DigniCap Delta receives market approval in Japan
Dignitana announces that DigniCap Delta received market approval in Japan from the Ministry of Health, Labor and Welfare (MHLW). In Japan, Dignitana will provide DigniCap Delta to Konica Minolta as a medical device manufacturer, and Konica Minolta will proceed as a market authorization holder (MAH) to expand into the Japanese market.Regulatory approval for medical devices in Japan is similar to the FDA clearance process for medical devices in the United States, it is a pathway in which quality, efficacy, and safety are examined and approved