Best FDA Law Lawyers in Mexico City

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Justicia Transparente

Justicia Transparente

30 minutes Free Consultation
Mexico City, Mexico

Founded in 2000
30 people in their team
Spanish
English
Business FDA Law Tax +1 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
Mexico City, 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.

Ojeda y Caro S. C.

1 hour Free Consultation
Mexico City, Mexico

Founded in 2016
20 people in their team
French
Portuguese
Spanish
English
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...
Esposito & Assocs. Law Firm
Mexico City, Mexico

Founded in 2003
3 people in their team
English
Immigration & Corporate Lawyers in Mexico | Esposito & AssociatesAt Esposito & Associates, we’ve been helping clients since 2003 with clear, reliable legal support. We’re a team of experienced lawyers who specialize in different areas of law, and we work together to guide you...
Bucio Carrillo y Poo, S.C
Mexico City, Mexico

Founded in 2020
3 people in their team
English
Bucio Carrillo y Poo, S.C., established in 2016 and headquartered in Mexico City, is a comprehensive law firm offering a broad spectrum of legal services. The firm's team of seasoned professionals brings extensive experience and a proven track record in areas such as corporate law, immigration law,...
Robert Wray PLLC, Mexico Office
Mexico City, Mexico

Founded in 2020
3 people in their team
English
Robert Wray PLLC, Mexico Office, is a distinguished law firm renowned for its comprehensive legal expertise and strategic advisory services. With a solid foothold in the Mexican legal landscape, the firm excels in providing tailor-made solutions across a spectrum of legal areas, including...
De Hoyos Aviles
Mexico City, Mexico

Founded in 1964
50 people in their team
English
Spanish
De Hoyos y Aviles is a Mexican Law Firm founded in 1964. Its partners have an overall experience of at least twenty years working on real estate and commercial transactions, M&A, and/or complex litigation cases. The firm's partners have an international profile; part of their daily practice is...
Recovery Legal Mexico

Recovery Legal Mexico

1 hour Free Consultation
Mexico City, Mexico

Founded in 2019
5 people in their team
English
Spanish
Recovery Legal is a distinguished law firm with over 19 years of experience, specializing in legal recoveries and consultancy services across various sectors, with a primary focus on the insurance industry. Their team of specialized attorneys is dedicated to understanding each client's unique...
Odilisa Gutiérrez & Asociados
Mexico City, Mexico

Founded in 2020
8 people in their team
English
Odilisa Gutiérrez & Asociados is a distinguished law firm highly specialized in Mexican Agrarian Law. This focus allows us to provide legal counsel with a level of technical precision that few firms can match. We advise clients who require deep knowledge of Mexico’s agrarian legal...
Toledo, Sánchez Abogados, S.C.
Mexico City, Mexico

Founded in 2020
3 people in their team
English
Toledo, Sánchez Abogados, S.C. is a distinguished law firm located in Cuajimalpa de Morelos, Mexico City, at Vasco de Quiroga 3900, Lomas de Santa Fe, Contadero, 01219 Ciudad de México, CDMX, México. The firm operates from Monday to Sunday, 8:00 AM to 8:00 PM, providing comprehensive legal...
AS SEEN ON

About FDA Law in Mexico City, Mexico

FDA Law in Mexico City refers to the legal framework that regulates the production, distribution, import, export, and commercialization of food, drugs, medical devices, and other products intended for human consumption and health care. Unlike the United States, Mexico does not have a government agency called the FDA. Instead, these matters are governed and enforced primarily by the Federal Commission for the Protection against Sanitary Risk, known as COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios). Mexico City's role as the nation's capital also means it is a hub for regulatory oversight, compliance checks, and legal proceedings related to these sectors.

Why You May Need a Lawyer

There are many scenarios where professional legal assistance is crucial in navigating FDA Law, or more accurately, health regulatory law overseen by COFEPRIS. You may need a lawyer if you are:

  • Importing or exporting food, pharmaceuticals, cosmetics, or medical devices
  • Launching or registering new products for sale in the Mexican market
  • Facing compliance audits or investigations by COFEPRIS
  • Responding to product recalls, seizures, or bans
  • Seeking proper product labeling, advertising, or marketing approvals
  • Challenging regulatory sanctions or fines
  • Pursuing product registrations, health authorizations, or related permits
  • Needing advice on cross-border regulations for international companies
  • Involved in M&A, licensing, or distribution agreements where regulatory due diligence is needed

Legal experts help you prevent costly mistakes, ensure compliance, defend your interests, and facilitate business operations within proper legal bounds.

