Sanitary Authorizations

In Mexico, the market for Medical Devices, Medicines and Drugs is regulated by the Federal Commission for Protection against Sanitary Risks (COFEPRIS). For a manufacturer, distributor or importer to carry out commercial activities in national territory, they must have authorization from said commission.

As consultants, we offer our experience in the preparation of dossiers to obtain authorizations before COFEPRIS, strictly adhering to current local regulations on health supplies and devices, with professionalism and total confidentiality.

Below is the list of services we offer:

  1. Review of Information:
    1. Classification of the product according to its characteristics
  2. Assembly of Files For the Request of Sanitary Authorizations
    1. Obtaining health registration
    2. Modifications (technical and administrative)
    3. Extensions for:
      • Generic drugs
      • Medical devices (all classes, all categories)
  3. Registration, Modification And Termination Of:
    1. Operation messages
    2. Health responsible notices
  4. Technovigilance Reports
  5. Review Of The Qualitative-quantitative Formula:
    1. Cosmetics
    2. Food supplements
  6. Labeling Review:
    1. Medical devices
    2. Food supplements
    3. Cosmetics
  7. Assembly Of The File For Authorization To Conduct A Research Protocol In Human Beings For:
    1. Medicine, biological or biotechnological
    2. Genetic medication (bioequivalence study)
    3. Medical devices (new resources)
    4. Observational study without intervention
  8. Request For Amendment To The Protocol For Research In Human Beings (All Modalities)
  9. Review Of Compliance With The Quality Management System For NOM-241-SSA1-2021 (Gap Analysis)
  10. Connections With Potential Clients And Authorized Distributors In The Sector.