DRX 9000 Spinal Decompression NYC
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.
Axiom Worldwide’s foreign manufacturing accreditation certification was received on October 31, 2007. This includes quality management systems (QMS) requirements based on ISO 13485:2003 with additional requirements stipulated from the Japanese Ministry of Health, Labor and Welfare (MHLW) from Ministerial Ordinance 169. Axiom’s foreign manufacturing accreditation covers the manufacturing of products for the Japanese market.
Axiom Worldwide’s Marketing Authorization Holder (MAH) received the Marketing License for the DRX9000™ on May 8, 2008. Obtaining a device license involves an evaluation of technical documentation for the designated medical device. This is similar to the requirements outlined in the Global Harmonization Task Force’s Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices. The MAH must also demonstrate an effective quality management system in Japan, separate of the manufacturer, and be assessed for conformance to Facilities requirements (MHLW Ordinance #2) and GMP Requirements (MHLW Ordinance #169).
Japan has very specific policies and stringent processes in place to make sure that medical devices sold in Japan are safe and effective. Axiom Worldwide has met one of the most demanding quality standards in the world. Having met the regulatory requirements in Japan is a testament to the company’s worldwide commitment to manufacture quality non-surgical products that are safe and effective in treating patients suffering with chronic back pain