MEKICS Secures COFEPRIS Certification and Annual Supply Contract in Key Latin American Market, Mexico

MEKICS, a company specializing in respiratory therapy, is accelerating its global market expansion by successfully entering Mexico, a key medical device market in Latin America, following its entries into the United States and Japan.

On July 7, MEKICS announced that its flagship respiratory therapy device, the HFT750, has completed product registration with Mexico's medical device regulatory authority, COFEPRIS. At the same time, the company has signed an annual supply agreement with a major local partner that operates a nationwide distribution network for hospital consumables in Mexico.

Mexico is the second-largest medical device market in Latin America, with a strategic annual growth rate of 10.8%. In particular, COFEPRIS is known for its strict requirements for clinical data, technical document reviews, and lengthy verification processes, and is considered one of the most demanding medical device regulatory agencies in Latin America.

MEKICS explained that by completing this product registration, it has overcome significant regulatory barriers and once again demonstrated its respiratory therapy technology and quality management capabilities.

The company has not only obtained certification but also secured an annual supply contract. Unlike a one-time delivery, this is a long-term agreement, with the scale of dedicated consumables alone—an area MEKICS is strategically expanding—amounting to approximately 10,000 units. By establishing a structure in which high-margin consumables are supplied continuously for patient treatment after equipment sales, the company has secured a stable revenue base.

The local partner that signed the contract is a company with a hospital network and medical consumable distribution channels across Mexico. MEKICS stated that the secured supply volume will be gradually distributed to medical institutions nationwide through this network.

MEKICS recently completed its first shipment to the U.S. market, received PMDA approval in Japan, and completed its initial export of consumables to Japan last week, thereby continuing to expand its global business.

A company representative said, "This contract in Mexico, following our first shipment to the United States, PMDA approval in Japan, and our initial consumable exports, demonstrates that our global business has moved beyond the entry stage and is now entering a phase of substantial revenue growth. By securing an annual supply contract in Mexico, where regulatory hurdles are high, and establishing a supply base for about 10,000 units of consumables, we will use this as a foothold to further expand our presence in the Latin American market."

MEKICS has simultaneously achieved both market penetration and a recurring revenue base in Latin America by passing Mexico's strict medical device regulatory process and securing an annual supply contract.

This content was produced with the assistance of AI translation services.