects, publishing dozens of industry analysis articles in professional publications such as "Medicine Economic News" and "China Pharmaceutical News." Additionally, she promotes the internationalization of the industry, conducts international exchanges and cooperation, and organizes industry conferences and forums.

Ms. Chen Jingjing holds a Master's degree in Economics from York University, Canada, and currently serves as the Deputy Director of the Medical Device Department at the China Chamber of Commerce for Import & Export of Medicines & Health Products (CCCMHPIE). She also holds the positions of Secretary-General of the Medical Dressings Branch and Secretary-General of the Massage and Healthcare Equipment Branch of the Chamber. Ms. Chen is responsible for industry coordination, policy research, and trade promotion in the medical device, medical dressings, and massage and healthcare equipment sectors.