Mexico · Federal Commission for the Protection against Sanitary Risks · Medical devices
Review target
-
Not published
Legal time limit
30 working days
regulation
Steps
3
8 requirements
Application fee
MX$16,499
2026
Class I devices need a sanitary registration unless they are on the list of exempt low-risk devices. The regulation gives COFEPRIS 30 days to decide. If it does not decide in time, the application counts as approved. Devices known in medical practice with proven safety and efficacy that generally do not enter the body. This includes diagnostic agents and software as a medical device in this class.
The application and registration of a class i device is MX$16,499 for 2026.
1. File the application; 2. Review and decision period (30 days); 3. Decision.
Outcome: A sanitary registration valid for 5 years, renewable for 10-year periods. Valid for 5 years.
Legal basis: Ley General de Salud, articles 262 and 376; Reglamento de Insumos para la Salud, articles 82, 83 and 179 to 181
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. 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
| Legal time limitregulation. Legal limit, not an actual review time. Shorter times have been announced; see the list of rule changes. | 30 working days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Application and registration of a Class I deviceApplication · 2026 | MX$16,499 |
Other routes in Mexico: Abbreviated reliance route for medical devices, Registration of a Class II medical device, Registration of a Class III medical device, Simplified registration of listed low-risk devices, 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 (19 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.