Medical device development and registration in Mexico.

Review the development steps, tests, and documents for your device’s registration. Select your project stage.

Select project stage

The eight-step guide is free. The kit and annexes require a portfolio download.

Where are you in the process?

Select your project stage. You can change it later.

8-step guide

Each step lists questions, documents, and checks. Review them again when the product changes.

1. Intended use

Define what your product does and for whom. Intended use connects design requirements, claims, evidence, labeling, and regulatory strategy.

Start with this formula

[Product] intended for [medical action] in [population] for [condition], used by [user] in [environment].

Example: A portable device intended for non-invasive monitoring of muscle activity using surface electromyography in adults and adolescents during physical rehabilitation, used by physiotherapists in clinics and therapy centers.

Decisions to resolve

  • What medical action does it perform, and for which condition?
  • For which population, by which user, and in which environment?
  • Which claims can you support with evidence?

“Innovative technology that improves health” does not define an intended use. Avoid promising benefits you cannot yet demonstrate.

Your deliverable

A 1–3 sentence intended use + indication + main claim.

Download portfolio and access kit

My working kit

Your answers are saved only in this browser. Export a copy to keep or share them. Do not enter patient data.

Restoring your progress…

Worksheets and checklist

The kit includes worksheets, a checklist, annexes, and references. Download the portfolio to access it.

Enter your email to download the portfolio and access the kit.

Included in the kit

  • Intended use, classification, and responsibility worksheets
  • Evidence checklist with status, owner, and target date
  • SOP planning, software/AI, and development gate reviews
  • Saved progress and CSV / JSON exports
  • Annexes, glossary, and official references
  • Kenko portfolio download

Example: Intended use → Pending → Owner → Target date → Evidence/version.

Annexes and references

Download the portfolio to access annexes and references.

Development roadmap session

We review your product and its intended use. You receive a preliminary roadmap, three priority gaps, and a summary of the next tasks.

  • Pre-session intake and information review
  • Project decisions, assumptions, and dependencies
  • Written tasks and priorities
Ask about scope and pricing

Paid service, with scope and pricing agreed before booking. Testing, a complete dossier, and quality system implementation are outside this session.