REGULATORY HOSTING · MEXICO

Regulatory compliance to access the market in/from Mexico

We combine specialized regulatory expertise with purpose-built physical and digital infrastructure to support manufacturers throughout the regulatory lifecycle in Mexico.

“Trusted infrastructure for foreign manufacturers entering the Mexican life sciences market”

Physical presence. Digital continuity. Regulatory control

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.


When the commercial relationship ends, the manufacturer may lose practical control of the approval or face significant friction when transitioning distributors. HosTechMed addresses that risk by acting as an independent, neutral custodian of the regulatory approval, structurally separate from commercial relationships.”

The

challenge

we solve?

WhY

choose

HOSTECHMED?

Key points

Boutique, high-touch attention
Deep regulatory specialization
Clear legal and corporate governance
Robust physical and digital infrastructure
Digital tools providing 24/7 access to your regulatory file 
Full transparency and document accessibility 

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 

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 

Our facilities comply with all local regulatory requirements

Purpose-built physical and digital infrastructure designed for regulatory continuity, security and control.