MDREX is a professional consulting firm that supports digital health and medical device companies with market entry.

We provide comprehensive solutions to ensure that our clients' products and services successfully enter their target markets, whether it be in Korea, Japan, the United States, Europe, or other Asian countries.

In the medical device and digital health sectors, regulatory issues are directly linked to the success or failure of a business. Therefore, it is essential to identify and address the regulatory requirements of each target market in advance to develop and validate products and services accordingly.

MDREX is composed of former professionals from the Ministry of Food and Drug Safety (MFDS), the Health Insurance Review and Assessment Service (HIRA), and global regulatory experts with years of experience at a prestigious law firm. With such expertise, we offer clients the most effective approaches and solutions for regulatory issues, including product approvals, reimbursement listings, etc.

Leveraging our extensive experience and accumulated know-how, MDREX is committed to delivering the best possible outcomes for our clients and making every effort to achieve their goals most effectively.