Qualtech has started providing regulatory services for medical device manufacturers who aim for the Japanese market. Taking this opportunity, we would like to provide a brief introduction of what Japanese regulation requires for foreign manufacturers to sell their products in its market.more
Product Registration, Clinical Trials, Local Representative, and Regulatory Services
Qualtech Consulting Corporation, founded in 2000 by Dr. Yin-Pen Chang, is a regulatory consulting service and clinical trial (CRO) company for medical devices. Operating with a cross-disciplinary team of professionals, integrity, diversity, continuous learning, and teamwork, Qualtech provides clients with effective one-stop solutions.
We have helped over 1,000 clients to gain market access in their desired locations and passed more than 5,000 medical device licenses with precision.