COFEPRIS Requires Good Manufacturing Practices Certificates in Mexico for Medical Devices
Companies producing medical devices for use in Mexico must have Good Manufacturing Practices Certificates.
One of the largest importers of medical devices, as well as a significant producer of such products, in the world, and certainly significant in Latin America, is Mexico. Although, this is the case, however, there is some confusion as to what Mexico’s requirements and regulations are for medical device imports, and manufactures. This is often due to the fact that they are often published exclusively in Spanish. This post is for the purpose of presenting some basic information in English that is related to the subject.
What are Good Manufacturing Practices Certificates (GMPs)?
To ensure manufacturing safety and product quality, manufacturing procedures are implemented for the issuance of Good Manufacturing Practices Certificates, which certify that industry accepted procedures and practices are being implemented and taught to operators. In most countries, these certificates of Good Manufacturing Practices are issued by a governmental body, like the FDA in the US – but some countries rely on private companies to issue them.
What is COFEPRIS?
COFEPRIS is an acronym for the Comisión Federal para la Protección contra Riesgos Sanitarios, of the Federal Agency for Protection Against Sanitary Risks. It is the agency charged with overseeing quality of medical devices and products made in and imported into Mexico. COFEPRIS main mission is the formulation, promulgation and enforcement of regulations that pertain to the importation of medical devices and other medicinal products and works to ensure their safety and quality.
How Are Medical Devices Registered in Mexico?
Mexico requires an application for all medical device manufacturers, both domestic and foreign, when selling into the Mexican marketplace. At the time of application, all devices to be registered must have Good Manufacturing Practices Certificates (an original or a notary-certified copy) issued by one of the following regulatory organizations:
COFEPRIS and/or a COFEPRIS-recognized international health authority. These include:
- FDA (USA)
- ANVISA (Brazil)
- Health Canada (Canada)
- EMA (EU),
- Pharmaceutical and Safety Bureau (Japan)
- TGA (Australia)
What is the registration process in Mexico?
Registration in Mexico generally follows six steps. They are:
1. Determine the class: the rules are fairly standard, but time and cost can vary greatly. It is therefore important to consult COFEPRIS rules on classification for all devices.
2. Appoint a Local Registration Holder: if the device was manufactured outside of Mexico, it will need a registration holder inside the country licensed by COFEPRIS; many companies have their
3. Acquire GMP certificates: as discussed above, applications must be accompanied by applicable GMP certificates.
4. Compile and attach further documentation to application: required documents are listed in Reglamento de Insumos para la Salud, Article 179.
5. Submit required documents to COFEPRIS: the registration holder must submit these documents to COFEPRIS and wait 30-60 days for registration decisions.
6. Certificates issued and confirmation posted on Ministry of Health website: if COFEPRIS does not inform the manufacturer in writing of any issues with the application, registration confirmation and ID number are posted on the website for Mexico’s Ministry of Health.