Mexico Medical Device Registration (COFEPRIS – Comisión Federal para la Protección contra Riesgos Sanitarios)
1. Regulatory Authority & Framework
Medical devices in Mexico are regulated under:
- Ley General de Salud (General Health Law)
- Reglamento de Insumos para la Salud (RIS)
- NOM Standards (Mexican Official Standards, e.g., NOM-137, NOM-240)
- COFEPRIS Guidelines for Sanitary Registration
- Equivalency (Reliance) Pathways using FDA/HC/TGA/CE approvals
Authority:
COFEPRIS – Federal Commission for Protection against Sanitary Risks
Mexico relies heavily on equivalence pathways, making it one of the fastest markets in LATAM for internationally approved devices.
2. Device Classification (Class I / II / III)
Mexico uses a three-class, risk-based system aligned with IMDRF/GHTF:
| Class | Risk Level | Examples |
|---|---|---|
| Class I | Low | Non-sterile consumables, basic instruments |
| Class II | Moderate | Infusion sets, monitoring devices |
| Class III | High | Ventilators, implants, HF electrosurgical units, surgical robots |
Classification is based on:
- Intended use
- Invasiveness
- Active/implantable status
- Duration of use
3. Registration Pathways in Mexico
Mexico offers three main pathways:
3.1 Standard Registration (Full COFEPRIS Review)
Required when:
- No international approvals
- Device is novel
- High-risk + complex technology
Requires full dossier + testing per NOM standards.
Timeline: 8–12 months
3.2 Equivalence / Reliance Registration (Fastest Route)
Allowed when device already has approval from:
- US FDA
- Health Canada
- TGA Australia
- Japan MHLW/PMDA
- CE Certificate from EU Notified Body
Benefits:
- Reduced technical documentation
- No in-country testing
- Much shorter review time
Timeline: 3–6 months (very common for global companies)
3.3 Third-Party Review (TPR) / Authorized Third Parties
COFEPRIS authorizes third parties to pre-review submissions.
Benefits:
- Expedited review
- Slightly reduced documentation
- COFEPRIS final approval based on TPR report
Timeline: 2–4 months
4. Local Legal Manufacturer / Registration Holder Requirement
Foreign manufacturers must appoint a Local Registration Holder (LRH / Legal Representative).
The LRH owns the registration:
- Controls dossier
- Manages vigilance
- Appears on labeling
- Essential for renewals & variations
Strategic LRH selection is critical (similar to Brazil’s BRH structure).
5. Dossier Requirements (COFEPRIS Technical File)
Administrative Documents
- Application form
- Proof of LRH authorization
- Free Sale Certificate (Apostilled)
- ISO 13485/QMS
- Power of Attorney
- Certificate of Analysis / sterilization reports (if sterile)
Technical Documents
- Device description
- Intended use & indications
- Risk management (ISO 14971)
- Performance & safety data
- V&V (biocompatibility, EMC, electrical safety IEC 60601, etc.)
- Clinical evaluation (Class II/III)
- Labeling (Spanish mandatory)
- Instructions for Use (IFU) in Spanish
- Packaging validation
For reliance submissions:
- CE/FDA certificate or Health Canada/TGA license replaces many technical sections.
6. NOM Standard Compliance (If Required)
Mexico applies NOM technical standards, including:
- NOM-137 (electrical medical equipment safety)
- NOM-240 (good manufacturing practices for medical devices)
- NOM-241 (sterility and quality controls)
Many NOMs align with IEC/ISO, reducing testing burden for CE/FDA devices.
7. Fees & Timelines
COFEPRIS Fees
- Class I: ~USD 800–1,200
- Class II: ~USD 1,200–2,000
- Class III: ~USD 2,000–3,500
Timelines
| Pathway | Timeline |
|---|---|
| Equivalence (FDA/CE/HCan/TGA) | 3–6 months |
| Third-Party Review (TPR) | 2–4 months |
| Standard COFEPRIS Review | 8–12 months |
| Renewal | 2–4 months |
Registration validity: 5 years (renewable)
8. Labeling Requirements
Mexico requires Spanish-language labeling:
- Product name, model
- Manufacturer & LRH details
- Instructions for Use
- Storage conditions
- Lot/serial number
- Sterility details (if applicable)
- Importer details
- Registration number (post-approval)
English documentation accepted during submission, but labels must be Spanish.
9. Importation Requirements
To import into Mexico:
- Importer must hold Sanitary Import Permit
- Product must have valid COFEPRIS registration
- Customs clearance via SAAI
- Packaging must match approved Spanish labeling
10. Post-Market Surveillance
Required under COFEPRIS:
- Adverse event reporting
- FSCA (Field Safety Corrective Actions)
- Complaint handling
- Renewals & modifications (per COFEPRIS guidelines)
- Retention of records
11. Consulting Notes for Your Device Portfolio
| Device Type | Class | Mexico Registration Notes |
|---|---|---|
| Soft contact lenses | Class II/III | Clinical data + material safety; CE/FDA speeds pathway |
| Surgical robots / AR-MR navigation (SyngAR™) | Class III | Equivalence route possible (FDA/CE); strong software documentation |
| HF electrosurgical units | Class III | Requires IEC 60601-2-2; reliance pathway recommended |
| Blood glucose meters & strips | Class II/III | ISO 15197 performance; reliance possible |
| Single-use serum preparation kits | Class II | Sterilization validation key; fast approval via equivalence |
12. Advantages of the Mexico Market
- Reliance pathway = one of LATAM’s fastest approvals
- Strong acceptance of FDA/CE/TGA/Health Canada data
- Huge patient population and private hospital growth
- Spanish-speaking labeling enables easier expansion to LATAM
- 5-year certificate validity