Sep 63 min read

What Is a Marketing Authorization Holder (MAH)?

Marketing Authorization Holder is an entitythat holds the regulatory approval to distribute, sell, and commercialize pharmaceutical products

Sep 26 min read

COFEPRIS Regulation of Nitrosamines in Pharmaceuticals in Mexico

Mar 224 min read

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...

Feb 284 min read

Mexico COFEPRIS Labeling Requirements for Food Supplements under NOM-051-SCFI/SSA1-2010

In Mexico, the Federal Commission for Protection against Sanitary Risks (COFEPRIS) plays a crucial role in ensuring the safety and...

Feb 253 min read

COFEPRIS Advertising Permission for Food Supplements in Mexico

Advertising plays a crucial role in promoting products, including food supplements, in Mexico. However, before launching any advertising...

Feb 172 min read

COFEPRIS Prior Sanitary Import Permit for Food Supplements in Mexico

Introducing food supplements into the Mexican market requires adherence to health legislation and regulatory processes overseen by the...

Feb 152 min read

COFEPRIS Product Classification Consultation for Food Supplements in Mexico

Navigating the regulatory landscape when introducing food supplements into the Mexican market requires careful consideration of various...

Feb 123 min read

Case Study : Mexico Market Research Report for Generic Aerosols Manufacturer

Client Background: A leading African company specializing in the manufacturing and sale of generic aerosols, is poised to expand its...

Oct 24, 20239 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 21, 20233 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 15, 20236 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...

Aug 23, 20235 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 5, 20233 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...

Jul 9, 202310 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.

Jun 26, 20235 min read

Mexico (COFEPRIS) Regulations for Medical Device Registration

COFEPRIS in Mexico governs the regulations for registration of medical devices

Jun 20, 20232 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

Jan 13, 20225 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 at a CAGR of 2.2%. The...

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