Taiwan’s FDA has issued a Good Distribution Practice Guideline for Medical Devices. With the new guidelines getting into force in the near future, relevant distributors will be required to obtain a GDP certificate before they can legally distribute medical equipment.more
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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.