MEKICS Completes Approval for ODM Respiratory Care Devices in Japan... Market Entry Imminent

MEKICS is accelerating its expansion in the Japanese market, having brought its long-standing market entry project to the final stages. With the completion of both the Pharmaceuticals and Medical Devices Agency (PMDA) approval and its partner company's quality verification process, the company is now on the verge of officially launching its supply operations.

On July 1, MEKICS, a company specializing in respiratory care (CEO Kim Jongchul), announced that it has completed all major procedures for entering the Japanese market and is now preparing for local supply.

Previously, the company signed an ODM (Original Design Manufacturing) contract with a leading Japanese ventilator rental business. However, the project faced difficulties due to local medical device regulations and a rigorous quality verification process. By dedicating its organizational resources to relaunching the initiative, MEKICS ultimately overcame these long-standing challenges, securing PMDA approval and passing the final quality verification by its Japanese partner.

Completing preparations for supply in the Japanese market—which is known for its high entry barriers in the medical device sector—serves as evidence of MEKICS’s advanced respiratory care technology and global regulatory compliance capabilities. The company plans to leverage this achievement to foster the Japanese market as a new global growth hub.

Notably, this entry into Japan is significant in that it secures both profitability and market scalability by separating the supply structures for equipment and consumables.

The respiratory care equipment will be supplied via ODM, utilizing the Japanese partner company’s brand. Given that a prominent medical device company with high brand recognition and market dominance in Japan will launch its own branded products based on MEKICS’s technology, the company anticipates rapid market penetration by leveraging existing medical networks and trust.

In contrast, dedicated consumables that require ongoing replacement during patient care will be supplied under MEKICS's own brand. The company will use its partner’s nationwide rental and sales network to expand equipment distribution, and will directly secure recurring sales from consumables over the long term.

This is an example of MEKICS applying the “equipment and consumables linkage (lock-in) model” developed in the domestic market to overseas markets. By expanding equipment sales and building a stable foundation for consumables revenue, the company aims to establish a long-term profit structure.

The equipment products are scheduled to be shipped and supplied sequentially according to the Japanese partner’s launch schedule. Both companies are preparing for commercialization targeting medical institutions throughout Japan.

The dedicated consumables, expected to be a core revenue source, have already completed their initial export last week, marking the first step toward entering the local market. The Japanese distributor in charge of sales is a leading company with a nationwide sales and rental service network, and the pace of MEKICS’s product and consumables expansion in Japan is expected to accelerate as the equipment launches.

A MEKICS representative stated, "This Japanese project is highly significant in that it has revived a long-delayed initiative and established a supply system capable of generating sales at any time. Having our technology recognized in the market with the strictest regulatory environment, we will proceed with equipment supply in line with our partner’s launch schedule and grow our consumables sales as well, positioning Japan as a key global revenue base."

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