25 years
of experience
We have obtained
20+ Awards
Time in Mexico

HEALTH

About the area

At bgbg, our healthcare consulting services are grounded in a deep understanding of the sector’s regulatory framework and the operational dynamics of its stakeholders.

We advise our clients on designing robust legal structures, complying with their regulatory obligations, and handling disputes, integrating healthcare law with other legal disciplines relevant to the sector, including data protection, intellectual property, and corporate law.

Our approach combines technical expertise in the applicable regulatory framework—including the General Health Law, the Health Supplies Regulation, the relevant National Technical Standards (NOMs), and the regulations issued by the Federal Commission for Protection against Health Risks (COFEPRIS)—with practical experience in the operation of public and private healthcare institutions.

Clients and industries

We advise hospitals, clinics, laboratories, diagnostic centers, clinical research institutions, pharmaceutical companies, manufacturers and importers of medical devices, digital health startups, health insurance providers, and healthcare professionals.

We also work with decentralized public agencies and public sector entities, as well as with international clients seeking to establish operations in Mexico within the healthcare sector.

Main Services

Health Regulations and COFEPRIS

Consulting services regarding compliance with the applicable healthcare regulatory framework for companies, institutions, and professionals in the sector, including administrative procedures, authorizations, and processes involving COFEPRIS and other competent authorities. This includes handling on-site inspections, requests for information, and administrative proceedings arising from actions taken by health authorities.

Health records and pharmacovigilance

Consulting services for obtaining, amending, renewing, and defending health registrations with COFEPRIS, including drugs, medical devices, dietary supplements, and healthcare supplies. This includes regulatory strategy, preparation of technical dossiers, and support for pharmacovigilance and technovigilance processes in accordance with applicable regulations.

Healthcare facilities

Consulting services regarding the establishment, authorization, and operation of healthcare facilities, including hospitals, clinics, laboratories, and diagnostic centers. This includes obtaining health licenses, operating permits, and registrations with federal and local authorities, as well as the legal structuring of their governing bodies.

Contracts and documentation

Drafting, reviewing, and negotiating contracts and agreements related to the provision of healthcare services, the supply of medical supplies, medical collaboration, research, new product development, and the structuring of medical services, ensuring compliance with applicable healthcare regulations.

Telemedicine and Digital Health

Legal structuring of telemedicine models, digital health applications, and remote healthcare platforms, taking into account applicable healthcare regulations, the personal data protection framework, and electronic health record requirements. This is particularly relevant for healthcare startups and technology companies that integrate medical services into their platforms.

Healthcare Regulatory Compliance

Design and implementation of regulatory compliance programs tailored to the healthcare sector, including the identification of applicable obligations, the development of internal policies, regulatory risk assessments, and support during regulatory oversight processes. This service is provided in coordination with bgbg’s specialized Compliance department.

Protection of Personal Health Information

Consulting on the processing of sensitive personal data in the healthcare sector, including the drafting of privacy notices, data processing policies, privacy impact assessments, and responding to requests from the National Institute of Access to Information (INAI). This service takes into account the interplay between the obligations under the Federal Law on the Protection of Personal Data and Personal Information (LFPDPPP) and the healthcare regulations applicable to the handling of clinical information and medical records. This service is provided in coordination with bgbg’s specialized Compliance department.

Controversies and litigation

Legal representation in disputes related to the healthcare sector, including:

  • Representation before COFEPRIS, the National Medical Arbitration Commission (CONAMED), and other authorities.
  • Handling and resolving requests issued by local and federal authorities.
  • Legal representation in civil lawsuits related to the provision of health care services.
  • Enforcement of security interests and disputes arising from breach of contract.
  • Claims for property damage, emotional distress, and civil liability.

Testimonials

“

Clients are quick to praise the firm, saying enthusiastically: “The service they provide is highly satisfactory. They understand the client’s needs and have a good sense of urgency.”

Chambers and Partners Latin America 2020 client feedback on the Banking & Finance Department
“

“The service is of a very high standard; they are very thorough and up-to-date on all matters, and the partners are always available and deliver on time.”

Chambers and Partners Latin America 2020 client feedback on the Compliance Department

Our team combines technical expertise in healthcare law with practical experience in the operation of healthcare institutions, enabling us to provide business-oriented advice, anticipate regulatory risks, and support our clients in environments subject to active oversight. We understand that the healthcare sector operates within a demanding and constantly evolving regulatory framework—and we work to ensure that our clients have the support and legal certainty they need to operate with confidence.

More about Health