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COFEPRIS Makes Changes to Revamp Medical Device Regulations
In a significant regulatory update, Mexico’s Federal Commission for the Protection against Sanitary Risk (COFEPRIS) has introduced new...
Mar 22, 20244 min read

Pharmaceutical Registration Process in Mexico (COFEPRIS)
Mexico is a major market in LATAM region. Pharmaceutical importation is expected to grow to $4.4 bn by 2024 ata CAGR of 2.2%. The...
Dec 18, 20234 min read

COFEPRIS Technovigilance of medical devices in Mexico
In the dynamic landscape of healthcare, ensuring the safety and efficacy of medical devices is paramount. As technology continues to...
Nov 13, 20234 min read

Cosmetics Labeling for COFEPRIS compliance in Mexico
NOM-141-SSA/SCFI-2012 is a Mexican standard that establishes labeling requirements for prepackaged cosmetic products. This standard...
Nov 5, 20232 min read


Artixio’s Regulatory Support for a Chinese Pharmaceutical Manufacturer in Mexico
A case study outlining Artixio’s Regulatory Support for a Chinese
Pharmaceutical Manufacturer in Mexico.
Nov 4, 20232 min read

Notice of Operation : Essential Pre-requisite for registration of products with COFEPRIS, Mexico
A Notice of Operation in Mexico, or Aviso de Funcionamiento en México, is a document that must be filed with the Mexican Ministry of...
Nov 3, 20233 min read

DIGIPRIS: Mexico COFEPRIS Digital Platform for Product Registrations and Regulatory Submissions
The DIGIPRIS system (Sistema Digital de Procesos y Servicios Regulatorios, or Digital System of Regulatory Processes and Services) is a...
Oct 30, 20233 min read

The Mexico COFEPRIS Good Manufacturing Practices (GMP) Requirements for Cosmetics
The Mexican Official Standard NOM-259-SSA1-2022 outlines comprehensive regulations covering various aspects of good manufacturing...
Oct 24, 20239 min read

Local Representative for MDR in Mexico:Mexican Registration Holder (MRH) for COFEPRIS Communications
In recent years, Mexico has emerged as a highly attractive destination for businesses looking to expand their operations, particularly in...
Oct 21, 20233 min read

Medical Devices Regulations in Mexico: COFERIS QMS compliance Requirements under NOM-241-SSA1-2021
Mexico, a thriving and expanding market for medical devices, presents its distinct regulatory framework that manufacturers must adeptly...
Oct 15, 20236 min read

Biologics and Biosimilars Regulations and Registration in Mexico (COFEPRIS)
Mexico is the second-largest drug market in Latin America, after Brazil. With a compound annual growth rate (CAGR) of 38.7%, the Mexican...
Aug 23, 20235 min read

Nutraceutical & Dietary supplements regulations in Mexico
Mexico's nutritional supplements market is set to expand from $9.2 Mn in 2022 to $14.96 Mn by 2030, exhibiting a CAGR of 7.4%. The...
Aug 5, 20233 min read


FAQ - Mexico (COFEPRIS) Regulations for Medical Device Registration
Here are answers to some of the Frequently Asked Questions about Mexico Medical Device Regulations.
Jul 9, 202310 min read


Mexico (COFEPRIS) Regulations for Medical Device Registration
COFEPRIS in Mexico governs the regulations for registration of medical devices
Jun 26, 20235 min read


COFEPRIS Introduces Changes to Drug Registration Process in Mexico
The Mexican health authority, COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios), has a new drug registration process
Jun 20, 20232 min read

Case Study: Global Regulatory Intelligence for Dental Brand
Analysis of regulatory pathway for registration of cosmetic/dental care products in target countries
Jan 17, 20222 min read


Pharmaceutical Registration Process in Mexico (COFEPRIS)
COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) is the regulatory authority responsible for pharmaceutical...
Jan 13, 20227 min read
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Deep dive and engage in insightful discourse driven by concurrent global regulatory scenarios, industry trends and Artixio’s real-time experience across the product value chain. Whitepapers, research articles, landscape reports and case studies to help you stay ahead of the curve.
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