What is COFEPRIS certification? It’s essential if your company is willing to compete in international markets. While there’s no doubt that the MedTech business offers numerous opportunities, it is also necessary to be aware of several regulatory requirements.
At RexMed Health, we are committed to helping partners stay aligned with Mexican and international regulatory standards, ensuring safe and compliant manufacturing for export-grade medical devices. If your goal is to enter or expand in global markets, understanding the COFEPRIS certification pathway is critical. Let’s walk through the key steps.
Understanding NOM-241
To understand COFEPRIS certification, it is necessary to discuss NOM-241. Created by the commission, this standard establishes minimum requirements for the design, development, and distribution of medical devices by domestic manufacturers. Foreign companies that wish to enter the Mexican market must comply with it as well.
This standard prioritizes quality management. It aligns closely with ISO 13485 yet doesn’t supersede NOM-241. COFEPRIS urges manufacturers to incorporate good practices throughout the entire development cycle.
Good news: Mexican regulatory pathways often leverage FDA-aligned documentation. Since COFEPRIS guidelines closely align with those of the FDA, exporting there is easier.
In summary, any company wishing to produce or import products to Mexico must comply with NOM-241. However, there are several steps you must take before manufacturing can begin.
COFEPRIS Certification Roadmap
Fortunately, COFEPRIS has made the regulatory pathways easier by creating a web portal called DIGIPRiS. Much of this process with this institution is now online. We will guide you through the process below.
- First, your company must be pre-registered with COFEPRIS. This applies to importers, distributors, and manufacturers. This allows your organization to be legally recognized as authorized to work with medical devices.
- Next, obtain a certificate of compliance with NOM-241-SSA1-2025. COFEPRIS issues this certificate to ensure that your company complies with good practices.
- Next, classify the medical device according to its risk level. The Mexican commission typically provides lists of classified products to help you navigate the process.
- Gather all the documentation for the device’s technical file. This includes certificates, labels, post-market surveillance reports, and studies conducted on the device.
- The DIGIPRiS system will issue an Electronic Payment Reference. This allows you to pay the required fee for this procedure.
- From the DIGIPRiS portal, submit an online application and upload all the documents you have gathered.
During this process, COFEPRiS may issue observations that you must correct to receive compliance approval. Once everything is in order, you will receive a health registration ruling indicating that the certification has been approved.
Export Readiness
People believe COFEPRIS certification is just a local formality required for trading in Mexico. However, this is far from the truth. Medical exports from Mexico heavily depend on compliance with all relevant regulations.
COFEPRIS has made great efforts to harmonize its regulations with those of many countries, especially its neighbors and trading partners. Geographically, the United States is one of the leading destinations for Mexican medical devices.
Still, Mexico’s location allows it to maintain contact with the rest of the continent. If you can comply with strict FDA regulations, you won’t have any problems in Latin America. Of course, this is only true if you follow the above steps precisely.
It is worth noting that Mexico has implemented several notable reforms. For example, they have implemented DIGIPRiS and reduced review times. These reforms continue to facilitate access to national certifications for manufacturers and exporters.
Institutional Confidence
How can you establish trust when selling a product? Put simply, you must adhere to quality standards. People want to protect their money, and COFEPRIS rules are vital for that.
- Check the facilities and equipment. Examine how they sterilize tools and control the spread of infections. This reduces patient risks. Their safety must be an absolute priority.
- COFEPRIS certification is absolutely vital for legal protection. Without this official proof, institutional sales are nearly impossible. Your device must meet all the rules.
- As mentioned earlier, this regulation ensures good manufacturing practices are used. This enables you to offer a high-quality product that inspires confidence in your buyers.
Not to mention the enormous weight it carries in terms of compliance with international regulations, thanks to COFEPRIS certification, selling, distributing, and exporting MedTech products will no longer be a problem.
COFEPRIS Certification Link with ISO 13485
As we’ve discussed, certification and NOM-241 align with ISO 13485. But do you know why? First, in both cases, the goal is to ensure the quality of the devices.
It is also essential to comply with these regulations in light of international trade agreements. This is the case with the USMCA, for which COFEPRIS has worked to harmonize its regulations.
Compliance with these regulations demonstrates the manufacturer’s commitment to quality and safety. Maintaining quality and safety standards inspires confidence in potential partners and buyers. Therefore, this should be the primary concern of any MedTech company.
The Solution for Producing MedTech in Mexico
We know this process can seem cumbersome. There are many things to keep track of, so it’s best to leave everything in the hands of experts. Fortunately, RexMed is one of the best manufacturing options in Mexico.
We are familiar with the market and understand the necessary regulations, ensuring compliance. Want to know more? Visit the Contact section on our website.
FAQs
What are Class I devices for COFEPRIS?
They are well-known medical supplies whose safety and efficacy have been proven. Examples include gloves, bandages, face masks, and crutches.
What are COFEPRIS Grade II devices?
These devices may vary in the materials they are made of or their concentrations. They are generally introduced into the body for less than 30 days. Examples include syringes, contact lenses, and transfusion equipment.
What are COFEPRIS Class III devices?
These are life-sustaining devices that have recently been accepted or will remain in the body for more than 30 days, and in most cases, for the life of the patients. Classic examples include pacemakers and hip prostheses.
