Mexico · Federal Commission for the Protection against Sanitary Risks · Medical devices
Review target
-
Not published
Legal time limit
20 working days
regulation
Steps
4
4 requirements
Application fee
-
Devices on the official list of low-risk devices that still need registration use a short file and a decision within 20 working days. COFEPRIS can ask once for missing information. Devices listed in Annex One of the July 2025 low-risk device lists. Sterile devices are never considered low risk.
1. File the application; 2. Review and decision period (20 days); 3. Answer to the request; 4. Decision.
Outcome: A sanitary registration. Valid for 5 years.
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).
About 30 days end to end with the official step targets, of which up to 10 days are clock stops (time the applicant uses to answer). Targets, not actual times.
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Longest clock stopregulation. Time for the applicant to answer a request; it cannot be extended. | 10 working days |
| Legal time limitregulation. Maximum time set in the agreement, not an actual review time. | 20 working days |
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, Low-risk devices exempt from registration. 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 (14 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.