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.
GO-TO-MARKET STRATEGY AND REGISTRATION SUPPORT
Do you need assistance with Medical Device Registration in Mexico or go-to-market strategy?
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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.