Mexico · Federal Commission for the Protection against Sanitary Risks · Medical devices
Review target
-
Not published
Legal time limit
-
Not published
Steps
2
2 requirements
Application fee
-
Devices on the official list of low-risk devices that do not need registration can be made, sold and distributed without a sanitary registration. They still must meet good manufacturing practice and technovigilance rules. Imports need no import permit, but the importer files a sworn statement at customs. Devices listed in Annex Two of the July 2025 low-risk device lists.
1. Confirm the device is on Annex Two; 2. Sworn statement at customs for imports.
Outcome: No registration. The product can be sold if it meets the other rules.
Legal basis: Ley General de Salud, article 376; agreement on the lists of low-risk medical devices of July 2025
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
Official step durations
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| No time targets published. |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in Mexico: Abbreviated reliance route for medical devices, Registration of a Class I medical device, Registration of a Class II medical device, Registration of a Class III medical device, Simplified registration of listed low-risk devices. See all routes on the Mexico page or explore them in the Regulatory section.
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (5 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.