REGULATORY HOSTING · MEXICO
Regulatory compliance to access the market in/from Mexico
We support manufacturers and distributors with a local highly specialized regulatory technical team, from legal representation to technovigilance.
Keep updated to the frequent local regulatory amendments
Who
We
Are?
HosTechMed, is a Mexican company specialized in regulatory hosting and representation for foreign manufacturers of medical devices, cosmetics, food supplements, food additives and pesticides that do not have a legal presence in Mexico. We operate exclusively in the regulatory space before COFEPRIS — never in commercial, import or distribution activities — keeping regulatory and commercial roles structurally separate.
Foreign manufacturers commonly rely on local distributors to obtain their regulatory approvals. When the commercial relationship ends, the approval is frequently held hostage until a payment is made — leaving the manufacturer without control of its own regulatory asset. HosTechMed removes that risk by acting as an independent, neutral custodian of the approval, fully decoupled from any distributor.
The
challenge
we solve?
WhY
choose
HOSTECHMED?
Key points
Our model is built to avoid triggering a permanent establishment in Mexico: HosTechMed does not sell, import, distribute, negotiate prices or invoice sales. We provide independent regulatory services only — the commercial relationship with distributors remains directly between the manufacturer and its distributors.
Highly Regulated Sectors and Growth
Products related to human health represent high-growth markets in Mexico. Medical devices, cosmetics, over-the-counter medications, dietary supplements, food additives, and some pesticides require compliance with specific regulations for their sale and distribution.
Medical Devices
Food Additives
Food Suplements
Pesticides
Cosmetics
Foreign manufacturers with no legal presence (facilities or operations) in Mexico, selling through local distributors, who want to keep control of their regulatory assets and reduce commercial dependency
Services
A comprehensive regulatory practice.
Preparation and submission of sanitary registrations
Regulatory hosting: acting as registration holder and responsible party before COFEPRIS
Technovigilance Unit operation for medical devices
Regulated, compliance-only interaction with local distributors.
Distributor audits
Regulatory status briefings for local buyers
Trusted infrastructure for foreign manufacturers entering the Mexican life sciences market