Quick Explainers: Core Concepts
Canada
The compliance model often distinguishes device licensing (for certain classes) from establishment licensing for importer/distributor activities. Your pathway determines which roles and licenses apply.
Mexico
Market access typically runs through a Mexico-based registration-holder / authorized representative structure interfacing with COFEPRIS. Success requires governance over roles, translations, and evidence consistency.
Who Needs This?
- • U.S.-active manufacturers extending to Canada or Mexico.
- • Foreign manufacturers seeking a single North America governance model.
- • Teams needing clean role boundaries with distributors.
What We Deliver
- • Market-entry pathway map aligned to device class.
- • Documentation governance: claims and translations.
- • Audit-ready program management and traceability.
Typical Execution
- ✓ Entry readiness intake & portfolio scope.
- ✓ Canada licensing & Mexico AR coordination.
- ✓ Labeling strategy & translation governance.
Roles & Responsibilities (RACI)
| Area | Your Team | BRS LLC |
|---|---|---|
| Commercial Model | Confirm channels, partners, and launch timing. | Convert into country-specific pathways. |
| Inputs | Provide labeling, intended use, tech summaries. | Run governance and readiness checks. |
| Local Roles | Approve local partners (importers/representatives). | Coordinate workstreams and consistency. |
Pricing & Coverage Options
Scope is driven by country choice, portfolio size, and class mix. Government fees are separate.
Ready to expand without governance gaps?
Expand into Canada and Mexico with audit-ready traceability and structured pace.
Frequently Asked Questions
Can we sell in Canada without restructuring our U.S. approach?
Often yes, but Canada has its own licensing model and role expectations. We map your commercial model to the requirements and keep documentation consistent across markets.
Does Mexico require a local authorized representative?
Typically, yes. Mexico market access generally runs through a Mexico-based structure that interfaces with COFEPRIS. BRS LLC can manage the program while maintaining governance.
What is the biggest expansion risk?
Fragmented ownership—multiple parties editing documents, translations, and claims without a single governance model. We prevent that with controlled playbooks.