1. Certification Overview
In order for all medical devices, pharmaceuticals, and medical supplies (including consumables) imported into Mexico and coming into contact with the human body to be imported, distributed, or sold in Mexico, a Sanitary Registration Certificate (Registro Sanitario) issued by the Mexican Ministry of Health must be obtained. To obtain this registration, one must undergo the document submission process prescribed by the Ministry of Health.
All electronic medical devices must obtain a safety certificate under the Official Mexican Standards System (NOM, Norma Official Mexicana, Informacion Comercial-Disposiciones generals para Productos).
The Secretariat del Salud (SSA) is the parent agency of COFEPRIS, and medical devices can be sold in the Mexican market after receiving approval from COFEPRIS, along with authorization from the SSA.
2. Regulatory Bodies & Basic Information
| Regulatory agencies | SSA (Secretaria del Salud) |
| Certification body | COFEPRIS |
| Language | Spanish |
| Agent | Local agent required |
3. Medical Device Classification
| Class | Risk | Example | |
|---|---|---|---|
| Class III | High risk | • Central Circulatory & Neurological Implants: Cardiac pacemakers, Neurostimulators, Drug-eluting stents • Deep Tissue Injectables & Materials: Hyaluronic acid dermal fillers, Absorbable surgical sutures, Orthopedic implants • Life-Sustaining Equipment: Mechanical ventilators, Defibrillators |  Neurostimulators |
| Class I | Low risk | • Non-invasive Support Materials: Elastic bandages, Surgical caps & gowns, Cotton applicators • Hospital Support Furniture: Crutches, Manual hospital beds, Examination tables • Manual Surgical Instruments: Non-powered scalpel handles, Surgical forceps, Tongue depressors • Basic Diagnostic Tools: Mechanical stethoscopes, Neurological hammers |  Cotton applicators |
| Class II | Moderate risk | • Powered Diagnostic & Therapeutic Devices: Blood pressure monitors, Hearing aids, Powered surgical instruments • Short-term Invasive Consumables: Hypodermic syringes with needles, Contact lenses, Intravenous infusion sets • Energy-based Aesthetic Devices: Medical LED masks, Microcurrent skin stimulators |  Powered surgical instruments |
4. Certification Process
- Submission of application form and related attachments
- Document Review and Notification
- 15 working days: When a technical report is submitted by a third-party organization approved by the Secretariat of Health stating that the product complies with all requested efficiency, technical, and safety requirements
- 30 working days Class I: It is a very well-known product in the medical field with proven efficiency and safety, and is an item that is not inserted into the human body.
- 35 working days Class II: Products that are very well-known in the medical field, or products where various raw materials or different parts may be used during manufacturing, and which are inserted into the human body and remain in place for up to 30 days.
- 60 working days Class III: In cases where new raw materials are used for new products or newly approved in the medical field
5. Required Documents
| Administrative & Legal Documents | • Application Form for Medical Device Sanitary Registration (SSA-03-022-A) – 1 Original and 1 Copy 1) Name, address, and phone number of the local legal representative/distributor in Mexico 2) Name, address, phone number, and fax number of the overseas manufacturer 3) Name and address of the local warehouse/company in Mexico where the imported products will be actually received and stored 4) Name and official signature of the local regulatory officer in Mexico • Authorization of the local distributor’s regulatory officer (Sanitary Responsable / Technical Director Authorization) • Local Mexican Sanitary License and Visit Certificate (Sanitary License / Operating Authorization) • Consularly Notarized Agent/Distributor Agreement (Authorized Distributor Agreement) • Certificate of Free Sale (CFS) issued by the government of origin • Payment Receipt of Government Fees |
| Quality Management System Documents | • Good Manufacturing Practice (GMP) Certification (ISO 13485) • Description of the Manufacturing Process |
| Technical and Safety Verification Documents (Technical Dossier / Information Acceptance Clause) | • Technical Information & Specifications • Original Manufacturer’s Certificate of Analysis (CoA) • Product Inspection & Test Reports • Standardized Spanish Label Drafts (Spanish Product Labeling) • Spanish Instructions for Use & Catalog • Bibliographical References |
6. Validity Period and Maintenance
- Initial Registration Validity Period: 5 years
- Renewal / Extension Validity: 10 years
- Submission of Technovigilance Reports (adverse event and safety statistics reports) in Mexico for the past 5 years
- Import Permit: 6 months
- Side effect report
- Immediate public health threat and fatal cases: Report within 3 days (72 hours) of awareness
- Cases of serious adverse effects/injuries: Report within 15 days of awareness
- General defect or global recall action: Report with a Site Safety Action (FSCA) plan within 30 days of awareness.
Source
SSA Homepage