How to Use DIGIPRIS for COFEPRIS Regulatory Submissions
In recent years, companies submitting applications in Mexico have had to adjust to a different way of dealing with the
COFEPRIS Compliance
Learn about COFEPRIS requirements for pharmaceuticals, nutraceuticals, and medical devices in Mexico. Our resources cover product registration, labeling rules, and safety standards to help businesses meet local regulations.
Mexico COFEPRIS Labeling Requirements for Food Supplements
Labels of food supplements must say what they intend to do. Only then can they be considered legally acceptable. However,
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. The country has the Federal
COFEPRIS Reliance Pathway in Mexico
Getting a medicine or medical device approved in a new country can involve repeating many of the same regulatory checks
NOM-137-SSA1-2025: Mexico’s New Labeling Standard for Medical Devices
Mexico now requires strict label matching for medical devices. NOM-137-SSA1-2025 replaced the 2008 standard and was published on May 19,
COFEPRIS Medical Device Registration Modification in Mexico
Changing anything on an existing medical device sanitary registration in Mexico, such as a distributor, manufacturing site, label or sterilization
Medical Device Regulations and Registration Process in Mexico
Before entering the Mexican market, medical devices need Registro Sanitario, or Sanitary Registration. Recently, regulatory simplification and a broader abbreviated
Medical Device Regulatory Staffing in Mexico: Case Study
Artixio, a trusted player in the regulatory and commercial arena, provided contract staffing solutions to a global leading medical device
COFEPRIS Nitrosamines Regulations in Mexico Pharmaceuticals
There’s been a lot more attention on nitrosamine impurities lately, especially after similar issues came up in different markets. COFEPRIS