Regulatory HS

Health Registrations

What is a Health Registration?

Official document issued by COFEPRIS, certifying that your product has been evaluated in terms of its safety and effectiveness by the Health Authorities and was found to be in compliance; hence, its commercialization in national territory is authorized, as it is not considered a risk for Mexican population.

In which situations do you require a Health Registration?

If you want to commercialize in Mexico any of the following products, whether is national or foreign manufacturing:

  • Allopathic medicines.
  • Herbal medicines.
  • Vitamins.
  • Homeopathic medicines.
  • Vaccines.
  • Blood derived products.
  • Biomedicines.
  • Pesticides.
  • Plant nutrients.
  • Medical equipment.
  • Prosthesis.
  • Orthosis.
  • Functional aids.
  • Diagnostic Agents.
  • Dental supplies.
  • Surgical supplies.
  • Healing supplies.
  • Hygiene products.

Do food supplements require a Health Registration?

It will depend on whether the Health Authority considers it a medicine or a food supplement.

In case it is considered a medicine, you will need to register it.

In case it is considered a food supplement, you will need to have an official document that accredits it.

I would like more information on this.

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