Mexico · Federal Commission for the Protection against Sanitary Risks · Medical devices
Review target
-
Not published
Legal time limit
30 working days
regulation
Steps
3
5 requirements
Application fee
-
COFEPRIS can register a medical device already authorized by a regulator that sits on the management committee of the International Medical Device Regulators Forum. The agency checks that the file is complete and decides within 30 working days. Medical devices authorized by a member of the IMDRF management committee, with the same product as the one authorized.
1. File the reliance application; 2. Completeness check and decision period (30 days); 3. Decision.
Yes. It relies on approvals from Australia, Brazil, Canada, Switzerland, China, European Union, United Kingdom, Japan, South Korea, Russia, Singapore, United States (shorter review, shorter review, shorter review, shorter review, shorter review, shorter review, shorter review, shorter review, shorter review, shorter review, shorter review, shorter review).
Outcome: A sanitary registration with the same legal effect as one from the ordinary procedure. Valid for 5 years.
Legal basis: Reglamento de Insumos para la Salud, article 161 Bis; general guidelines for the abbreviated regulatory route 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. 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. Maximum time to issue the decision. It is a legal limit, not an actual review time. | 30 working days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in Mexico: 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, 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 (24 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.