Product Registration in Mexico

Mexico is considered the second biggest market in Latin America, being a profit target for manufacturers, mainly for those that are located in the US and Canada.

The COFEPRIS is an internal division of the Mexico’s Ministry of Health (Secretaria de Salud), responsible for the supervision of the products. The requirements adopted by the competent mexican Authority, for purposes of product’s regularization in the country, are few detailed, being that the information available by COFEPRIS are available only in English.

The Passarini Regulatory Affairs, counts with a team that can assist your company in the the obtainment of the approval of your registration, including being able to provide:

  • Product Classification;
  • Execution of the technical dossier of register with the COFEPRIS;
  • Give progress and possible answers to the COFEPRIS’s questions during the submission process of registration;
  • Act like your Mexican Hosting Service.

The Passarini Regulatory Affairs shall provide a detailed check-list of all documentation required for your product registration:

  • Just below are the description of some of the required documents:
  • Technical and scientific information that confirm the safety and efficacy of the product;
  • Detailed Product Description;
  • Laboratory tests, if applicable;
  • Certificate of Free Sale of the Ministry of Health from the origin country;
  • Current Certification ISO 13485, CE marking or Declaration of Conformity with the US GMP included in the Certificate of Sale;
  • List of accessories/components, if applicable;
  • Labelling and instruction manual (spanish)
  • Manufacturing Process/overview of the sterilisation method
  • Clinical Studies, if applicable

The COFEPRIS takes around from 4 to 12 months for manifestation about the register request, and charges registration fees by product (which vary depending on the classification), in addition, the registration is valid for 5 years.

 

Contact us for more information about the approval of your product with the COFEPRIS and the possibility for us to become the hosting service.