The Mexican regulatory agency is Mexico’s Federal Commission for the protection against sanitary risks (COFEPRIS) and regulation of health supplies is three tier regulations.

- General Health Law ( Ley General de salud )
- General Health Regulation ( Reglamento de Insumos para la salud )
- Official Mexican standards ( Normas oficiales Mexicanas – NOMs )

• NOM-241-SSA1-2012 : Good manufacturing practices for establishments dedicated to the manufacture of medical devices.
• NOM-137-SSAI-2008 : Labeling of medical devices
• NOM-240-SSAI-2012 : Installation and operation of techno vigilance

In addition, there are some guidelines, which provide guidance on process of registration for production and sale.

• Criteria for the classification of medical devices based on their level of health risk.
• Guidelines to obtain health registration of a medical device as well as authorization to modify registration conditions.

With Partner offices in Mexico, Lexium’s team in Mexico has the expertise to help you navigate COFEPRIS’s regulatory requirements and begin selling your device in Brazil.

The process of COFEPRIS approval is an EIGHT STEP Process:

• Step 1 - Appointment of Mexican registration holder.
• Step 2 - Classification of the device or identifying if the device is deregulated.
• Step 3 - Designating a distributor.
• Step 4 - Preparation of the dossier for submission ( All in Spanish )
• - Deregulated Devices – No Documentation
• - Evidence of Home Country Approval
• - Free Sale Certificate
• - Certificate to Foreign Government
• - Evidence of QMS Compliance ( ISO 13485 )
• - Low Risk Class I Device – Basic Company and Device Information
• - Devices Approved in US, Canada or Japan – Equivalency Dossier
• - Devices not approved in US /Canada or Japan or devices not qualifying for equivalency route, complete technical dossier with literature based clinical evidence, Device specific test reports.
• - Label /IFU
• Step 5 - Compliance with labelling requirement
• Step 6 - Submission to COFEPRIS and a designated “pre-approving “third party agency (not allowed for equivalency route) and fees payment.
• Step 7 - Approval and Displayed in COFEPRIS website
• Step 8 - Furnishing other licenses including import licenses as required, setting up techno vigilance process.

Post Approval Services

Lexium supports the foreign manufacturers in start to end medical device life cycle management, including post approval activities such as :

• Post approval change management, modifications to existing medical device approvals such as addition of new variants, accessories & addition of new indications of use among others.
• Maintenance of approvals and registration through timely payment of administrative & registration fees.
• Renewal of License
• Liaison between COFEPRIS and the manufacturer
• Importation Arrangement

Lexium Expertise
• Regulatory Due Diligence Services
• Official Classification Services
• GMP Certification Services
• MDSAP Certification
• Mexican Registration Holder
• Device Registration Through Regulatory Pathways
• Translation Services
• Labelling Services
• Distributor Identification & Qualification Services
• Operating Permits and Authorization
• Post Approval Change Management
• License Renewal and Transfer Services

Ready to get started – Request a free consultation