Regulatory submission
COFEPRIS Medical Device Registration
In Mexico, the Federal Commission for Protection against Health Risks (COFEPRIS) manages the regulatory application process for medical devices. COFEPRIS operates under the Ministry of Health and ensures that all medical devices meet the required safety and quality standards before entering the market.
The principal regulations governing medical devices in Mexico include the General Health Law (Ley General de Salud) and the Health Supplies Regulations (Reglamento de Insumos para la Salud). These regulations define the requirements and processes for obtaining approval.
COFEPRIS oversees various health-related regulatory areas, such as food safety, pharmaceuticals, organ transplants, and environmental protection. Medical device registration is one of its core responsibilities. Successfully obtaining COFEPRIS medical device registration is essential for entering the Mexican market and ensures your product complies with all legal and safety standards.
At Qserve, we simplify this process, helping you navigate the regulatory requirements and achieve timely approval. Let us help you confidently and quickly bring your medical device to the Mexican market.
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
Navigating the regulatory landscape in Mexico requires expertise, precision, and a clear understanding of COFEPRIS requirements. At Qserve, we bring extensive experience in global regulatory compliance, including EU-MDR, EU-IVDR, and US FDA processes, and tailor this expertise to support COFEPRIS Medical Device Registration.
We don’t just provide guidance. We partner with you to achieve successful market entry in Mexico. Here’s how Qserve supports you throughout the COFEPRIS registration process:
- Expert Regulatory Insights: Our team understands the specific requirements for COFEPRIS approval, ensuring your submission meets all necessary standards. From device classification to documentation preparation, we guide you through every step.
- Customized Dossier Preparation: We help you compile a registration dossier tailored to COFEPRIS requirements. This includes safety data, clinical trial reports, and testing documentation.
- Leveraging International Approvals: If your device is approved in regions like the US or EU, we help streamline the Mexican approval process by demonstrating compliance using these credentials.
- Dedicated Local Representation: We assist in appointing a trusted Mexico Registration Holder (MRH) to manage local regulatory interactions and ensure smooth communication with COFEPRIS.
Why Choose Qserve for COFEPRIS Registration
- Global Expertise: With experience in markets across the US, Europe, and Mexico, we understand the nuances of different regulatory environments.
- Practical Approach: We focus on actionable, efficient solutions that get results.
- End-to-End Support: From strategy to implementation, we’re with you every step of the way.
- Worldwide Network: Our global reach ensures consistent support wherever your business operates.
Qserve is more than a consulting firm; we’re your partner in achieving compliance and market access. Contact us today to see how we can make your journey to COFEPRIS approval efficient and stress-free.