Mexico COFEPRIS medical device registration

Qserve is your regulatory consultancy partner for medical device registration services in Mexico.

Regulatory submission

COFEPRIS Medical Device Registration

In Mexico, the process for submitting regulatory applications for medical devices is managed by the Federal Commission for Protection against Health Risks (COFEPRIS), which operates under the Ministry of Health. The main regulations overseeing medical devices in Mexico are the General Health Law (Ley General de Salud)xviii and the Health Supplies Regulations (Reglamento de Insumos para la Salud).

COFEPRIS handles a wide range of health-related regulatory tasks in Mexico, including food safety, pharmaceuticals, organ transplants, environmental protection, and Cofepris Medical device registration. Medical devices fall under its purview, and obtaining Cofepris Medical device registration is crucial for market entry.

“Our experts offer comprehensive services to streamline the process of bringing your products to the Mexican market and ensuring successful registration.”  

Regulatory Compliance in Mexico

COFEPRIS Medical Device Registration


We are an experienced partner in EU-MDR, EU-IVDR, and US FDA market access. Qserve has extensive expertise in market access in the US, Europe, and Mexico and knows the essential requirements to receive COFEPRIS approval and guide the process for COFEPRIS Medical Device Registration.

Benefits of Qserve engagement

Worldwide support

  • Qserve is a leading regulatory consulting firm offering medical devices and in vitro diagnostic regulatory and quality affairs services.
  • We specialize in helping clients achieve and maintain market access around the world.
  • Our team of experienced regulatory and quality experts have a deep understanding of the regulatory landscape and can help manufacturers navigate the complex requirements.
  • Qserve uses a practical approach to support you every step of the way. 

Do you need assistance with Medical Device Registration in Mexico or go-to-market strategy?

Qserve is your trusted partner for market access in Mexico. 

Contact us

Market access Mexico

Do you want to learn more about market access in Mexico and its regulations?

We help you with a quick overview of the following:

  • The COFEPRIS regulations
  • Classification system
  • Conformity assessment process
  • Mexican Registration Holder (MRH)
  • The difference with EU/US requirements
  • Important guidance links

More information

How Qserve can help

Meet our global registrations team to talk about our services:

  • Regulatory market access strategy
  • Registration support in Mexico
  • Risk classification assessment
  • Translation of labels and IFUs based on requirements
  • Compile Technical Documentation 
  • Set up your QMS-compliant system
  • Gap analysis
  • Risk management
  • Clinical studies and evaluation
  • Post-market surveillance

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