Axiom Worldwide DRX9000(TM) Receives Final Market Clearance in Japan!

TAMPA, Fla.--(BUSINESS WIRE)--Japan’s Pharmaceutical Affairs Law (PAL) harmonizes the requirements of various international regulatory requirements and reduces the conflicting demands of these various regulations by incorporating the guidance documents of the Global Harmonization Task Force (GHTF). To sell medical devices in Japan, the PAL requires that two licenses be obtained. The device manufacturer must first obtain manufacturing accreditation for their manufacturing facilities. Second, a marketing authorization holder (MAH) must be assigned the responsibility for safety and effectiveness of the medical device in Japan.