Local Laws Overview

FDA-related law in Mexico City falls under federal jurisdiction as established by the General Health Law (Ley General de Salud), enforced through COFEPRIS. Key aspects include:

  • Product Registration and Approvals: All medicines, medical devices, food supplements, and specific foods must be approved and registered by COFEPRIS before being marketed.
  • Manufacturing and Sanitary Licenses: Facilities must obtain operating licenses and comply with Good Manufacturing Practices (GMP) enforced by local and federal authorities.
  • Labeling and Advertising: Packaging and promotional materials must adhere to Mexican Official Standards (NOMs) to protect consumers and prevent misleading information.
  • Import and Export Controls: Importers and exporters need permits and must comply with sanitary requirements for cross-border movement of regulated products.
  • Inspections and Enforcement: COFEPRIS conducts facility inspections and can impose penalties, suspend activities, or seize products found non-compliant.
  • Recalls and Health Alerts: There are legal obligations to report adverse events, execute recalls, and notify health authorities of risks associated with products.
  • Clinical Trials / Research: Clinical studies require specific permits and ethical approvals, with legal processes set out in the General Health Law.

Complying with these regulations is essential for legal operation and consumer safety in Mexico City and throughout Mexico.

Frequently Asked Questions

What is COFEPRIS and what does it do?

COFEPRIS is the main federal authority in Mexico responsible for regulating food, drugs, medical devices, and various products that affect public health. It oversees product registration, compliance, manufacturing licenses, and enforcement actions.

Do all drugs and medical devices need registration in Mexico?

Yes, before being marketed or distributed in Mexico, drugs and most medical devices must be registered with COFEPRIS and receive official authorization.

Are foreign products subject to the same laws as Mexican-made products?

Yes, all products-whether imported or locally produced-must comply with Mexican health regulations, including registration, labeling, and quality standards.

What happens if my product does not meet Mexican labeling standards?

Products not in compliance with labeling standards may be seized, removed from the market, or lead to fines and sanctions. Proper adjustment and prior legal review is recommended.

How long does the registration process usually take?

The timeline for product registration varies. For pharmaceuticals, it can take from several months up to a year, depending on the classification, complexity of the application, and current backlog.

Can COFEPRIS conduct surprise inspections?

Yes, COFEPRIS officers can perform unannounced inspections of manufacturing, distribution, and retail facilities to ensure compliance with health regulations.

What are the consequences of non-compliance?

Penalties for non-compliance include fines, suspension or revocation of sanitary licenses, product confiscation, recalls, and in extreme cases, criminal charges.

What documentation is needed to register a new food supplement?

You typically need technical dossiers, safety and efficacy data, ingredient specifications, proposed labeling, and manufacturing information, all in line with Mexican standards.

Can I advertise health products freely in Mexico?

No, all advertising of health products is strictly regulated and must be pre-approved by COFEPRIS to prevent false or misleading claims.

How can a lawyer help if my product is seized?

A lawyer can help you understand the grounds for seizure, prepare a legal response or appeal, negotiate with authorities, and guide you in corrective actions to recover your product or minimize penalties.

Additional Resources

The following resources and organizations are useful for those seeking more information about health and regulatory law in Mexico:

  • COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios): Main regulatory body for food, drug, and health products
  • Ministry of Health (Secretaría de Salud): Sets public health policy and standards
  • Mexican Official Standards (Normas Oficiales Mexicanas or NOMs): Technical regulations for different products and processes
  • Chamber of the Pharmaceutical Industry (CANIFARMA): Industry representation and compliance support
  • Mexican Association of Pharmaceutical Research Industries (AMIIF)
  • Local health departments in Mexico City: For city-specific requirements and support

A knowledgeable attorney can also provide access to specialized regulatory resources and updates relevant to your business or concern.

Next Steps

If you believe you need legal guidance related to FDA law or health regulatory issues in Mexico City, consider the following actions:

  • Gather relevant documentation relating to your product, business, or regulatory issue
  • Prepare a summary of your case or specific questions you may have
  • Contact a qualified attorney specializing in health law, regulatory compliance, or administrative law in Mexico
  • Request an initial legal consultation to assess your case and options
  • Stay informed about updates in local laws and health regulations that may affect your operations

Legal advice tailored to your situation can save you time, prevent costly mistakes, and ensure you are fully compliant with Mexican law. Take prompt action to protect your business and your rights in this highly regulated field.

Lawzana helps you find the best lawyers and law firms in Mexico City 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 City, 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.