COFEPRIS GMP guidelines – Recent Updates

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Recent updates #COFEPRIS #GMP guidelines are significant and may impact your operations.
COFEPRISCOFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) is #Mexico’s #regulatory authority responsible for safeguarding public health.

It operates autonomously within the Ministry of Health and oversees the #safety, #efficacy, and #quality of #medicaldevices, #pharmaceuticals, and other health-related products.


✅ Good Manufacturing Practices (GMP) are essential for ensuring the consistent quality, safety, and efficacy of medicinal products.

✅ Compliance with GMP guidelines is crucial for manufacturers, importers, and distributors to meet regulatory requirements.

✅ Mexico has its own Good Manufacturing Practices (GMP) requirements. Manufacturers must request COFEPRIS for GMP inspection before submitting the registration dossier. However, manufacturers with GMP certificates from reference countries are exempt from COFEPRIS GMP inspection.

✅ COFEPRIS requires Good Manufacturing Practices Certificates for companies producing medical devices for use in Mexico. To obtain a GMP certificate from COFEPRIS, an application must be submitted with essential documents and an inspection fee.


☑ In March, COFEPRIS updated its GMP guide, providing criteria for evaluating GMP certificates or equivalent documents submitted during medical device sanitary registration requests, modifications, or extensions.

☑ Scope of GMP Guidelines: COFEPRIS GMP guidelines cover various aspects of manufacturing, including facilities, equipment, personnel, documentation, and quality control.
They ensure that pharmaceutical products are consistently produced and controlled according to established quality standards.

☑ GMP Inspection: COFEPRIS conducts inspections to assess compliance with GMP requirements. Manufacturers must demonstrate adherence to GMP principles during these inspections.

☑ Consultation Meetings: Companies can engage in consultation meetings with COFEPRIS to clarify doubts, seek guidance, and address compliance issues.

☑ Registration Fees and Timelines: COFEPRIS charges fees for product registrations. Timelines for registration vary based on the complexity of the product and the completeness of the submission.

✅ Navigating the regulatory landscape can be complex, especially when dealing with COFEPRIS requirements. #FWQRC-Global GxP & Regulatory Consultant serves as a reliable partner, helping companies achieve compliance and successfully bring their products to the Mexican market

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