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Medical Devices Regulatory Services In Mexico
Your regulatory partner for MedTech services in Mexico, from concept to market.
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.
Services
Regulatory Intelligence & Strategy
MDR Gap Assessment
Medical Device Regulatory Affairs
Quality Consulting
Technical and Medical Writing
Clinical, Performance Evaluation
Medical Device Registration / Certification
Authorized Agent / Legal Representation
Post Market Surveillance
Key Regulations for Medical Devices in Mexico
General Health Law
Regulation of Health Supplies
Classification Of Medical Devices
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.
For Medical Devices, from strategic planning and registration to post-market compliance, Artixio provides high-quality efficient regulatory affairs services to support your business in Mexico.
Why Artixio?
Local experienced staff with 15-35+ years of experience in Mexico
Regulatory intelligence driven strategies.
End to End Support from Product Conceptualization to Launch and Post Market Support
Tailored regulatory solutions for COFEPRIS compliance
Ensuring compliance for 200+ Devices and Diagnostics Products Licenses
Customer focused timely compliance with COFEPRIS guidelines
ISO 9001:2015, Quality Driven Services Platform
Flexible Business Models – Project Based; Long Term FTE based
FAQs
Is it necessary to appoint a local representative in Mexico for medical device commercialization?
Yes, it is mandatory for the foreign manufacturers to appoint a local representative for the regulatory procedures of their medical device.
Are clinical trials necessary for all medical device classes?
No, the clinical trial requirement depends upon the complexity of the class of device.
What are the labeling requirements of the medical device in Mexico?
The label on the medical device should be written in Spanish language and must comply with the NOM-137-SSA1-2008 standards.
For how long the medical device registration is valid in Mexico and when it should be renewed?
The medical device registration is valid for a period of 5 years, which should be renewed before its expiry to keep the registration valid.
Regulatory Expertise Across
Multiple Countries
India
Vietnam
Mexico
Vietnam
United States
Brazil
Europe
Malaysia
Taiwan
China
Thailand
Philippines
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