Best FDA Law Lawyers in Mexico

Share your needs with us, get contacted by law firms.

Free. Takes 2 min.

Or refine your search by selecting a city:

Justicia Transparente

Justicia Transparente

1 hour Free Consultation
Tijuana, Mexico

Founded in 2000
30 people in their team
English
Spanish
Business FDA Law Tax +2 more
We are a firm specializing in criminal and immigration law with a presence throughout Mexico. We have lawyers in the major cities of Mexico, such as Tijuana, Mexico City, Cancun, Puerto Vallarta, Los Cabos, Guadalajara, Monterrey, and Tapachula, Chiapas. We specialize in dealing with criminal...
BLX GROUP
Puebla, Mexico

Founded in 2021
5 people in their team
Spanish
Business FDA Law Office Solutions +4 more
Somos una firma legal que ofrece soluciones jurídicas y corporativas a empresas. A diferencia de todas las firmas existentes, nuestra labor radica en la prevención y planeación a través de estrategias innovadoras y de mejora.nuestro objetivo principal es diseñar y administrar departamentos...
Ojeda y Caro S. C.
Cancún, Mexico

Founded in 2016
20 people in their team
English
Portuguese
Spanish
French
Korean
Business FDA Law International +3 more
About UsWith over four decades at the legal forefront, our firm stands out in delivering expert consultation and representation for domestic and international enterprises. Our practice is anchored in a pro-business ethos, designed to amplify our clients' benefits while minimizing risk through...
Reséndiz Abogados Asociados
Puerto Vallarta, Mexico

Founded in 1995
5 people in their team
English
Reséndiz Abogados Asociados stands as a distinguished legal firm, renowned for its comprehensive expertise across multiple practice areas including administrative law, civil law, and business law. With a rich history of providing exemplary legal services, the firm's team of skilled attorneys...
MT Law Abogados
Mexico City, Mexico

Founded in 2014
3 people in their team
English
MT Law Abogados, based in Querétaro, Mexico, specializes in providing comprehensive legal services in business law. Their offerings include integral legal advisory, corporate secretarial services, contract drafting and management, labor consultancy, and extrajudicial debt collection. The firm's...
ILP GLOBAL BITAR ABOGADOS
Mexico City, Mexico

Founded in 2016
3 people in their team
English
ILP Global Bitar Abogados is a renowned law firm specializing in a wide range of legal services, including bankruptcy, general practice, and business management consultation. Known for its formidable expertise in both local and international law, the firm has established a strong reputation for...
Saltillo, Mexico

Founded in 1948
3 people in their team
English
Fredrikson & Byron, P.A. is a leading law firm renowned for its comprehensive expertise in a wide array of practice areas, including corporate law, mergers and acquisitions, real estate, and intellectual property. With a distinguished reputation for delivering strategic legal solutions, the firm is...
DEFENSA AGRARIA ABOGADOS
Texcoco, Mexico

Founded in 2025
3 people in their team
English
DEFENSA AGRARIA ABOGADOS is a distinguished law firm with over 21 years of experience specializing in agrarian law. The firm provides comprehensive legal services to ejidatarios, comuneros, possessors, residents, ejidal nuclei, and indigenous communities, ensuring reliable and thorough counsel....
Guadalupe Victoria, Mexico

Founded in 2012
3 people in their team
English
Littler Mexico, S.C. stands as a leading authority in labor and employment law within the corporate sector, offering comprehensive legal solutions tailored to meet the intricate needs of businesses. With an esteemed reputation for deep expertise, Littler Mexico adeptly navigates the complexities of...
Cervantes Estudio de Abogados
Mexico City, Mexico

Founded in 2020
50 people in their team
Spanish
English
We are a multidisciplinary firm strongly planted as one of the most efficient and prestigious in the Mexican and international legal market.Our lawyers are professionals recognized for their high level of sophistication, specialization and quality in different areas of Law, especially in unusual...
AS SEEN ON

Browse fda law law firms by city in Mexico

Refine your search by selecting a city.

About FDA Law in Mexico

FDA Law in Mexico refers to the legal framework governing the regulation of food, drugs, medical devices, cosmetics, and related health products. In Mexico, these activities are overseen primarily by the Federal Commission for the Protection against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios, COFEPRIS), rather than by the United States Food and Drug Administration (FDA). However, the term "FDA Law" is sometimes used informally to refer to the similar regulatory standards and compliance requirements that affect companies importing, exporting, manufacturing, or distributing regulated products in Mexico. These laws ensure public health and safety by enforcing standards for product quality, labeling, marketing, approval, and surveillance.

Why You May Need a Lawyer

Navigating FDA Law in Mexico can be complex due to strict regulations and ongoing updates to legislation. You may need a lawyer if you find yourself in any of the following situations:

  • You are a manufacturer or importer seeking to obtain a sanitary authorization or registration for food, pharmaceuticals, or medical devices.
  • Your business needs guidance on correct labeling or advertising rules for consumer health products.
  • You face enforcement actions, sanctions, or product recalls initiated by COFEPRIS or other authorities.
  • Your products have been detained at customs due to regulatory issues.
  • You are involved in disputes regarding patents, drug approvals, or licensing agreements.
  • You need to ensure compliance with both Mexican regulations and international standards.

