Market Healthcare Products in Mexico

The COFEPRIS registration must be obtained before any commercial application for the following types of products:

  • Cosmetics
  • Medical Devices
  • Sanitary Products
  • Pharmaceuticals drugs
  • Food & Supplements

COFEPRIS General Guidelines

  • Registration must be requested through a local and reputable Mexican company
  • The registration is always held by the company that filed the application.EXCLUSIVELY for five years
  • The company must be in good standing and fully authorized by COFEPRIS.
  • This procedure is different and more complex than FDA.
  • The application process takes 6 to 12 months at least, before your registration goes into effect.

Three Options Only to access the Mexican market

Cost Implementation Risk Level

Having your own local subsidiary


  • Property Investment(s)
  • Employing a doctor and / or pharmacist.
  • Business trips.

12 to 18 months

  • Creating a business structure.
  • Registering your affiliate.
  • Registering your products.


  • Legal risks.
  • Salery and wage risks.
  • Commercial failure risks.
  • Automonomy,and independence.

Outsourcing to one of your local distributors


  • Negotiating and ratifying a contract.
  • Often with a reference product and high commission.
  • Annual negotiation

10 to 12 months

  • Language and translation barriers
  • Lack of responsiveness
  • Lack of transparency.

Very High

  • Legal risks (Mexican contracts law).
  • Commercial risks (Competing products).
  • Exclusive ownership rights
  • Obligation to rely on Distributor.

Working with trusted third party specialized in regulatory issues (Master Distributor)


  • Materialisation of a clear quote
  • Amount fixed per product and digressive
  • No success fee

8 to 10 months

  • Expedited process based on access and established relationship with COFEPRIS
  • Bilingual contact.
  • Writing and project management provided in our services
  • Transparency and total autonomy.


  • No salary, structure or fixed costs
  • Registration held by a trusted third party driving the follow-up locally
  • No exclusivity, several regional distributors proposed

We aim to:

  • Become your regulatory partner
  • Be your administrative and commercial intermediary
  • Register your products and/or business using a local law firm
  • Keep and host your records and licenses
  • Offer pharmacovigilance and technovigilance services for your registered products through our own ANVISA approved laboratory.

This solution has many advantages:

  • You remain independent and autonomous
  • You choose all local distributors freely
  • You can determine for yourself when and how you want to sell your products
  • We take care of your regulatory and administrative requirements…
  • We bring you the guarantee of a European organization with a solid team of professionals, that is respectful of legal and ethical principles

Contact Us

Should you have any questions or request for information about our services, please fill out the form below. We will do our best to reply shortly.
Our sales team is attending most of major healthcare events across the world, it is also possible to request for a meeting in a specific trade show or congress.