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

High

  • 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.

Medium

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

Outsourcing to one of your local distributors

Moderate

  • 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)

Low

  • 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.

Low

  • 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

Procedure

While Mexico represents a growing market with a population of 110 million inhabitants and is the second largest medical device market in Latin America behind Brazil, it is also one of the most confusing, and time-consuming (administrative and protectionist) markets to navigate.

Our dedicated guidance is intended to illuminate and let you access this country’s business culture making it easier for you to make realistic and cost beneficial decisions, while at the same time leaving you free to choose your Mexican distributors and buyers.

    Distributor Search (Optional)

  • 3 months survey
  • Meetings with future and potential partners, distributors, etc... for a week in Mexico

    First Meeting and Personalized Consultation.

  • Presentation of our sales teams and techniques.
  • Examination and Corroboration of your penetration strategy, the products, and the market.

    Authorization to Carry Out a Preliminary Analysis

  • Securing and Assessing the legal and economic framework.
  • Pricing based on the number of products concerned.

    Audit and Preliminary Findings

  • Determination of the product category (single, family, or system).
  • Definition of regulatory prerequisites (registration or notification).
  • Evaluation of classification within the definition of COFEPRIS,
  • Identification of other required certifications.

    Services and Contract

  • Determination of fees for necessary registration or notification.
  • Assessment of COFEPRIS taxes.
  • A five-year economic business plan for hosting.
  • Examination of all legal and regulatory requirements.

    Procedure for registration or notification.

  • Writing and developing appropriate presentation documents.
  • Validating certifications.
  • Filing and following up with relevant agencies.

    Official Mexican Publication (COFEPRIS website)

  • Proofreading of the registration certificates.
  • Ensure the issuance of administrative documents.
  • Start selling your product.

    Monitoring and Securing Business Environment

  • Maintain records.
  • Alert you to changes in regulatory requirements and certifications.
  • Audit selected distributors to ensure legal compliance, COFEPRIS requirements,and financial health.
  • Issue and track Import Letters