Medical Device Regulatory Services in Mexico

Your regulatory partner for Medical devices regulatory affairs services in Mexico, from concept to market. End-to-end regulatory support for medical device registration, compliance, and approvals in Mexico with Artixio’s expert consulting team.

Medtech

Services We Offer

Solution by Countries

Our Industries

Medical Device Regulatory Affairs Consultant in Mexico

Artixio provides seamless regulatory services for commercialization of your medical device in the Mexican market. Our experienced local team in Mexico helps you navigate through the stringent guidelines of COFEPRIS and achieve timely compliance. We aim at helping our clients right from product conceptualization until product surveillance.

Key Regulations for Medical Devices in Mexico

General Health Law

Regulation of Health Supplies

Classification Of Medical Devices in Mexico

In Mexico, devices are classified to Class I, II and III depending on their risk level. Class I devices have low risk to patients, while Class III devices are high risk, complex devices. However, all three classes require approval from the COFEPRIS. Class I requires minimal documents; class II requires moderate documents whereas class III requires stringent in-depth documents.

Process For Registration Of Medical Devices In Mexico

Documents Required For Medical Device Registration In Mexico

Application Form
Description
Power of Attorney
Labeling Information
Certificate of Free Sale (CFS)
Clinical Data (for Class II & III)
Good Manufacturing Practices (GMP) Certificate
COFEPRIS registration fee receipt.

Artixio’s Medical Devices Registration Services in Mexico

Our Regulatory and Market Access experts based in Mexico, coupled with the Global Regulatory Projects team, have assisted over a hundred pharmaceutical, medical devices, diagnostics, cosmetics, nutraceuticals, supplements, and veterinary products successfully register and maintain compliance with COFEPRIS in Mexico. Coupled with the Artixio’s intelligence-based services platform, Dvarka, innovators and manufacturers around the globe have benefited by seamlessly managing the regulatory strategy for the product development and commercialization value chain.

Mexico COFEPRIS medical device regulations, from strategic planning and registration to post-market compliance, Artixio provides high-quality efficient regulatory affairs services to support your business in Mexico.