Having legal counsel familiar with Mexican FDA Law helps minimize risks, avoid costly errors, and facilitates smooth interactions with regulatory agencies.

Local Laws Overview

The central piece of FDA Law in Mexico is the General Health Law (Ley General de Salud) and its associated regulations. COFEPRIS is the main regulatory authority that enforces these laws. Key aspects include:

  • Sanitary Registration: Most food, drugs, dietary supplements, medical devices, and cosmetics must obtain approval from COFEPRIS before they can be sold or distributed in Mexico.
  • Labeling and Advertising: Strict labeling rules ensure products accurately display required information, such as ingredients, warnings, usage instructions, and health claims. Advertising is closely monitored to protect consumers from misleading claims.
  • Clinical Trials and Research: Any clinical trial for drugs or medical devices must be registered and authorized by COFEPRIS before commencing.
  • Imports and Exports: Importers and exporters must comply with both Mexican laws and, in many cases, international treaties and standards for pharmaceutical and health products.
  • Post-Market Surveillance: There are mandatory requirements for reporting adverse events and product quality issues after a product reaches the market.
  • Enforcement and Penalties: Non-compliance can result in monetary fines, product recalls, closure of facilities, and criminal penalties in severe cases.

Frequently Asked Questions

What is the main regulatory agency for food and drug law in Mexico?

The Federal Commission for the Protection against Sanitary Risks (COFEPRIS) is the main regulatory body overseeing food, drugs, medical devices, and related products in Mexico.

Do I need a sanitary registration to sell my product in Mexico?

Yes, most food, drug, medical device, and cosmetic products require registration and approval from COFEPRIS before they can be legally sold in Mexico.

How long does the registration process with COFEPRIS take?

Timelines vary depending on the product category, dossier completeness, and regulatory workload. It can take several months to over a year for complex products.

Can foreign companies apply for product registration in Mexico?

Yes, but foreign companies usually need a local representative or legal entity in Mexico to apply for product registrations and act as the holder of the registration.

What are the labeling requirements for health products?

Labels must be in Spanish and include information such as active ingredients, usage instructions, warnings, expiration dates, batch numbers, and manufacturer details, following Mexican Official Standards (NOMs).

What should I do if my product is detained by customs?

Contact a lawyer or customs broker experienced in FDA Law to determine the cause of the detention and how to resolve regulatory or documentation issues with COFEPRIS or customs authorities.

Can I advertise health products freely in Mexico?

No, health product advertising is tightly regulated. Pre-approval may be required, and all claims or statements must adhere to Mexican law and COFEPRIS guidelines.

What are the penalties for non-compliance with FDA Law in Mexico?

Penalties range from fines and product recalls to facility closures and criminal charges, depending on the severity of the violation.

Are clinical trials required for all new drugs?

Most new pharmaceuticals and some medical devices require clinical trials registered and authorized by COFEPRIS to demonstrate safety and efficacy before approval.

Is FDA approval from the United States valid in Mexico?

No, FDA approval from the US does not substitute for COFEPRIS approval in Mexico. Separate applications and approvals are mandatory.

Additional Resources

If you need further information or assistance, consider contacting or consulting the following resources:

  • Federal Commission for the Protection against Sanitary Risks (COFEPRIS)
  • Mexican Secretariat of Health (Secretaría de Salud)
  • Mexican Pharmaceutical Association (Asociación Farmacéutica Mexicana)
  • National Chamber for the Pharmaceutical Industry (CANIFARMA)
  • Professional legal associations specializing in health or regulatory law in Mexico

Next Steps

If you require legal assistance with FDA Law in Mexico, consider taking the following steps:

  • Collect all relevant documentation related to your products or case, such as product formulations, labels, export-import papers, prior correspondence with COFEPRIS, and any test or certification results.
  • Research and identify law firms or attorneys with expertise in health, regulatory, or FDA Law in Mexico.
  • Schedule a consultation to discuss your situation and receive a detailed legal strategy or compliance plan.
  • Stay updated on regulatory requirements through professional organizations or governmental bulletins.
  • Ensure that your business maintains ongoing compliance and is prepared to respond quickly to any regulatory changes or enforcement actions.

Seeking timely legal advice can help you avoid complications, reduce risks, and ensure your products reach the Mexican market successfully and in full compliance with the law.

Lawzana helps you find the best lawyers and law firms in Mexico through a curated and pre-screened list of qualified legal professionals. Our platform offers rankings and detailed profiles of attorneys and law firms, allowing you to compare based on practice areas, including FDA Law, experience, and client feedback. Each profile includes a description of the firm's areas of practice, client reviews, team members and partners, year of establishment, spoken languages, office locations, contact information, social media presence, and any published articles or resources. Most firms on our platform speak English and are experienced in both local and international legal matters. Get a quote from top-rated law firms in Mexico - quickly, securely, and without unnecessary hassle.

Disclaimer:
The information provided on this page is for general informational purposes only and does not constitute legal advice. While we strive to ensure the accuracy and relevance of the content, legal information may change over time, and interpretations of the law can vary. You should always consult with a qualified legal professional for advice specific to your situation. We disclaim all liability for actions taken or not taken based on the content of this page. If you believe any information is incorrect or outdated, please contact us, and we will review and update it where appropriate.