Standard Registration Route
The Standard Registration Route (also called the full dossier This route is mandatory for devices without approval from a recognised Reference Regulatory Authority (RRA) or when the device version differs from an RRA-approved version. route) requires a comprehensive technical dossier submitted directly to COFEPRIS. It applies when:
- The device does not have approval from a recognised Reference Regulatory Authority (RRA), or
- The device version submitted is not identical to an RRA-approved version, or
- The equivalency route is otherwise not available.
Who submits
The application is submitted by the Mexico Registration Holder (MRH) via the DIGIPRiS portal. Domestic manufacturers submit directly.
Dossier contents — general requirements
| Document | Notes |
|---|---|
| Device description & intended use | Clear description in Spanish of the device and its intended clinical use |
| Design specifications | Technical drawings, materials, dimensions, manufacturing process overview |
| Biocompatibility data | Per ISO 10993 where applicable (implants, blood-contacting devices) |
| Clinical evidence | Literature review, clinical study reports, or clinical evaluation (extent varies by class) |
| Risk management summary | Based on ISO 14971 |
| GMP evidence | NOM-241 compliance certificate, ISO 13485 certificate, or equivalent |
| Labelling (draft) | Spanish-language label compliant with NOM-137-SSA1-2008 |
| IFU / Instructions for Use | In Spanish |
| Proof of MRH appointment | Power of attorney from manufacturer to MRH |
| Proof of fee payment | Pago de derechos |
For standard route submissions, COFEPRIS permits use of a designated pre-approving third-party agency to review the dossier before formal COFEPRIS review. This can reduce deficiency letters and improve first-pass success rates. This option is not available for the equivalency route.
Timelines by device class
| Device class | Target review time |
|---|---|
| Annex 1 (low risk) | 20 business days |
| Class I | 20–30 business days |
| Class II | 30–60 business days |
| Class III | 60–180 business days |
These are target timelines. Actual timelines can vary based on COFEPRIS workload and any deficiency letters requiring applicant response.
After submission
- COFEPRIS will review the dossier and may issue a deficiency letter (prevención) requesting additional information or corrections. Respond within the stipulated period to avoid abandonment.
- On approval, COFEPRIS issues the sanitary registration with a unique homoclave and lists the device on the COFEPRIS public register.
Post-approval modifications
Changes to the registered device — including changes to the device itself, labelling, manufacturer, MRH, or distributor — must be notified to or approved by COFEPRIS via a modification application through DIGIPRiS. The nature of the change determines whether a prior approval or notification is needed.
Related pages
- Equivalency Route
- Technical dossier requirements
- Registration fees & timelines
- DIGIPRiS portal
- Labelling — NOM-137
Third-party pre-review
"The designated pre-approving agency reviews the dossier for completeness and COFEPRIS compliance before formal submission, typically within 15–20 business days. This pre-review is optional but recommended, as it significantly reduces deficiency letters. The pre-review timeline is separate from the official COFEPRIS review clock; the clock begins when the complete dossier is formally submitted to COFEPRIS via DIGIPRiS."