Navigating the Mexican Regulatory Landscape: An Interview with R. Yoloxóchitl Macias Ortega of Anglex Consultores
The following is a clean verbatim transcript from an episode of The Elendi Files.
Host Teddy, General Manager of ElendiLabs, speaks with R. Yoloxóchitl Macias Ortega from Anglex Consultores to discuss the complexities of entering the Mexican medical product market and the pivotal role of the health authority, COFEPRIS.
Teddy: Welcome to The Elendi Files, where we navigate the complexities of the global regulatory landscape of medical products. Our goal is to help make global medical product regulations accessible to everyone—whether you're a manufacturer, regulatory specialist, or CEO of a med-tech startup, you’re in the right place. At ElendiLabs, we connect clients with the right regulatory expertise to get products to people faster.
Today, I'm thrilled to be joined by R. Yoloxóchitl Macias Ortega from Anglex Consultores, a firm that has become a cornerstone for navigating the intricacies of the Mexican market. Yolo, could you give us a brief introduction of what Anglex Consultores specializes in?
Yoloxóchitl Macias Ortega: Of course. Anglex Consultores is a consultancy company that helps facilitate the process of obtaining a sanitary register in Mexico for every kind of product—including medical devices, medicines, supplements, and cosmetics. While we specialize in Mexico, we also help clients get licenses in Colombia, Brazil, Argentina, Central and South America, and even the US. Beyond registration, we provide training, auditing, and post-market surveillance, such as pharmacovigilance and technovigilance. We also act as a legal representative or "host" for foreign companies that do not have a local office in Mexico.
Costs and Timelines at a Glance
Teddy: Let’s dive a bit deeper. What are the costs and timelines like for registering a Class 1 medical device in the Mexican market?
Yoloxóchitl Macias Ortega: For a Class 1 medical device, the government fee for COFEPRIS is approximately $920 USD. This fee must be paid by the manufacturer. The timelines to obtain the license are currently between six to twelve months.
| Regulatory Aspect | Details for Class 1 Medical Devices |
|---|---|
| COFEPRIS Government Fee | Approximately $920 USD |
| Current Timeline | 6 – 12 Months |
| License Validity | 10 Years |
| Digitalization Status | ~30% Digital (DIGIPRIS), ~70% Paper |
The Digitalization Challenge: DIGIPRIS
Teddy: Some people describe COFEPRIS as a bit of a "black box." I’ve noticed there is a digitalization effort called DIGIPRIS. Is it helping to speed things up?
Yoloxóchitl Macias Ortega: DIGIPRIS was launched around 2022 or 2023. However, the digitalization process is not yet complete. While several processes are moving toward digital, medical device submissions are still currently handled via paper dossiers. We estimate it will take about two more years to have the complete digitalization process finished. Right now, it is roughly 30% digital and 70% paper submission.
Documentation and Language Requirements
Teddy: Regarding documentation, do they have to be in Spanish, or does COFEPRIS accept English?
Yoloxóchitl Macias Ortega: Certain documents must be in Spanish, specifically the Instructions for Use (IFU) and the labels. However, most of the technical information can be submitted in English. This saves manufacturers a significant amount of money because they don’t have to translate massive technical files.
Leveraging Equivalence Agreements
Teddy: Mexico has equivalence agreements for products already approved by the US FDA, Japan's MHLW, and Health Canada. How much time and money does this save?
Yoloxóchitl Macias Ortega: With an equivalence agreement, the approval timeline is around eight months to one year, depending on the complexity of the dossier. It saves money because the technical information required is less; we can submit summaries or resumes of biocompatibility, laboratory, and stability tests rather than the full data sets. The dossier is significantly smaller than the traditional pathway.
Avoiding the "Distributor Hostage" Situation
Teddy: A concern for many manufacturers is being held "hostage" by a distributor who holds their registration. How does Anglex help with that?
Yoloxóchitl Macias Ortega: We offer a hosting service where we act as the legal representative and holder of the sanitary register without having any commercial involvement in sales or distribution. This allows the manufacturer to maintain independence and control, giving them the freedom to contract multiple distributors without generating conflicts.
License Validity and Post-Market Vigilance
Teddy: How long is the validity of a license in Mexico?
Yoloxóchitl Macias Ortega: Regulations have recently changed, and the life of a license is now 10 years. This harmonizes Mexico with Colombia, which also has a 10-year validity.
Teddy: What about post-market surveillance or technovigilance?
Yoloxóchitl Macias Ortega: Previously, technovigilance reports were submitted every five years. Since the change to 10-year licenses is new, we are still confirming if reports will move to a 10-year cycle. Regarding safety case reporting, if an incident occurs where a user is injured, the manufacturer or holder must notify COFEPRIS as soon as possible, generally within 72 hours.
Strategic Family Grouping
Teddy: Finally, can you explain family grouping and how a smart strategy reduces costs?
Yoloxóchitl Macias Ortega: Some agencies suggest registering one SKU per license, which is very expensive. The best way is to group devices based on the intended use. If the indication of use is the same, and the only differences are dimensions, measures, or colors, you can include them all in one license. We recently helped a company save around $5,000 by reviewing their information and grouping what they thought would be seven licenses into just one.
Teddy: These are incredibly practical, "boots-on-the-ground" insights. Yolo, thank you for joining us. We will be featuring Anglex Consultores as a vetted specialist firm on the ElendiLabs’ platform.
