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 […]
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.
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,
Cosmetic Regulations & Compliance Process in Mexico
For cosmetic brands and regulatory teams, Mexico often looks straightforward, as there’s no pre-market registration. In reality, delays happen at
COFEPRIS Drug Registration Process in Mexico
Many companies entering Mexico underestimate how detailed the pharmaceutical regulations in Mexico can be. Once the application reaches COFEPRIS, extra
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
COFEPRIS Food Supplements Regulations in Mexico
Food supplements are regulated by COFEPRIS in Mexico. The requirements can cover different areas, from product classification and ingredients to
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
Mexico Cosmetics Labeling & GMP for COFEPRIS Compliance in Mexico
Normal cosmetic products do not need to be registered before entering the market. But companies have the responsibility to make
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