Also known as: Sanitary registration, COFEPRIS registration
An official authorization issued by COFEPRIS certifying that a regulated product meets safety, efficacy, and quality requirements for commercialization in the Mexican market.
Health registration is the official authorization COFEPRIS grants for a product to be legally commercialized in Mexico. It is mandatory for pharmaceuticals (allopathic, homeopathic, herbal), medical devices, pesticides, plant nutrients, and some high-risk foods. The registration process includes technical documentation review, stability studies, laboratory analysis, and for pharmaceuticals, clinical and bioequivalence studies. Health registration validity is 5 years, renewable.
COFEPRIS Permit
An authorization issued by Mexico's Federal Commission for Protection Against Health Risks to import regulated products such as pharmaceuticals, medical devices, processed food, pesticides, and cosmetics.
RegulationsSanitary Requirement
A mandatory regulation establishing hygiene, food safety, and security conditions that imported products for human consumption or affecting public health must meet.
RegulationsGood Manufacturing Practices (GMP)
A set of guidelines and procedures ensuring products are consistently manufactured under quality, hygiene, and safety standards appropriate for their intended use.
RegulationsNon-Tariff Barriers (NTBs)
Measures other than tariffs that countries impose on international trade to protect health, safety, environment, and domestic industry.